By LESLIE BARKER GARCIA
DALLAS — Jennifer Tyler was driving down a country road in Oklahoma a couple of years ago when she noticed something odd. The telephone poles all had kinks in them.
"I thought, 'Wow, what's all that about?'" says Tyler, a Dallas fundraising consultant. "They all had distinctive bends in the middle."She pulled off the road and called a friend. "I knew something bad was happening," she says. "It was nothing I could ignore."Her friend referred Tyler to Texas Retina Associates. Tyler made an appointment and was diagnosed as having age-related macular degeneration.
AMD is a disease that causes significant vision loss in 1.75 million Americans. More than 10 million suffer from various forms of this potentially sight-stealing disease, more than glaucoma and cataracts combined, according to the American Macular Degeneration Foundation.By 2020, as the population ages, that number is expected to double.In addition, says Dr. Karl Csaky (pronounced like chalky) of the Retina Foundation of the Southwest, "more severe forms will be more of an issue."
"People who are in their 70s and 80s are extremely active," says Csaky, head of the foundation's Harrington Molecular Laboratory and an ophthalmologist with Texas Retina Associates. "If you had even a relatively small disturbance in vision, that could be extremely devastating in terms of what you're used to doing."Some vision disturbances, such as difficulty reading small print, are inherent with aging. The lenses of our eyes change and can no longer focus close up, so we rely on reading glasses.
Macular degeneration goes beyond the normal aging process. It affects the center of the retina; specifically, the 0.1 percent that's responsible for 99.9 percent of our fine vision, Csaky says."Unfortunately," Csaky says, "the central part is what gives you quality of life, the ability to read, drive, play golf, to discern faces."
He uses the analogy of a camera to explain the difference between normal eye aging and macular degeneration."The lens of the eye is like the lens of a camera," he says. "Cataracts are when the lens of the camera gets cloudy and the picture gets fuzzy. The solution? Change your lens, which is what cataract surgery is."In macular degeneration, your film has gotten old. We can change lenses, put in a special lens, and still have a bad picture because the film is starting to decay."
Macular degeneration has no cure, but those involved in studying and treating it point out glimmers of hope:Though it may cause legal blindness, rendering some victims unable to drive or read, it won't cause total blindness.Most kinds never progress past the initial stage. Diagnosis is not "a death sentence for vision," Csaky says.
Treatments can slow down and sometimes reverse the more severe cases of the condition. Diagnostic tools can catch it in its early stages.To check for it, "We dilate your eyes, use a lens and look for yellow spots (drusen) or pigmentation changes or bleeding," says Dr. Yuguang He, associate professor of ophthalmology at the University of Texas Southwestern Medical Center and a specialist in age-related macular degeneration. "It's not like it takes a blood test or X-ray to diagnose. We just look at it."
The sooner it's found, the better, he says. "There is a window in which we can do treatments."Most treatments are geared toward the more advanced form called wet macular degeneration. The early stage is called dry, which can progress to late-severe dry and sometimes lead to wet.Progression from the dry form to wet can be rapid. Tyler went to a doctor when she first had symptoms, so he was able to diagnose the disease early. Thus, she's been able to receive a relatively new and often successful treatment: a monthly shot directly into each of her eyes."It's psychologically and emotionally very draining," says Tyler, whose father has the dry variety of the disease.
The shot, explains Csaky, her doctor, inhibits a protein responsible for blood vessels growing and bleeding under the retina."We're not curing the disease," he says. "We're inhibiting, with a drug, a protein that's constantly being made, and with the injection it disappears for four to six weeks. The blood vessels are still there in a dormant state. If you don't treat them, they start to grow back."It's not comfortable, but patients tolerate it well, he says, though occasionally "we have a loved one faint who's watching. We use a topical anesthetic and a very, very small needle."
Although there is no surefire way to prevent the disease, studies have shown that eating fish two or more times per week helps reduce the risk, he says. "I take fish oil. I'm 54 years old and take it not only to prevent AMD but also to protect my heart, help my cholesterol. I tell patients, something good for your heart has to be good for your eyes."He also points out the Age-Related Eye Disease study of the National Eye Institution. Participants took large quantities of vitamins A and C, as well as zinc, copper and beta carotene. The regimen neither prevents the disease nor, in the study, did it have any effect on the dry form, but it "slowed the progression of the wet variety by 20 percent," he says.
Tyler, who declined to give her age, manages her ailment as best she can, getting injections and participating in a study. She is constantly aware of her surroundings, on the lookout for any line in a grid that appears curvy or wavy. She checks the spindles on her staircase, "whatever's around me," for possible distortion."It was never even in my mind, as driven and focused as I am in my career, that I wouldn't be responsive to it," she says. "It's your vision for heaven's sake. How scary is that?
"You can work with it and make it a positive thing, or it can devastate you. You make these choices in life. What am I going to do about it? Is it going to define me, or am I going to help define it?"Age-related macular degeneration (AMD) is the No. 1 cause of irreversible vision loss among senior citizens, according to the Retina Foundation of the Southwest. Some risk factors:
Caucasians are more likely to contract AMD than other races."If you're a Caucasian older than 65, there's a 20 percent chance you'll get it," says Dr. Yuguang He, associate professor of ophthalmology at UT Southwestern Medical Center. "If you're Chinese or Japanese, less than 5 percent. African-Americans have it much less than Caucasians."Yet, "as the Japanese adopted our diet, their incidence has gone up," says Dr. Karl Csaky of the Retina Foundation of the Southwest and Texas Retina Associates.
Smoking increases incidence."Cigarette smokers are 20 times more likely to develop AMD than nonsmokers," he says. "The chances are very, very high."
If one eye is affected, the other eye will be, too.It's important to periodically cover up the eye that has it to see whether the other eye is seeing distortions, too.Genetics play a factor."If your parents have it, there's an increased risk you'll get it, but it's not a guarantee," he says. "We're still struggling with the practical implications of these genetic associations other than scaring people."
Showing posts with label blind. Show all posts
Showing posts with label blind. Show all posts
Sunday, January 23, 2011
Sunday, January 2, 2011
Case Western Reserve receives $10 million to study Retina Disease
by: Jessica Studeny
The Departments of Pharmacology and Ophthalmology and Visual Sciences at Case Western Reserve University School of Medicine have been awarded a $10.1 million grant from the National Eye Institute (NEI) to research and develop new treatments for diseases of the retina, a leading cause of blindness.
"The grant strongly positions the School of Medicine and collaborating organizations to play a significant role in advancing the treatment of retinal diseases in order to restore quality of life to countless patients," said Jonathan H. Lass, MD, professor and chair of the Department of Ophthalmology and Visual Sciences at Case Western Reserve School of Medicine and director of the University Hospitals Eye Institute. "It is the largest grant of its kind ever awarded to the university by the National Eye Institute, a tremendous achievement."
The NEI, part of the National Institutes of Health (NIH), will award the grant over five years, funding the work of researchers in the Departments of Pharmacology, Ophthalmology, and Biomedical Engineering at the School of Medicine who are working in collaboration with the Retinal Therapeutics Study Group. This interdisciplinary consortium of investigators is screening FDA-approved drugs for their potential application to the treatment of eye diseases affecting the retina.
The combined group, which also includes researchers from the Cincinnati Drug Discovery Center, the University of Pennsylvania and Washington University, aims to accelerate the rate at which basic science discoveries are used to develop new therapies for complex retinal disorders and diseases.
Conditions affecting the retina, the tissue in back of the eye responsible for vision, are a primary cause of blindness in adults in the United States. Such diseases include age-related macular degeneration (AMD), the main cause of blindness in adults over the age of 55. More than 1.3 million people in the U.S. are legally blind and 8 to 10 million aging individuals show signs of developing AMD, an incurable eye disease characterized by damage to the retina and the loss of central daylight vision.
"The research being funded by the NIH is critical to availing patients of new, more effective treatments, particularly for diseases like AMD, for which there is currently no cure," says Krzysztof Palczewski, PhD, John H. Hord Professor, chair of the Department of Pharmacology, and principal investigator and director of the research funded by the new NEI grant. "Our goal is to develop new drugs based on the screening of FDA-approved drugs to evaluate their effectiveness in treating retinal diseases."
Researchers will employ a range of scientific expertise and state-of-the-art physiological, chemical and analytical imaging technologies to test potential retinal disease therapies in basic research models. A non-invasive imaging technology developed at Case Western Reserve by Dr. Palczewski's research group will facilitate monitoring of the retina to detect molecular changes, defects, or harmful toxins in the retina.
FDA-approved drugs will be screened for their potential application in research models engineered to mimic conditions such as AMD, Stargardt's disease (a form of inherited juvenile macular degeneration) and retinitis pigmentosa (a group of inherited retinal disorders characterized by progressive peripheral vision loss). The drug-screening process is designed to accelerate the process of drug development before clinical testing in humans.
Dr. Palczewski is working with researcher Akiko Maeda, MD, PhD, senior instructor in the Departments of Ophthalmology and Pharmacology; and Zheng-Rong Lu, PhD, professor of biomedical engineering; to hone in on existing drugs with chemical properties and initial research results that suggest they may provide a basis for developing new drugs for treating retinal diseases like AMD.
The research builds upon previous work in Dr. Palczewski's laboratory which identified mechanisms in the eye responsible for metabolizing vitamin A, an essential step in triggering the nerve signals sent to the brain to enable vision. Researchers determined that in healthy patients, this visual cycle operates rapidly. However, in older patients and those with AMD and Stargardt-like diseases, one of the critical biochemical reactions in the series that recycle vitamin A is slowed. This allows a toxic byproduct produced by the breakdown of vitamin A to accumulate, which damages the retina over time, probably contributing to the development of AMD and/or impairing vision.
The combined teams in Ophthalmology and Pharmacology are now looking for drugs that can target the mechanism that captures toxic vitamin A metabolites, to neutralize and counter the build-up of any visual cycle toxic byproduct, as a means of preventing or controlling retinal diseases. "Current treatments for AMD focus on management of the late stages of the disease. These studies could result in treatments at the earlier stages and save more vision as a result" says Dr. Lass.
In addition to testing existing FDA-approved drugs for their ability to reduce toxic substances within the retina, priorities for the NIH-funded research also include evaluating existing FDA-approved drugs as potential lead compounds for retinal diseases because these drugs have already been proven safe and effective in basic research and clinical studies for other indications. Researchers will likewise assess the ability of potential compounds to penetrate and remain in the eye without negatively affecting vision and they will explore and develop new drug delivery systems to achieve and maintain therapeutic drug concentrations in the eye.
"We have an idea as to what drugs could be most effective for our purposes," said Dr. Maeda, who relocated from Japan to the United States to work with Dr. Palczewski. She is the study's co-principal investigator and a group leader who is responsible for basic research models. "During my clinical practice in ophthalmology, I was very frustrated with the lack of treatment options for many patients with retinal degenerative diseases, and I became determined to dedicate myself to developing new treatments for these patients through basic science research. I am very excited to develop our ideas for treating currently incurable retinal diseases."
Dr. Palczewski and his team have already examined 24 FDA-approved drugs, from antibiotics to drugs fighting cancer and infectious diseases, for their ability to attack the buildup of harmful toxins in the retina. These studies were done with mice that were genetically engineered to mimic Stargardt's disease. At least 16 of the drugs tested have already demonstrated the potential to limit the progression of retinal diseases. The resulting data provided the basis for funding the $10 million NIH grant request.
About Case Western Reserve University School of Medicine
Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the school of medicine.
Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 20 among U.S. research-oriented medical schools as designated by U.S. News & World Report "Guide to Graduate Education."
The School of Medicine's primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002.
The Departments of Pharmacology and Ophthalmology and Visual Sciences at Case Western Reserve University School of Medicine have been awarded a $10.1 million grant from the National Eye Institute (NEI) to research and develop new treatments for diseases of the retina, a leading cause of blindness.
"The grant strongly positions the School of Medicine and collaborating organizations to play a significant role in advancing the treatment of retinal diseases in order to restore quality of life to countless patients," said Jonathan H. Lass, MD, professor and chair of the Department of Ophthalmology and Visual Sciences at Case Western Reserve School of Medicine and director of the University Hospitals Eye Institute. "It is the largest grant of its kind ever awarded to the university by the National Eye Institute, a tremendous achievement."
The NEI, part of the National Institutes of Health (NIH), will award the grant over five years, funding the work of researchers in the Departments of Pharmacology, Ophthalmology, and Biomedical Engineering at the School of Medicine who are working in collaboration with the Retinal Therapeutics Study Group. This interdisciplinary consortium of investigators is screening FDA-approved drugs for their potential application to the treatment of eye diseases affecting the retina.
The combined group, which also includes researchers from the Cincinnati Drug Discovery Center, the University of Pennsylvania and Washington University, aims to accelerate the rate at which basic science discoveries are used to develop new therapies for complex retinal disorders and diseases.
Conditions affecting the retina, the tissue in back of the eye responsible for vision, are a primary cause of blindness in adults in the United States. Such diseases include age-related macular degeneration (AMD), the main cause of blindness in adults over the age of 55. More than 1.3 million people in the U.S. are legally blind and 8 to 10 million aging individuals show signs of developing AMD, an incurable eye disease characterized by damage to the retina and the loss of central daylight vision.
"The research being funded by the NIH is critical to availing patients of new, more effective treatments, particularly for diseases like AMD, for which there is currently no cure," says Krzysztof Palczewski, PhD, John H. Hord Professor, chair of the Department of Pharmacology, and principal investigator and director of the research funded by the new NEI grant. "Our goal is to develop new drugs based on the screening of FDA-approved drugs to evaluate their effectiveness in treating retinal diseases."
Researchers will employ a range of scientific expertise and state-of-the-art physiological, chemical and analytical imaging technologies to test potential retinal disease therapies in basic research models. A non-invasive imaging technology developed at Case Western Reserve by Dr. Palczewski's research group will facilitate monitoring of the retina to detect molecular changes, defects, or harmful toxins in the retina.
FDA-approved drugs will be screened for their potential application in research models engineered to mimic conditions such as AMD, Stargardt's disease (a form of inherited juvenile macular degeneration) and retinitis pigmentosa (a group of inherited retinal disorders characterized by progressive peripheral vision loss). The drug-screening process is designed to accelerate the process of drug development before clinical testing in humans.
Dr. Palczewski is working with researcher Akiko Maeda, MD, PhD, senior instructor in the Departments of Ophthalmology and Pharmacology; and Zheng-Rong Lu, PhD, professor of biomedical engineering; to hone in on existing drugs with chemical properties and initial research results that suggest they may provide a basis for developing new drugs for treating retinal diseases like AMD.
The research builds upon previous work in Dr. Palczewski's laboratory which identified mechanisms in the eye responsible for metabolizing vitamin A, an essential step in triggering the nerve signals sent to the brain to enable vision. Researchers determined that in healthy patients, this visual cycle operates rapidly. However, in older patients and those with AMD and Stargardt-like diseases, one of the critical biochemical reactions in the series that recycle vitamin A is slowed. This allows a toxic byproduct produced by the breakdown of vitamin A to accumulate, which damages the retina over time, probably contributing to the development of AMD and/or impairing vision.
The combined teams in Ophthalmology and Pharmacology are now looking for drugs that can target the mechanism that captures toxic vitamin A metabolites, to neutralize and counter the build-up of any visual cycle toxic byproduct, as a means of preventing or controlling retinal diseases. "Current treatments for AMD focus on management of the late stages of the disease. These studies could result in treatments at the earlier stages and save more vision as a result" says Dr. Lass.
In addition to testing existing FDA-approved drugs for their ability to reduce toxic substances within the retina, priorities for the NIH-funded research also include evaluating existing FDA-approved drugs as potential lead compounds for retinal diseases because these drugs have already been proven safe and effective in basic research and clinical studies for other indications. Researchers will likewise assess the ability of potential compounds to penetrate and remain in the eye without negatively affecting vision and they will explore and develop new drug delivery systems to achieve and maintain therapeutic drug concentrations in the eye.
"We have an idea as to what drugs could be most effective for our purposes," said Dr. Maeda, who relocated from Japan to the United States to work with Dr. Palczewski. She is the study's co-principal investigator and a group leader who is responsible for basic research models. "During my clinical practice in ophthalmology, I was very frustrated with the lack of treatment options for many patients with retinal degenerative diseases, and I became determined to dedicate myself to developing new treatments for these patients through basic science research. I am very excited to develop our ideas for treating currently incurable retinal diseases."
Dr. Palczewski and his team have already examined 24 FDA-approved drugs, from antibiotics to drugs fighting cancer and infectious diseases, for their ability to attack the buildup of harmful toxins in the retina. These studies were done with mice that were genetically engineered to mimic Stargardt's disease. At least 16 of the drugs tested have already demonstrated the potential to limit the progression of retinal diseases. The resulting data provided the basis for funding the $10 million NIH grant request.
About Case Western Reserve University School of Medicine
Founded in 1843, Case Western Reserve University School of Medicine is the largest medical research institution in Ohio and is among the nation's top medical schools for research funding from the National Institutes of Health. The School of Medicine is recognized throughout the international medical community for outstanding achievements in teaching. The School's innovative and pioneering Western Reserve2 curriculum interweaves four themes--research and scholarship, clinical mastery, leadership, and civic professionalism--to prepare students for the practice of evidence-based medicine in the rapidly changing health care environment of the 21st century. Nine Nobel Laureates have been affiliated with the school of medicine.
Annually, the School of Medicine trains more than 800 MD and MD/PhD students and ranks in the top 20 among U.S. research-oriented medical schools as designated by U.S. News & World Report "Guide to Graduate Education."
The School of Medicine's primary affiliate is University Hospitals Case Medical Center and is additionally affiliated with MetroHealth Medical Center, the Louis Stokes Cleveland Department of Veterans Affairs Medical Center, and the Cleveland Clinic, with which it established the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in 2002.
Monday, December 27, 2010
Age-Related Macular Degeneration Research from University of Bristol
by: University
"Neovascular age-related macular degeneration (nvAMD) is a chronic, progressive disease of the central retina, and its prevalence is expected to rise with the aging population. Using a bottom-up approach based on retrospective data, this cross-sectional study estimated average annual direct costs of nvAMD to be A 4,047 pound, and average annual indirect costs to be A 449 pound," scientists in Bristol, the United Kingdom report.
"An attempt to measure intangible costs through willingness-to-pay yielded a lower response rate and estimated intangible costs to be 11.5% of monthly income. Direct costs were significantly higher for male participants, for those who have mild or moderate visual impairment in both eyes, and for those who have been diagnosed for a shorter time," wrote K.M. Ke and colleagues, University of Bristol.
The researchers concluded: "The findings of this study suggest that the availability of early diagnosis, effective treatment, support services, and sustained research into the management of nvAMD may reduce the burden of visual impairment caused by nvAMD to affected individuals and the state."
Ke and colleagues published their study in European Journal of Health Economics (The direct, indirect and intangible costs of visual impairment caused by neovascular age-related macular degeneration. European Journal of Health Economics, 2010;11(6):525-531).
For additional information, contact K.M. Ke, University of Bristol, Bristol Dental School, Dept. of Oral & Dental Science, Lower Maudlin St., Bristol BS1 2LY, Avon, UK.
The publisher's contact information for the European Journal of Health Economics is: Springer, 233 Spring St., New York, NY 10013, USA.
Keywords: City:Bristol, Country:United Kingdom, Age-Related Macular Degeneration, Retinal Degeneration, Retinal Diseases
"Neovascular age-related macular degeneration (nvAMD) is a chronic, progressive disease of the central retina, and its prevalence is expected to rise with the aging population. Using a bottom-up approach based on retrospective data, this cross-sectional study estimated average annual direct costs of nvAMD to be A 4,047 pound, and average annual indirect costs to be A 449 pound," scientists in Bristol, the United Kingdom report.
"An attempt to measure intangible costs through willingness-to-pay yielded a lower response rate and estimated intangible costs to be 11.5% of monthly income. Direct costs were significantly higher for male participants, for those who have mild or moderate visual impairment in both eyes, and for those who have been diagnosed for a shorter time," wrote K.M. Ke and colleagues, University of Bristol.
The researchers concluded: "The findings of this study suggest that the availability of early diagnosis, effective treatment, support services, and sustained research into the management of nvAMD may reduce the burden of visual impairment caused by nvAMD to affected individuals and the state."
Ke and colleagues published their study in European Journal of Health Economics (The direct, indirect and intangible costs of visual impairment caused by neovascular age-related macular degeneration. European Journal of Health Economics, 2010;11(6):525-531).
For additional information, contact K.M. Ke, University of Bristol, Bristol Dental School, Dept. of Oral & Dental Science, Lower Maudlin St., Bristol BS1 2LY, Avon, UK.
The publisher's contact information for the European Journal of Health Economics is: Springer, 233 Spring St., New York, NY 10013, USA.
Keywords: City:Bristol, Country:United Kingdom, Age-Related Macular Degeneration, Retinal Degeneration, Retinal Diseases
Monday, December 20, 2010
Genetic Testing for AMD is here Today
by:Diana Shechtman OD FAAO & Steven Ferrucci OD FAAO
Age-Related macular degeneration (AMD) is a progressive disease and the leading cause of vision loss among the elderly, affecting central vision required for daily activities such as driving and reading. There are a number of factors affecting AMD, such as advanced age, smoking, UV exposure, overall health (that contribute to high blood pressure, obesity, diet) and family history. Many factors may be modified and yet others like genetics cannot. Although AMD may seem to be hereditary in some families and not others, genetics have been shown to contribute significantly to the disease. Multiple twin and sibling studies have collaborated to the familial nature of the disease. First-degree relatives of patients with AMD are at a significantly increased risk for the disease. Furthermore, large epidemiological studies have suggested a strong genetic risk factor for AMD. In fact, the risk of developing AMD increases 4 fold among patients with a positive family history. In 2005 a breakthrough occurred in the area of genetic research and AMD; Klein and associates discovered a strong link between AMD and certain genetic variants. Similarly, numerous other genes have been implicated in AMD, which may increase the risk of AMD up to 70%.
Until recently there was no test to help determined patient’s inherited risk for AMD. Today, Macula Risk (ArcticDX, Toronto, Ontario) is a genetic test specifically designed to determine genetic predisposition to AMD and vision loss attributed to the more advanced stage of the disease.
Macula Risk genetic test separates individuals into one of 5 macula risk (MR) categories, with MR 3 through 5 representing an increased risk for the more advance stage of the disease. This accounts for approximately 20% of the general population. MR1 has less than a 5% risk of the advanced stage of the disease, while MR 5 carries greater than 55% risk. These results can aid the doctor in devising a specific management plan and follow-up protocol in order to reassure early intervention to prevent vision loss.
The test only requires a simple in-office cheek swab, which is sent directly to the genetic lab. The report includes test results and written genetic support information (including access to genetic counseling). Macula Risk genetic testing is covered by most insurance providers, including Medicare, as long as the specific diagnosis (ICD-9) are identified by the doctor. The prognostic genetic test is intended for patients who have a diagnosis of early or intermediate AMD. Thus, the “at risk patient,” would have to pay a fee for the test.
Despite our best efforts and new treatment options available today, many people are still losing vision from AMD. New advancements in the area of AMD are becoming an integral part in preventing future visual deterioration. AMD is affected by both environmental and genetic factors that interact with one another to determine prevalence and progression of the disease. Furthermore, at this time we do not know all of the genes linked to AMD. Hence, genetic testing in the area of AMD is only a risk indicator and cannot predict “without a shadow of a doubt,” which patients will and which will not develop the disease. However, this test provides a genetic profile screening to help identify those at risk as well as aids in tailoring a distinct management approach for those with the disease. With various researches devoted to treatment options for AMD, genetic testing in the area of AMD is at the frontier of providing crucial information.
REFERENCES
1. Swaroop, Branham KE, Chen W, Abecasis G. Genetic susceptibility to age-related macular degeneration: a paradigm for dissecting complex disease traits. Hum Mol Genet 2007; 16: 174-82.
2. Klein ML, Mauldin WM, Stoumbos VD. Heredity and age-related macular degeneration. Observations in monozygotic twins. Arch Ophthalmol. 1994; 112: 932-7.
3. Meyers SM, Greene T, Gutman FA. A twin study of age-related macular degeneration. Am J Ophthalmol. 1995; 120: 757-66.
4. Heiba IM, Elston RC, Klein BE, et al. Sibling correlations and segregation analysis of age-related maculopathy: The Beaver Dam Eye Study. Genet Epidemiol. 1994; 11: 51-67.
5. Klaver CC, Wolfs RC, Assink JJ, et al. Genetic risk of age-related maculopathy. Population-based familial aggregation study. Arch Ophthalmol. 1998; 116: 1646-51.
6. Seddon JM, Ajani UA, Mitchell BD. Familial aggregation of age-related maculopathy. Am J Ophthalmol. 1997; 123: 199-206.
7. Klein RJ, Zeiss C, Chew EY, et al. Complement Factor H Polymorphism in Age-Related Macular Degeneration. Science 2005; 308: 385-389.
8. Seddon JM, Reynolds R, Maller J, Fagerness JA, Daly MJ, Rosner B. Prediction model for prevalence and incidence of advanced age-related macular degeneration based on genetic, demographic, and environmental variables. Invest Ophthalmol Vis Sci 2009; 50 (65): 2044-53.
9. www.macularisk.com/en/physicians/order.html (accessed Dec. 14th , 2010)
Age-Related macular degeneration (AMD) is a progressive disease and the leading cause of vision loss among the elderly, affecting central vision required for daily activities such as driving and reading. There are a number of factors affecting AMD, such as advanced age, smoking, UV exposure, overall health (that contribute to high blood pressure, obesity, diet) and family history. Many factors may be modified and yet others like genetics cannot. Although AMD may seem to be hereditary in some families and not others, genetics have been shown to contribute significantly to the disease. Multiple twin and sibling studies have collaborated to the familial nature of the disease. First-degree relatives of patients with AMD are at a significantly increased risk for the disease. Furthermore, large epidemiological studies have suggested a strong genetic risk factor for AMD. In fact, the risk of developing AMD increases 4 fold among patients with a positive family history. In 2005 a breakthrough occurred in the area of genetic research and AMD; Klein and associates discovered a strong link between AMD and certain genetic variants. Similarly, numerous other genes have been implicated in AMD, which may increase the risk of AMD up to 70%.
Until recently there was no test to help determined patient’s inherited risk for AMD. Today, Macula Risk (ArcticDX, Toronto, Ontario) is a genetic test specifically designed to determine genetic predisposition to AMD and vision loss attributed to the more advanced stage of the disease.
Macula Risk genetic test separates individuals into one of 5 macula risk (MR) categories, with MR 3 through 5 representing an increased risk for the more advance stage of the disease. This accounts for approximately 20% of the general population. MR1 has less than a 5% risk of the advanced stage of the disease, while MR 5 carries greater than 55% risk. These results can aid the doctor in devising a specific management plan and follow-up protocol in order to reassure early intervention to prevent vision loss.
The test only requires a simple in-office cheek swab, which is sent directly to the genetic lab. The report includes test results and written genetic support information (including access to genetic counseling). Macula Risk genetic testing is covered by most insurance providers, including Medicare, as long as the specific diagnosis (ICD-9) are identified by the doctor. The prognostic genetic test is intended for patients who have a diagnosis of early or intermediate AMD. Thus, the “at risk patient,” would have to pay a fee for the test.
Despite our best efforts and new treatment options available today, many people are still losing vision from AMD. New advancements in the area of AMD are becoming an integral part in preventing future visual deterioration. AMD is affected by both environmental and genetic factors that interact with one another to determine prevalence and progression of the disease. Furthermore, at this time we do not know all of the genes linked to AMD. Hence, genetic testing in the area of AMD is only a risk indicator and cannot predict “without a shadow of a doubt,” which patients will and which will not develop the disease. However, this test provides a genetic profile screening to help identify those at risk as well as aids in tailoring a distinct management approach for those with the disease. With various researches devoted to treatment options for AMD, genetic testing in the area of AMD is at the frontier of providing crucial information.
REFERENCES
1. Swaroop, Branham KE, Chen W, Abecasis G. Genetic susceptibility to age-related macular degeneration: a paradigm for dissecting complex disease traits. Hum Mol Genet 2007; 16: 174-82.
2. Klein ML, Mauldin WM, Stoumbos VD. Heredity and age-related macular degeneration. Observations in monozygotic twins. Arch Ophthalmol. 1994; 112: 932-7.
3. Meyers SM, Greene T, Gutman FA. A twin study of age-related macular degeneration. Am J Ophthalmol. 1995; 120: 757-66.
4. Heiba IM, Elston RC, Klein BE, et al. Sibling correlations and segregation analysis of age-related maculopathy: The Beaver Dam Eye Study. Genet Epidemiol. 1994; 11: 51-67.
5. Klaver CC, Wolfs RC, Assink JJ, et al. Genetic risk of age-related maculopathy. Population-based familial aggregation study. Arch Ophthalmol. 1998; 116: 1646-51.
6. Seddon JM, Ajani UA, Mitchell BD. Familial aggregation of age-related maculopathy. Am J Ophthalmol. 1997; 123: 199-206.
7. Klein RJ, Zeiss C, Chew EY, et al. Complement Factor H Polymorphism in Age-Related Macular Degeneration. Science 2005; 308: 385-389.
8. Seddon JM, Reynolds R, Maller J, Fagerness JA, Daly MJ, Rosner B. Prediction model for prevalence and incidence of advanced age-related macular degeneration based on genetic, demographic, and environmental variables. Invest Ophthalmol Vis Sci 2009; 50 (65): 2044-53.
9. www.macularisk.com/en/physicians/order.html (accessed Dec. 14th , 2010)
Sunday, November 28, 2010
DeGette Hails Approval of Second Embryonic Stem Cell Human Trial
by:PoliticalNews
Congresswoman Diana DeGette (CO-01) hailed the approval of the second human treatment trial using human embryonic stem cells. The test, just approved by the FDA, will be conducted by Advanced Cell Technology (ACT) and will focus on Stagart disease. Medical professionals believe a successful human trial will open the doors to the treatment of other, more common eye diseases such as macular degeneration. DeGette has been the leading Congressional advocate for federal funding of ethical embryonic stem cell research, as these investments drive breakthrough trials like the one announced this week.
“Embryonic stem cell research holds enormous promise for countless diseases,” said DeGette, “and the approval of this test is yet another step towards the breakthroughs it can bring for millions of Americans. I am excited to see the results of this, and other trials, and encourage my colleagues to recognize the enormous benefits of ethical embryonic stem cell research.”
Stagart’s disease affects central vision – e.g., reading and facial recognition – and can cause its victims to lose peripheral vision, only be able to see various levels of light, or ultimately go blind. This test will treat Stagart’s patients with healthy cells, created from embryonic stem cells, to replace the “scavenger cells” that deteriorate their vision.
The test is the second trial using embryonic stem cells to be approved in the United States. Last month, the Geron Corporation was permitted to conduct a trial involving embryonic stem cells to treat spinal cord injuries. Preliminary testing is still ongoing in that trial. Like the Geron trial, this latest trial will focus primarily on the safety and viability of embryonic stem cell use in the treatment of this condition. The Stagart’s trial will likely start early next year and 12 subjects will be treated.
“The approval of these two tests in such close order demonstrates how the investment by the federal government in ethical stem cell research is beginning to bear fruit for the millions of Americans facing debilitating diseases and conditions,” said DeGette. “The breakthroughs of these discoveries underscore the critical importance of finally codifying ethical stem cell research regulations, so our scientists and their critical work can no longer be subject to political whims.”
Congresswoman Diana DeGette (CO-01) hailed the approval of the second human treatment trial using human embryonic stem cells. The test, just approved by the FDA, will be conducted by Advanced Cell Technology (ACT) and will focus on Stagart disease. Medical professionals believe a successful human trial will open the doors to the treatment of other, more common eye diseases such as macular degeneration. DeGette has been the leading Congressional advocate for federal funding of ethical embryonic stem cell research, as these investments drive breakthrough trials like the one announced this week.
“Embryonic stem cell research holds enormous promise for countless diseases,” said DeGette, “and the approval of this test is yet another step towards the breakthroughs it can bring for millions of Americans. I am excited to see the results of this, and other trials, and encourage my colleagues to recognize the enormous benefits of ethical embryonic stem cell research.”
Stagart’s disease affects central vision – e.g., reading and facial recognition – and can cause its victims to lose peripheral vision, only be able to see various levels of light, or ultimately go blind. This test will treat Stagart’s patients with healthy cells, created from embryonic stem cells, to replace the “scavenger cells” that deteriorate their vision.
The test is the second trial using embryonic stem cells to be approved in the United States. Last month, the Geron Corporation was permitted to conduct a trial involving embryonic stem cells to treat spinal cord injuries. Preliminary testing is still ongoing in that trial. Like the Geron trial, this latest trial will focus primarily on the safety and viability of embryonic stem cell use in the treatment of this condition. The Stagart’s trial will likely start early next year and 12 subjects will be treated.
“The approval of these two tests in such close order demonstrates how the investment by the federal government in ethical stem cell research is beginning to bear fruit for the millions of Americans facing debilitating diseases and conditions,” said DeGette. “The breakthroughs of these discoveries underscore the critical importance of finally codifying ethical stem cell research regulations, so our scientists and their critical work can no longer be subject to political whims.”
Monday, November 22, 2010
Chardan Capital Market Initiates Research Coverage of Stemcells
by GlobeNewswire
PALO ALTO, Calif., - StemCells, Inc. /quotes/comstock/15*!stem/quotes/nls/stem (STEM 1.12, -0.02, -1.75%) announced today that Chardan Capital Markets (Chardan) initiated independent equity research coverage on the Company with a "Buy" recommendation and a 12-month price target of $1.45 per share. The new report, issued yesterday, was authored by Keay Nakae, Senior Analyst at Chardan.
Chardan is the second firm to initiate independent equity research coverage of StemCells, Inc. this year. Headquartered in New York, Chardan is an investment banking and institutional brokerage firm with a focus on micro, small, and mid-cap markets. More information about Chardan is available at www.chardancm.com. StemCells does not endorse or adopt the reports, projections or statements of any analyst.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. In its therapeutic product development programs, StemCells is targeting disorders of the central nervous system and the liver. StemCells' lead product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in clinical development for the treatment of two fatal neurodegenerative disorders in children, and in preclinical development for spinal cord injury and retinal disorders such as age-related macular degeneration. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and drug development. Further information about StemCells is available at www.stemcellsinc.com.
PALO ALTO, Calif., - StemCells, Inc. /quotes/comstock/15*!stem/quotes/nls/stem (STEM 1.12, -0.02, -1.75%) announced today that Chardan Capital Markets (Chardan) initiated independent equity research coverage on the Company with a "Buy" recommendation and a 12-month price target of $1.45 per share. The new report, issued yesterday, was authored by Keay Nakae, Senior Analyst at Chardan.
Chardan is the second firm to initiate independent equity research coverage of StemCells, Inc. this year. Headquartered in New York, Chardan is an investment banking and institutional brokerage firm with a focus on micro, small, and mid-cap markets. More information about Chardan is available at www.chardancm.com. StemCells does not endorse or adopt the reports, projections or statements of any analyst.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. In its therapeutic product development programs, StemCells is targeting disorders of the central nervous system and the liver. StemCells' lead product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in clinical development for the treatment of two fatal neurodegenerative disorders in children, and in preclinical development for spinal cord injury and retinal disorders such as age-related macular degeneration. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and drug development. Further information about StemCells is available at www.stemcellsinc.com.
Monday, November 15, 2010
UC Santa Barbara Part of International Research Collaboration Focusing on Age-Related Macular degeneration Cure
By AScribe Newswire
SANTA BARBARA, Calif., Nov. 15 - An international collaboration between UC Santa Barbara, the Keck School of Medicine of the University of Southern California (USC), and several other research institutions, is bringing together leaders in the fields of stem cell biology, basic science, and ophthalmology to develop a treatment for blindness caused by age-related macular degeneration.
The California Project to Cure Blindness (CPCB) was formed with a $16 million California Institute for Regenerative Medicine (CIRM) "disease team" grant awarded in late 2009 to fund development of a stem cell-based treatment for age-related macular degeneration. As part of the CIRM Disease Team partnership program, an additional $4.1 million from Britain's Medical Research Council funds collaborative work at University College of London.
"UCSB scientists in the Center for Stem Cell Biology and Engineering and the Center for the Study of Macular Degeneration are excited to provide the basic research that will allow translation of stem cell research to the clinic," said Dennis Clegg, professor in UCSB's Department of Molecular, Cellular, and Developmental Biology, and co-director of the UCSB Center for Stem Cell Biology and Engineering. Both centers are part of UCSB's Neuroscience Research Institute. Grant funds totaling $2.5 million for this work were assigned to UCSB through USC.
The overall grant was awarded to principal investigator Mark Humayun, professor of ophthalmology, cell and neurobiology and biomedical engineering at the Keck School, and David R. Hinton, professor of pathology and ophthalmology at the Keck School. Co-investigator is Martin Pera, director of the Eli and Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC.
"With this collaboration, we hope to accelerate research on a stem cell-based therapy for age-related macular degeneration," said Humayun. "Age-related macular degeneration is the leading cause of irreversible vision loss, affecting one in three people age 75 or older. The CIRM grant enables us to work with numerous researchers and experts who are dedicated to finding the cure to this devastating medical condition."
The cause of blindness in age-related macular degeneration is the death of retinal pigment epithelial cells, which provide critical support of photoreceptor function and health. The project objective is to replace damaged retinal epithelium with healthy tissue derived from human embryonic stem cells to prevent loss of vision.
Stem cell therapy offers the possibility of a wider range of options for age-related macular degeneration patients, said Keck School Dean Carmen A. Puliafito. "While exciting new pharmaceuticals to treat age-related macular degeneration are now available, these are effective only in a select group of patients, and can be used only during a narrow time window," said Puliafito, an ophthalmologist whose academic focus is macular degeneration. "In contrast, stem cell therapy promises to be broadly applicable. The potential is tremendous."
CIRM President Alan Trounson noted that the disease team approach exemplified by the California Project to Cure Blindness could transform the direction of future research.
"Scientists have talked for years about the need to find ways to speed the pace of discovery," said Trounson. "CIRM, through the Disease Team Award Program, has encouraged applicants to form teams composed of the best researchers from around the world. The partnership between the California Project to Cure Blindness and Britain's Medical Research Council is a great example of CIRM's vision of a new standard for funding translational research."
SANTA BARBARA, Calif., Nov. 15 - An international collaboration between UC Santa Barbara, the Keck School of Medicine of the University of Southern California (USC), and several other research institutions, is bringing together leaders in the fields of stem cell biology, basic science, and ophthalmology to develop a treatment for blindness caused by age-related macular degeneration.
The California Project to Cure Blindness (CPCB) was formed with a $16 million California Institute for Regenerative Medicine (CIRM) "disease team" grant awarded in late 2009 to fund development of a stem cell-based treatment for age-related macular degeneration. As part of the CIRM Disease Team partnership program, an additional $4.1 million from Britain's Medical Research Council funds collaborative work at University College of London.
"UCSB scientists in the Center for Stem Cell Biology and Engineering and the Center for the Study of Macular Degeneration are excited to provide the basic research that will allow translation of stem cell research to the clinic," said Dennis Clegg, professor in UCSB's Department of Molecular, Cellular, and Developmental Biology, and co-director of the UCSB Center for Stem Cell Biology and Engineering. Both centers are part of UCSB's Neuroscience Research Institute. Grant funds totaling $2.5 million for this work were assigned to UCSB through USC.
The overall grant was awarded to principal investigator Mark Humayun, professor of ophthalmology, cell and neurobiology and biomedical engineering at the Keck School, and David R. Hinton, professor of pathology and ophthalmology at the Keck School. Co-investigator is Martin Pera, director of the Eli and Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell Research at USC.
"With this collaboration, we hope to accelerate research on a stem cell-based therapy for age-related macular degeneration," said Humayun. "Age-related macular degeneration is the leading cause of irreversible vision loss, affecting one in three people age 75 or older. The CIRM grant enables us to work with numerous researchers and experts who are dedicated to finding the cure to this devastating medical condition."
The cause of blindness in age-related macular degeneration is the death of retinal pigment epithelial cells, which provide critical support of photoreceptor function and health. The project objective is to replace damaged retinal epithelium with healthy tissue derived from human embryonic stem cells to prevent loss of vision.
Stem cell therapy offers the possibility of a wider range of options for age-related macular degeneration patients, said Keck School Dean Carmen A. Puliafito. "While exciting new pharmaceuticals to treat age-related macular degeneration are now available, these are effective only in a select group of patients, and can be used only during a narrow time window," said Puliafito, an ophthalmologist whose academic focus is macular degeneration. "In contrast, stem cell therapy promises to be broadly applicable. The potential is tremendous."
CIRM President Alan Trounson noted that the disease team approach exemplified by the California Project to Cure Blindness could transform the direction of future research.
"Scientists have talked for years about the need to find ways to speed the pace of discovery," said Trounson. "CIRM, through the Disease Team Award Program, has encouraged applicants to form teams composed of the best researchers from around the world. The partnership between the California Project to Cure Blindness and Britain's Medical Research Council is a great example of CIRM's vision of a new standard for funding translational research."
Thursday, November 4, 2010
Miracle Eye Implant Restores sight to Blind
by Victoria Fletcher
A MAN who was totally blind can now read letters of the alphabet and the time on a clock face with a microchip implanted in his eye, it was revealed yesterday.
Experts said hopes of such a leap forward had previously existed “only in the realm of science fiction”.
But now researchers have shown it is possible to restore vision lost to disease with an electronic eye.
The study, by a team in Germany, will offer hope to the 25,000 Britons who are told they will go blind due to an inherited condition known as retinitis pigmentosa.
But it could also eventually treat the 300,000 who have macular degeneration which also leads to blindness.
The microchip, smaller than the tip of a pen and containing 1,500 tiny light sensors, fits into a natural space beneath the retina.
When an image comes through the lens of the eye it hits the sensors which send an electrical pulse to nerve cells at the back of the eye. These transmit the message to the brain.
Miikka can now tell an apple from a banana and right Professor Robert Maclaren
The device is powered by a thin cable that runs from the eye, out of the side of the skull and is attached to a battery behind the ear.
The new study reveals that three patients have been able to see grainy images of objects and recognise shapes after having the device fitted.
Finn Miikka Terho, 46, was able to walk around a room with ease, read his own name and even tell researchers they had spelt it wrongly.
He could recognise shades of grey, read the time from a clock and pick up an apple and a banana from the table in front of him.
Before the implant he was totally blind apart from being able to detect changes between light and dark.
The pilot study, published in the Proceedings of the Royal Society B Journal, means the technology behind the device works, is safe and is ready to be tested on a larger number of patients in a proper clinical trial.
Although it does not mean patients will ever be able to see normally, it does raise the prospect that the blind will be helped to see enough to regain some independence.
Prof Robert Maclaren, Professor of Ophthalmology at Oxford University, will conduct the next trial.
He said: “This is a big breakthrough, no two ways about it. To take someone who is blind and help them see again is pretty incredible.”
He added: “The successful testing of this electronic implant in Germany is without doubt a truly significant advance.
“One previously blind patient was able to read his own name with the implant switched on. Until now, this concept would have been considered only in the realms of science fiction.”
In recent years, scientists have helped to restore vision using a small camera mounted on spectacles.
This allowed a rough interpretation of an image beamed through a wire into the brain.
But the new device, developed by German scientist Prof Eberhart Zrenner, shows that the damaged light receptor cells in the eye can simply be replaced by a microchip.
The rest of the image is obtained by the natural eye. Prof Zrenner has now set up the technology firm Retinal Implant AG to develop the device.
Around one in 3,000 Britons have retinitis pigmentosa, which destroys light cells in the eye.The condition, triggered by a range of genes, is incurable and untreatable.
More than 10 times as many people have macular degeneration.
It usually affects older adults and leads to a loss of central vision, making it difficult or impossible to read or recognise faces although enough some peripheral vision remains.
Prof Maclaren said he was thrilled he could now tell patients with retinitis pigmentosa that there was hope ahead after years of having to tell them they would be left completely blind. And he said that although the device did not offer an amazing quality of vision, it would be significant for people who had previously been unable to see anything.
David Head, chief executive of the British Retinitis Pigmentosa Society, welcomed the news, calling it “a very significant advance”. But he said he wanted patients to realise that even this breakthrough would not restore their vision.
He added: “The technology is exciting and hopefully this will advance in the next few years but we have to temper it with reality.”
Up to 12 patients are expected to take part in the British study, due to start early next year at King’s College Hospital, London, and the Oxford Eye Hospital.It is hoped that when the device can be left in place for years instead of months, the brain may learn to interpret the grey and white images into far more accurate pictures of what the eye is really seeing.
A MAN who was totally blind can now read letters of the alphabet and the time on a clock face with a microchip implanted in his eye, it was revealed yesterday.
Experts said hopes of such a leap forward had previously existed “only in the realm of science fiction”.
But now researchers have shown it is possible to restore vision lost to disease with an electronic eye.
The study, by a team in Germany, will offer hope to the 25,000 Britons who are told they will go blind due to an inherited condition known as retinitis pigmentosa.
But it could also eventually treat the 300,000 who have macular degeneration which also leads to blindness.
The microchip, smaller than the tip of a pen and containing 1,500 tiny light sensors, fits into a natural space beneath the retina.
When an image comes through the lens of the eye it hits the sensors which send an electrical pulse to nerve cells at the back of the eye. These transmit the message to the brain.
Miikka can now tell an apple from a banana and right Professor Robert Maclaren
The device is powered by a thin cable that runs from the eye, out of the side of the skull and is attached to a battery behind the ear.
The new study reveals that three patients have been able to see grainy images of objects and recognise shapes after having the device fitted.
Finn Miikka Terho, 46, was able to walk around a room with ease, read his own name and even tell researchers they had spelt it wrongly.
He could recognise shades of grey, read the time from a clock and pick up an apple and a banana from the table in front of him.
Before the implant he was totally blind apart from being able to detect changes between light and dark.
The pilot study, published in the Proceedings of the Royal Society B Journal, means the technology behind the device works, is safe and is ready to be tested on a larger number of patients in a proper clinical trial.
Although it does not mean patients will ever be able to see normally, it does raise the prospect that the blind will be helped to see enough to regain some independence.
Prof Robert Maclaren, Professor of Ophthalmology at Oxford University, will conduct the next trial.
He said: “This is a big breakthrough, no two ways about it. To take someone who is blind and help them see again is pretty incredible.”
He added: “The successful testing of this electronic implant in Germany is without doubt a truly significant advance.
“One previously blind patient was able to read his own name with the implant switched on. Until now, this concept would have been considered only in the realms of science fiction.”
In recent years, scientists have helped to restore vision using a small camera mounted on spectacles.
This allowed a rough interpretation of an image beamed through a wire into the brain.
But the new device, developed by German scientist Prof Eberhart Zrenner, shows that the damaged light receptor cells in the eye can simply be replaced by a microchip.
The rest of the image is obtained by the natural eye. Prof Zrenner has now set up the technology firm Retinal Implant AG to develop the device.
Around one in 3,000 Britons have retinitis pigmentosa, which destroys light cells in the eye.The condition, triggered by a range of genes, is incurable and untreatable.
More than 10 times as many people have macular degeneration.
It usually affects older adults and leads to a loss of central vision, making it difficult or impossible to read or recognise faces although enough some peripheral vision remains.
Prof Maclaren said he was thrilled he could now tell patients with retinitis pigmentosa that there was hope ahead after years of having to tell them they would be left completely blind. And he said that although the device did not offer an amazing quality of vision, it would be significant for people who had previously been unable to see anything.
David Head, chief executive of the British Retinitis Pigmentosa Society, welcomed the news, calling it “a very significant advance”. But he said he wanted patients to realise that even this breakthrough would not restore their vision.
He added: “The technology is exciting and hopefully this will advance in the next few years but we have to temper it with reality.”
Up to 12 patients are expected to take part in the British study, due to start early next year at King’s College Hospital, London, and the Oxford Eye Hospital.It is hoped that when the device can be left in place for years instead of months, the brain may learn to interpret the grey and white images into far more accurate pictures of what the eye is really seeing.
Tuesday, November 2, 2010
OGI invests in personalized medicine for age-related macular degeneration
by administrator
Established in 2007 and based in Toronto, ArcticDx has developed a test, Macula Risk®, the first of its kind and specifically designed to determine one's inherited risk for age-related macular degeneration (AMD), the most common form of acquired blindness in the developed world, affecting over 10% of individuals. ArcticDx will use the PBDF investment to undertake studies in support of a planned filing for Food and Drug Administration (FDA) approval for Macula Risk.
Macula Risk detects variations in genetic markers known to predict the progression of early asymptomatic AMD to blindness using a cheek swab sample. The eyesight of individuals who are genetically predisposed to blindness can be saved through enhanced surveillance and early treatment. Macula Risk helps target effective care to those who need it most and relieves others who would otherwise live with uncertainty.
"The investment from OGI will support our filing for FDA approval for Macula Risk," commented Mr. Gregory Hines, CEO of ArcticDx. "We think this approval is an important departure from the growing trend of direct to consumer marketing of genetic tests that have only a weak link to science and are often of no clinical value. Macula Risk stands as the best example of a validated test for a multi-genetic common human disease. Achieving FDA approval will position Macula Risk for wide spread adoption."
The Macula Risk test will be marketed to eye care professionals who manage most cases of AMD in North America. These doctors will offer the test to individuals with the dry form of the disease who have not yet lost vision.
In the industrialized world, AMD is the major cause of uncorrectable vision loss in the elderly, affecting over 2.5 million people in Canada and over 25 million people in the USA. Age?related macular degeneration is generally a disease of the elderly with the worldwide incidence of the disease growing from one in ten people over the age of 60 to more than 1 in 4 people over the age of 75. Macular degeneration is more common than Parkinson's disease, Alzheimer's disease, breast cancer and prostate cancer combined.
"Application of genomics technologies is opening the door to an era of personalized medicine in our approach to preventing, detecting and treating human disease," commented Dr. Christian Burks, President and CEO, OGI. "We are particularly pleased to be investing in a company that grew out of applied research funded by Genome Canada through OGI."
The funded work will focus on a cohort of patient samples who had early stage AMD in the Age-Related Eye Disease Study (AREDS), a large eye survey carried out by the American National Eye Institute. These patients were followed over a five-year period to determine progression of the disease. The ArcticDx team will undertake a prospective study on this cohort to evaluate use of Macula Risk in predicting which patients will progress to wet AMD (the late form of AMD) and which will not.
OGI's PBDF program invests in opportunities ? based in genomics, proteomics or associated technologies ? that fall in the proof-of-principle (validation) phase of research and that have the short-term potential to secure a significant next step towards the marketplace. Previous recipients have included Ontario universities, research institutes and companies.
Established in 2007 and based in Toronto, ArcticDx has developed a test, Macula Risk®, the first of its kind and specifically designed to determine one's inherited risk for age-related macular degeneration (AMD), the most common form of acquired blindness in the developed world, affecting over 10% of individuals. ArcticDx will use the PBDF investment to undertake studies in support of a planned filing for Food and Drug Administration (FDA) approval for Macula Risk.
Macula Risk detects variations in genetic markers known to predict the progression of early asymptomatic AMD to blindness using a cheek swab sample. The eyesight of individuals who are genetically predisposed to blindness can be saved through enhanced surveillance and early treatment. Macula Risk helps target effective care to those who need it most and relieves others who would otherwise live with uncertainty.
"The investment from OGI will support our filing for FDA approval for Macula Risk," commented Mr. Gregory Hines, CEO of ArcticDx. "We think this approval is an important departure from the growing trend of direct to consumer marketing of genetic tests that have only a weak link to science and are often of no clinical value. Macula Risk stands as the best example of a validated test for a multi-genetic common human disease. Achieving FDA approval will position Macula Risk for wide spread adoption."
The Macula Risk test will be marketed to eye care professionals who manage most cases of AMD in North America. These doctors will offer the test to individuals with the dry form of the disease who have not yet lost vision.
In the industrialized world, AMD is the major cause of uncorrectable vision loss in the elderly, affecting over 2.5 million people in Canada and over 25 million people in the USA. Age?related macular degeneration is generally a disease of the elderly with the worldwide incidence of the disease growing from one in ten people over the age of 60 to more than 1 in 4 people over the age of 75. Macular degeneration is more common than Parkinson's disease, Alzheimer's disease, breast cancer and prostate cancer combined.
"Application of genomics technologies is opening the door to an era of personalized medicine in our approach to preventing, detecting and treating human disease," commented Dr. Christian Burks, President and CEO, OGI. "We are particularly pleased to be investing in a company that grew out of applied research funded by Genome Canada through OGI."
The funded work will focus on a cohort of patient samples who had early stage AMD in the Age-Related Eye Disease Study (AREDS), a large eye survey carried out by the American National Eye Institute. These patients were followed over a five-year period to determine progression of the disease. The ArcticDx team will undertake a prospective study on this cohort to evaluate use of Macula Risk in predicting which patients will progress to wet AMD (the late form of AMD) and which will not.
OGI's PBDF program invests in opportunities ? based in genomics, proteomics or associated technologies ? that fall in the proof-of-principle (validation) phase of research and that have the short-term potential to secure a significant next step towards the marketplace. Previous recipients have included Ontario universities, research institutes and companies.
Saturday, October 23, 2010
CIRM to dole Out $72M to Advance Research and Recruit Stem Cell Scientist
The California Institute for Regenerative Medicine (CIRM) approved funding for 19 awards worth $67 million under the Early Translation II Awards program. The 29-member governing board also voted to approve the second Research Leadership Award of $4.8 million, given to aid in recruiting Peter Coffey, D.Phil., from the University College London to the University of California, Santa Barbara.
The Early Translation II Awards are the second of what CIRM expects to be a 12- to 18-month award cycle for translational research grants. The funded projects are expected to either result in a candidate drug or cell therapy or make significant strides toward such a candidate.
“We are looking for ways to complement our leading edge of stem cell-based treatments for patients, and these projects will load our frontline portfolio with promising studies on autism, muscular dystrophy, Canavan disease, and liver disease,” says Alan Trounson, CIRM president.
The awards went to one for-profit and 11 not-for-profit institutions. The for-profit company iPierian will take its award in the form of a loan. Three of the awards include collaborators in Germany. The portion of the projects carried out by these collaborators will be supported by the Federal Ministry of Education and Research, the science financing agency in Germany, which will fund up to $15 million for this round of awards.
The $4.8 million grant under the Research Leadership Award program will be spread over six years and will back Dr. Coffey’s research on maturing embryonic stem cells into retinal pigment epithelial cells to treat macular degeneration and other forms of vision loss such as diabetic retinopathy and retinitis pigmentosa. Dr. Coffey is part of a team working toward a therapy for macular degeneration led by Mark Humayun, M.D., Ph.D., at the University of Southern California.
“Recruiting internationally renowned stem cell experts such as Dr. Coffey builds a critical mass of stem cell leadership in California to drive the creation of innovative therapies for patients suffering from chronic disease or injury,” notes Robert Klein, chair of the CIRM governing board.
The Early Translation II Awards are the second of what CIRM expects to be a 12- to 18-month award cycle for translational research grants. The funded projects are expected to either result in a candidate drug or cell therapy or make significant strides toward such a candidate.
“We are looking for ways to complement our leading edge of stem cell-based treatments for patients, and these projects will load our frontline portfolio with promising studies on autism, muscular dystrophy, Canavan disease, and liver disease,” says Alan Trounson, CIRM president.
The awards went to one for-profit and 11 not-for-profit institutions. The for-profit company iPierian will take its award in the form of a loan. Three of the awards include collaborators in Germany. The portion of the projects carried out by these collaborators will be supported by the Federal Ministry of Education and Research, the science financing agency in Germany, which will fund up to $15 million for this round of awards.
The $4.8 million grant under the Research Leadership Award program will be spread over six years and will back Dr. Coffey’s research on maturing embryonic stem cells into retinal pigment epithelial cells to treat macular degeneration and other forms of vision loss such as diabetic retinopathy and retinitis pigmentosa. Dr. Coffey is part of a team working toward a therapy for macular degeneration led by Mark Humayun, M.D., Ph.D., at the University of Southern California.
“Recruiting internationally renowned stem cell experts such as Dr. Coffey builds a critical mass of stem cell leadership in California to drive the creation of innovative therapies for patients suffering from chronic disease or injury,” notes Robert Klein, chair of the CIRM governing board.
Monday, October 18, 2010
Vitamin A pill could save sight
By Fiona Macrae
A drug based on vitamin A could prevent millions from going blind as they get older, doctors believe.
The treatment was able to stop the most common cause of blindness in old age during trials.
Researchers behind the drug, fenretinide, found it halted the advance of age-related macular degeneration, for which there is currently no cure.
They targeted the most prevalent form of the condition, known as ‘dry’ AMD, which is caused by the deterioration and death of cells in the macula – the part of the retina used to see straight ahead.
The disease robs sufferers of their sight by creating a blackspot in the centre of their vision.
It can make it impossible to carry out everyday tasks such as reading, driving and watching television.
While the less common ‘wet’ form can be treated, nothing can be done to help the bulk of patients.
The U.S. research studied fenretinide, which is derived from vitamin A, the vitamin found in carrots, and which was originally designed to tackle arthritis.
Almost 250 men and women with dry AMD took a fenretinide pill a day or a placebo.
In the highest dose, the drug halted visual deterioration after a year. This suggests that while it was unable to do anything to stop cells that were already damaged from dying, it protected healthy cells. Although the research is still preliminary, it offers promise of a treatment for the disease.
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It affects millions across the world and 300,000 Britons. The number of UK sufferers could more than treble to one million within 25 years as the population ages.
Dr Jason Slakter, of New York University School of Medicine, said: ‘There are currently no effective treatments for dry AMD and the need for finding one is grave.
‘Our study wasn’t designed to give a final answer.
‘It was designed to see if there was a biological effect and if the drug was working in the way we’d expect and to find out if it was well tolerated by patents.
‘I think we answered all of these points favourably. The bottom line is that I am excited about doing more studies.’
Further, larger trials are planned for the end of next year.
If the drug lives up to its initial promise, it could be in widespread use for dry AMD by 2015.
The treatment works because in normal circumstances the eye needs vitamin A to help it see. The retina naturally uses the vitamin and is helped to do so by a compound called retinol binding protein, or RBP.
However in some patients, the vitamin can produce poisons that kill the delicate cells, leading to loss of vision.
Fenretinide acts as a decoy, attaching itself to the RBP and stopping vitamin A from causing harm, the American Academy of Ophthalmology’s annual conference heard.
Wet AMD, in which tiny blood vessels bleed into the retina, is less common, but progresses more rapidly, with central vision being lost within months of diagnosis.
Caught early enough, wet AMD can be stopped in its tracks by a technique called photodynamic therapy, which uses a light-activated dye to destroy abnormal blood vessels. Drug treatments are also available.
Fenretinide also halved the odds of the patients, who already had dry AMD, going on to develop wet AMD.
A spokesman for the research team said: ‘Years of use of fenretinide to treat cancers, rheumatoid arthritis have shown it to be safe and well-tolerated.’
A drug based on vitamin A could prevent millions from going blind as they get older, doctors believe.
The treatment was able to stop the most common cause of blindness in old age during trials.
Researchers behind the drug, fenretinide, found it halted the advance of age-related macular degeneration, for which there is currently no cure.
They targeted the most prevalent form of the condition, known as ‘dry’ AMD, which is caused by the deterioration and death of cells in the macula – the part of the retina used to see straight ahead.
The disease robs sufferers of their sight by creating a blackspot in the centre of their vision.
It can make it impossible to carry out everyday tasks such as reading, driving and watching television.
While the less common ‘wet’ form can be treated, nothing can be done to help the bulk of patients.
The U.S. research studied fenretinide, which is derived from vitamin A, the vitamin found in carrots, and which was originally designed to tackle arthritis.
Almost 250 men and women with dry AMD took a fenretinide pill a day or a placebo.
In the highest dose, the drug halted visual deterioration after a year. This suggests that while it was unable to do anything to stop cells that were already damaged from dying, it protected healthy cells. Although the research is still preliminary, it offers promise of a treatment for the disease.
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It affects millions across the world and 300,000 Britons. The number of UK sufferers could more than treble to one million within 25 years as the population ages.
Dr Jason Slakter, of New York University School of Medicine, said: ‘There are currently no effective treatments for dry AMD and the need for finding one is grave.
‘Our study wasn’t designed to give a final answer.
‘It was designed to see if there was a biological effect and if the drug was working in the way we’d expect and to find out if it was well tolerated by patents.
‘I think we answered all of these points favourably. The bottom line is that I am excited about doing more studies.’
Further, larger trials are planned for the end of next year.
If the drug lives up to its initial promise, it could be in widespread use for dry AMD by 2015.
The treatment works because in normal circumstances the eye needs vitamin A to help it see. The retina naturally uses the vitamin and is helped to do so by a compound called retinol binding protein, or RBP.
However in some patients, the vitamin can produce poisons that kill the delicate cells, leading to loss of vision.
Fenretinide acts as a decoy, attaching itself to the RBP and stopping vitamin A from causing harm, the American Academy of Ophthalmology’s annual conference heard.
Wet AMD, in which tiny blood vessels bleed into the retina, is less common, but progresses more rapidly, with central vision being lost within months of diagnosis.
Caught early enough, wet AMD can be stopped in its tracks by a technique called photodynamic therapy, which uses a light-activated dye to destroy abnormal blood vessels. Drug treatments are also available.
Fenretinide also halved the odds of the patients, who already had dry AMD, going on to develop wet AMD.
A spokesman for the research team said: ‘Years of use of fenretinide to treat cancers, rheumatoid arthritis have shown it to be safe and well-tolerated.’
Saturday, September 18, 2010
Shark Liver Oil and Cartilage could provide Rescue
By Debbie Nicholson
Sharks are labeled with a bad persona. Mainly due to movies like "Jaws" where they go around and chomp down for a nightly feast on any human or animal they can find. There are one million slaughters going on each year on this creature. However, these creatures of the sea have the ability to aide in certain medical conditions such as anemia, brain bleeding and cancer.
Scientists for decades have been studying the shark, well at least his cartilage. They believe this creature has something that can offer the medical community especially in the treatment of cancer. It is a known fact that sharks hardly ever get cancer. There must be something in their bodies that aide in protection from this disease.
The theory of the shark cartilage and cancer among most of the scientific community is having to do specifically with the composition of the cartilage. For one thing cartilage cannot grow cancer due to the fact it has no blood vessels. The theory is that the cartilage manufactures elements that barricade the growing of new blood vessels that would feed on the tumor. So by using the cartilage to treat the tumor the blood vessels then should be stopped from developing on the tumor.
A study was performed to scientifically prove or disprove the theory of shark cartilage. Nine patients had participated in this study. When the study had been completed the evidence indicated that seven of the nine patients who had advanced cancer there was an 87% positive response from the treatment. It is important to note that no other treatment was applied during this study.
The evidence laid out had shown the following results (in brief form here after seven weeks of treatment and all patients were diagnosed as terminal)
A few results:
Female patient stage three uterine cancer going into bladder. Radiation had no effects on the tumor. After seven weeks of the cartilage the tumor reduced in size by 80% and after eleven weeks the tumor had gone and so did her pain. The only remaining factor was scar tissue.
Female with vaginal hemangioma in size of 5"x 5" after hysterectomy and partial vaginectomy along with radiation. Heavy bleeding was life threatening complication. At seven weeks tumor reduced by 60% and bleeding had stopped. At eleven weeks tumor size was 3"x 3" with further treatment it was stated tumor would appear to decrease.
Male stage three cancer on back of right thigh. After nine weeks of cartilage therapy surgery was done. It was noticed that 60% of the tumor was dead and surgically removed.
The summary of this research had indicated that further research was still required but shark cartilage treatments had displayed promise.
Studies on shark cartilage are still being conducted however, these studies are extremely expensive. At the same time environmentalists are advocating for the shark and making the fact known that the shark population has decreased significantly in the prior fifteen years due to over fishing and the ever on going demand for shark products.
The compounds of the shark cartilage are being tested by a few pharmaceutical companies. If developed it would only be able to be available by prescription and it is stated the cartilage is coming from those sharks who have been slaughtered for meat.
Shark cartilage in research has shown it can help alleviate arthritis symptoms. In all reality scientists had determined it is one of the main components in the shark cartilage which is chondroitin sulfate that is the magic behind the alleviation. To make a note the supplements which are sold in health food stores usually come from cows and that of sharks.
Shark cartilage has demonstrated benefits in patients with arthritis. It decrease joint pain and inflammation which enabled patients to use less pain relievers. Good news is a lot of persons who use it in small doses have no major problems. Some can have side effects which include nausea, vomiting, cramping, can lower blood pressure and raise sugar levels. Pregnant women, children and those recovering from surgery are advised against using the product. It has been validated for use in osteoporosis.
Shark cartilage has also been noted to be used for psoriasis, healing wounds, retina damage due to diabetes and inflammation of the intestines. The FDA has given the cartilage "Orphan Drug Status"for renal cell carcinoma. This law allows drug pharmaceuticals special incentives to study drugs for rare conditions.
Currently there has been no reported cases for drug interactions of this product. Doses are dependent on a variety of factors such as age, health and other conditions. There is no current information for proper dosage of this product. Follow directions on label and consult health practitioner before using this product.
Shark liver oil is also being used to treat health conditions. The liver oil is either brown or yellow in appearance. Fisherman for a very long time have used the oil for health treatments. The oil is an abundant source alkyiglycerols which just possibly contain anti-cancer elements. There are currently two other chemicals in the oil which are being studied for cancer they are squalene and squalamine.
Shark liver oil is vastly used in northern Europe as one of the conventional cancer treatments. However, in the United States it is sold as a dietary supplement. Current research is aiming at the components of the oil alkyiglycerols, squalene and squalamone. Past scientific studies have demonstrated the oil possibly has anti-cancer reactions on tumors in animals. Clinical trails based on if it works in humans are currently being studied.
We do know that shark liver oil aides in heightening the immune system, fighting infections, in cancer treatments (northern Europe) and decreases side effects of conventional cancer treatments.
The theory of the alkyiglycerols provide benefits in several different ways. It has been proposed that when fighting cancer they kill off the tumor cells indirectly. Advocates allege they stimulate the immune system by activation of immune cells (macrophages) that eat germs that are trying to penetrate along with damaged cells. The other way is that they have the ability to lessen side effects from chemotherapy and radiation therapy. This is due to the fact they can guard the cell membrane.
Due to the ability to heighten the immune system, there are claims that they provide protection against colds, flu, chronic infections, asthma, arthritis and AIDS.
Previous studies have demonstrated that squalamine can slow down the growing of tumor blood vessels. Advocates lay claim that it just possibly could treat cancer either independently or with chemotherapy. It is currently in studies for macular degeneration, eye condition in which ends in vision loss. Squalene is advocated to having cell protection ability which in turn could possibly lessen side effects that occur from chemotherapy.
All claims to shark liver oil are currently being researched.
Based on how the oil is prepared for commercial use it possibly can be loaded with omega 3 fatty acids and Vitamin A. The oil has been used in already in some moisturizing skin creams and lotions. Just to note some cosmetic companies have removed the ingredient over concern for the decline in the shark population.
The shark liver oil is being sold in capsules and liquid forms. You can purchase it at many of the health food stores and over the internet.
To clarify a few points in the shark liver oil. There is no current evidence that the supplement are effective to treat cancer. There have been a couple of studies that did present some benefit to women who were having radiation therapy for cervical cancer. There has been no other confirmed research in this area since 1980.
Recent studies have demonstrated squalamine has lessened the amounts of lung metastases, tumors in which spread to lungs from a primary cancer which is elsewhere in the body and this was found in animals. Studies conducted early in humans did show it can be used safely with chemotherapy. It is still not determined if it does shrink the tumor or prolongs survival of patients. It is undergoing studies with other treatments for lung and prostate cancers.
Some side effects include nausea and upset stomachs have been noted. In animal studies it had shown it could raise blood pressure. If you are allergic to seafood you could have a reaction.
The dosage for shark liver oil is also undetermined at this time so it is advisable to talk with your practitioner first.
Please do not use this product on its own current merit solely. It is used to aide in other treatments and best used with the advice of your health care practitioner.
Sharks are labeled with a bad persona. Mainly due to movies like "Jaws" where they go around and chomp down for a nightly feast on any human or animal they can find. There are one million slaughters going on each year on this creature. However, these creatures of the sea have the ability to aide in certain medical conditions such as anemia, brain bleeding and cancer.
Scientists for decades have been studying the shark, well at least his cartilage. They believe this creature has something that can offer the medical community especially in the treatment of cancer. It is a known fact that sharks hardly ever get cancer. There must be something in their bodies that aide in protection from this disease.
The theory of the shark cartilage and cancer among most of the scientific community is having to do specifically with the composition of the cartilage. For one thing cartilage cannot grow cancer due to the fact it has no blood vessels. The theory is that the cartilage manufactures elements that barricade the growing of new blood vessels that would feed on the tumor. So by using the cartilage to treat the tumor the blood vessels then should be stopped from developing on the tumor.
A study was performed to scientifically prove or disprove the theory of shark cartilage. Nine patients had participated in this study. When the study had been completed the evidence indicated that seven of the nine patients who had advanced cancer there was an 87% positive response from the treatment. It is important to note that no other treatment was applied during this study.
The evidence laid out had shown the following results (in brief form here after seven weeks of treatment and all patients were diagnosed as terminal)
A few results:
Female patient stage three uterine cancer going into bladder. Radiation had no effects on the tumor. After seven weeks of the cartilage the tumor reduced in size by 80% and after eleven weeks the tumor had gone and so did her pain. The only remaining factor was scar tissue.
Female with vaginal hemangioma in size of 5"x 5" after hysterectomy and partial vaginectomy along with radiation. Heavy bleeding was life threatening complication. At seven weeks tumor reduced by 60% and bleeding had stopped. At eleven weeks tumor size was 3"x 3" with further treatment it was stated tumor would appear to decrease.
Male stage three cancer on back of right thigh. After nine weeks of cartilage therapy surgery was done. It was noticed that 60% of the tumor was dead and surgically removed.
The summary of this research had indicated that further research was still required but shark cartilage treatments had displayed promise.
Studies on shark cartilage are still being conducted however, these studies are extremely expensive. At the same time environmentalists are advocating for the shark and making the fact known that the shark population has decreased significantly in the prior fifteen years due to over fishing and the ever on going demand for shark products.
The compounds of the shark cartilage are being tested by a few pharmaceutical companies. If developed it would only be able to be available by prescription and it is stated the cartilage is coming from those sharks who have been slaughtered for meat.
Shark cartilage in research has shown it can help alleviate arthritis symptoms. In all reality scientists had determined it is one of the main components in the shark cartilage which is chondroitin sulfate that is the magic behind the alleviation. To make a note the supplements which are sold in health food stores usually come from cows and that of sharks.
Shark cartilage has demonstrated benefits in patients with arthritis. It decrease joint pain and inflammation which enabled patients to use less pain relievers. Good news is a lot of persons who use it in small doses have no major problems. Some can have side effects which include nausea, vomiting, cramping, can lower blood pressure and raise sugar levels. Pregnant women, children and those recovering from surgery are advised against using the product. It has been validated for use in osteoporosis.
Shark cartilage has also been noted to be used for psoriasis, healing wounds, retina damage due to diabetes and inflammation of the intestines. The FDA has given the cartilage "Orphan Drug Status"for renal cell carcinoma. This law allows drug pharmaceuticals special incentives to study drugs for rare conditions.
Currently there has been no reported cases for drug interactions of this product. Doses are dependent on a variety of factors such as age, health and other conditions. There is no current information for proper dosage of this product. Follow directions on label and consult health practitioner before using this product.
Shark liver oil is also being used to treat health conditions. The liver oil is either brown or yellow in appearance. Fisherman for a very long time have used the oil for health treatments. The oil is an abundant source alkyiglycerols which just possibly contain anti-cancer elements. There are currently two other chemicals in the oil which are being studied for cancer they are squalene and squalamine.
Shark liver oil is vastly used in northern Europe as one of the conventional cancer treatments. However, in the United States it is sold as a dietary supplement. Current research is aiming at the components of the oil alkyiglycerols, squalene and squalamone. Past scientific studies have demonstrated the oil possibly has anti-cancer reactions on tumors in animals. Clinical trails based on if it works in humans are currently being studied.
We do know that shark liver oil aides in heightening the immune system, fighting infections, in cancer treatments (northern Europe) and decreases side effects of conventional cancer treatments.
The theory of the alkyiglycerols provide benefits in several different ways. It has been proposed that when fighting cancer they kill off the tumor cells indirectly. Advocates allege they stimulate the immune system by activation of immune cells (macrophages) that eat germs that are trying to penetrate along with damaged cells. The other way is that they have the ability to lessen side effects from chemotherapy and radiation therapy. This is due to the fact they can guard the cell membrane.
Due to the ability to heighten the immune system, there are claims that they provide protection against colds, flu, chronic infections, asthma, arthritis and AIDS.
Previous studies have demonstrated that squalamine can slow down the growing of tumor blood vessels. Advocates lay claim that it just possibly could treat cancer either independently or with chemotherapy. It is currently in studies for macular degeneration, eye condition in which ends in vision loss. Squalene is advocated to having cell protection ability which in turn could possibly lessen side effects that occur from chemotherapy.
All claims to shark liver oil are currently being researched.
Based on how the oil is prepared for commercial use it possibly can be loaded with omega 3 fatty acids and Vitamin A. The oil has been used in already in some moisturizing skin creams and lotions. Just to note some cosmetic companies have removed the ingredient over concern for the decline in the shark population.
The shark liver oil is being sold in capsules and liquid forms. You can purchase it at many of the health food stores and over the internet.
To clarify a few points in the shark liver oil. There is no current evidence that the supplement are effective to treat cancer. There have been a couple of studies that did present some benefit to women who were having radiation therapy for cervical cancer. There has been no other confirmed research in this area since 1980.
Recent studies have demonstrated squalamine has lessened the amounts of lung metastases, tumors in which spread to lungs from a primary cancer which is elsewhere in the body and this was found in animals. Studies conducted early in humans did show it can be used safely with chemotherapy. It is still not determined if it does shrink the tumor or prolongs survival of patients. It is undergoing studies with other treatments for lung and prostate cancers.
Some side effects include nausea and upset stomachs have been noted. In animal studies it had shown it could raise blood pressure. If you are allergic to seafood you could have a reaction.
The dosage for shark liver oil is also undetermined at this time so it is advisable to talk with your practitioner first.
Please do not use this product on its own current merit solely. It is used to aide in other treatments and best used with the advice of your health care practitioner.
Monday, September 13, 2010
AstraZeneca joins UCL to find stem cell cure for diabetic blindness
* Julia Kollewe
12 September 2010
AstraZeneca and University College London (UCL) will announce a research partnership tomorrow to develop medicines that use stem cells to repair damaged eyesight in people with diabetes.
Under the three-year deal funded by the drugmaker, researchers from AstraZeneca will team up with scientists at the UCL Institute of Ophthalmology to work on new medicines that use the regenerative capacity of stem cells. They hope to come up with a compound in three to five years, which could then undergo clinical development and possibly be on the market in 10 years' time.
Dr Marcus Fruttiger of the UCL Institute of Ophthalmology, who is leading the project, said: "These tools could be used either to manufacture transplantable material or to directly stimulate new cell growth in the eye to help restore or improve the vision of those with diabetic retinopathy [DR]."
DR is now the most common cause of vision impairment or blindness among western people of working age. The majority of patients with type-1 diabetes, which occurs when the body produces no insulin and often develops during the teenage years, will suffer eyesight problems and about 20%-30% will become blind. Moreover, at least 50% of patients with type-2 diabetes – the far more common type of diabetes, which occurs when the body produces too little insulin or when cells in the body do not react properly to insulin – will also develop retinopathy over time.
With the rapid spread of type-2 diabetes, which is linked to obesity, the need for a retinopathy treatment will grow as more than 438 million people are expected to suffer from diabetes by 2030. A study published this year by Oxford University predicted that eight out of 10 men and almost seven in 10 women will be overweight or obese by 2020. It forecast a 98% rise in obesity-related diabetes by 2050.
Alan Lamont, director of sciences and technology alliances at AstraZeneca. said: "We're getting very keen on the whole area of regenerative medicines and they will be part of our research development over the next few years." He said the collaboration aimed to come up with a treatment that could be administered to the back of the eye to repair damage locally.
AstraZeneca's US rival Pfizer also has a partnership with Professor Pete Coffey of the UCL Institute of Ophthalmology, for another eye condition, macular degeneration. Coffey said: "It's great that 'Big Pharma' is considering regenerative medicines as a serious possibility." He added: "This is British science being developed into a commercial entity with the pharmaceutical industry. It's a good example why the government shouldn't cut funding for biomedical research."
While this is the first time that AstraZeneca has worked on medicine for retinopathy, diabetes has been an area of focus. The company has a new diabetes treatment on the market called Onglyza, which was developed with Bristol-Myers Squibb, and the companies are developing a second diabetes drug that could be submitted to regulators for approval later this year.
12 September 2010
AstraZeneca and University College London (UCL) will announce a research partnership tomorrow to develop medicines that use stem cells to repair damaged eyesight in people with diabetes.
Under the three-year deal funded by the drugmaker, researchers from AstraZeneca will team up with scientists at the UCL Institute of Ophthalmology to work on new medicines that use the regenerative capacity of stem cells. They hope to come up with a compound in three to five years, which could then undergo clinical development and possibly be on the market in 10 years' time.
Dr Marcus Fruttiger of the UCL Institute of Ophthalmology, who is leading the project, said: "These tools could be used either to manufacture transplantable material or to directly stimulate new cell growth in the eye to help restore or improve the vision of those with diabetic retinopathy [DR]."
DR is now the most common cause of vision impairment or blindness among western people of working age. The majority of patients with type-1 diabetes, which occurs when the body produces no insulin and often develops during the teenage years, will suffer eyesight problems and about 20%-30% will become blind. Moreover, at least 50% of patients with type-2 diabetes – the far more common type of diabetes, which occurs when the body produces too little insulin or when cells in the body do not react properly to insulin – will also develop retinopathy over time.
With the rapid spread of type-2 diabetes, which is linked to obesity, the need for a retinopathy treatment will grow as more than 438 million people are expected to suffer from diabetes by 2030. A study published this year by Oxford University predicted that eight out of 10 men and almost seven in 10 women will be overweight or obese by 2020. It forecast a 98% rise in obesity-related diabetes by 2050.
Alan Lamont, director of sciences and technology alliances at AstraZeneca. said: "We're getting very keen on the whole area of regenerative medicines and they will be part of our research development over the next few years." He said the collaboration aimed to come up with a treatment that could be administered to the back of the eye to repair damage locally.
AstraZeneca's US rival Pfizer also has a partnership with Professor Pete Coffey of the UCL Institute of Ophthalmology, for another eye condition, macular degeneration. Coffey said: "It's great that 'Big Pharma' is considering regenerative medicines as a serious possibility." He added: "This is British science being developed into a commercial entity with the pharmaceutical industry. It's a good example why the government shouldn't cut funding for biomedical research."
While this is the first time that AstraZeneca has worked on medicine for retinopathy, diabetes has been an area of focus. The company has a new diabetes treatment on the market called Onglyza, which was developed with Bristol-Myers Squibb, and the companies are developing a second diabetes drug that could be submitted to regulators for approval later this year.
Saturday, September 4, 2010
Federal stem cell ruling blocks Yale scientists
By Rachel Gilmore
For two decades, Lawrence Rizzolo, the director of medical studies at the Yale School of Medicine, has been working toward a project that aims to transplant young, healthy retinal cells to replace diseased tissues in the eyes of patients who are going blind.
But now Rizzolo fears he may have to delay, or even stop, his research because of last week’s ruling by a federal judge that prevents federal funding for studies involving embryonic stem cells, the building blocks for human organs and tissues that Rizzolo needs for his project.
Rizzolo had applied for a grant from the National Institutes of Health to replace his funding from the nonprofit International Retinal Research Foundation, which ends in December. Rizzolo also has a three-year state grant from Rocky Hill, Conn.-based state holding company Connecticut Innovations, but he says he cannot continue his research without the federal funding.
Rizzolo’s laboratory is one of about a dozen facilities on campus that use stem cells. Haifan Lin, director of the Yale Stem Cell Center, said he did not yet know how the moratorium will affect Yale researchers.
“We’re all waiting for clarification on the implications of the judge’s ruling,” University President Richard Levin said.
But frozen funding could lead scientists to lose their jobs. Rizzolo said that although a fourth researcher will join his laboratory in October, he may soon have to fire his workers because the grants and not the University pay for his researchers’ salaries.
Although the U.S. Department of Justice has filed a motion seeking to delay the federal judge’s ban on funding, the relief would only be temporary, NIH spokesman Don Ralbovsky said. The Justice Department declined to comment Thursday.
Opponents of embryonic stem cell research have hailed the ruling.
“The American people should not be forced to pay for experiments — prohibited by federal law — that destroy human life,” said Steven Aden, the legal counsel for the Alliance Defense Fund, which advised the party that brought the lawsuit to court.
Most labs at Yale’s Stem Cell Center are supported primarily by state funds, which are not affected by the ruling, said Diane Krause, the center’s assistant director. But, she explained, those state grants were meant to be a springboard for acquiring federal funding.
“Discontinuation of NIH funding of work with human embryonic stem cells could be a disaster,” she said.
School of Medicine Dean Robert Alpern agreed, saying that halting the stem cell research would be a “loss to society.”
Krause and other Yale researchers met Aug. 26 with Connecticut attorney general and U.S. Senate candidate Richard Blumenthal LAW ’73, who told the News this week that he plans to file a brief in support of the appeal.
“It is incredibly important for our scientific and legislative leaders to come together and solve this issue quickly,” Blumenthal said in a statement. “We have already lost so many years of work to backwards-looking and bureaucratic federal policy.”
Linda McMahon, his Republican challenger for Chris Dodd’s Senate seat, also supports stem cell research, according to her website. The McMahon campaign did not respond to multiple phone requests for comment this week.
Even if the Justice Department successfully delays the ruling, NIH has not said whether it would accept new applications. That would be a problem for Yibing Qyang, an assistant professor of cardiology at the School of Medicine who currently has a $95,499 federal grant and had planned on applying for another in October.
“I cannot live without federal funding,” said Qyang, who is priming stem cells to become healthy heart cells in patients with heart disease.
Yale has received at least $17 million in state funding from a $100 million stem cell research pot funded in part by tobacco taxes. It also received $4.9 million in NIH stem cell research grants in 2009 and 2010. NIH gave $123 million to researchers in fiscal year 2010 for embryonic stem cell research, Ralbovsky said.
Rizzolo studies eye tissues called retinal pigment epithelia. Many eye diseases — including macular degeneration, from which more than 10 million Americans suffer — affect these tissues, which function as a support for the retina, the part of the eye responsible for sight. Doctors have tried to transplant retinal and epithelial cells to combat these diseases. But most of the transplants fail because they are risky and the patients who choose to undergo them are usually almost blind. Patients in the early stages of macular degeneration are unlikely to attempt a transplant; Rizzolo said he hopes that his research with stem cells, which he started to use about a year ago, would lead to other, less risky, treatments for the disease.
Rizzolo added that, in the past year, two Yale colleagues had entirely shut down their stem-cell research labs because of funding shortages.
“It’s pretty frustrating when you work so hard to see something go unfunded for political reasons,” he said.
The Yale Stem Cell Center, established in 2006, brings together more than 30 faculty members across the University.
For two decades, Lawrence Rizzolo, the director of medical studies at the Yale School of Medicine, has been working toward a project that aims to transplant young, healthy retinal cells to replace diseased tissues in the eyes of patients who are going blind.
But now Rizzolo fears he may have to delay, or even stop, his research because of last week’s ruling by a federal judge that prevents federal funding for studies involving embryonic stem cells, the building blocks for human organs and tissues that Rizzolo needs for his project.
Rizzolo had applied for a grant from the National Institutes of Health to replace his funding from the nonprofit International Retinal Research Foundation, which ends in December. Rizzolo also has a three-year state grant from Rocky Hill, Conn.-based state holding company Connecticut Innovations, but he says he cannot continue his research without the federal funding.
Rizzolo’s laboratory is one of about a dozen facilities on campus that use stem cells. Haifan Lin, director of the Yale Stem Cell Center, said he did not yet know how the moratorium will affect Yale researchers.
“We’re all waiting for clarification on the implications of the judge’s ruling,” University President Richard Levin said.
But frozen funding could lead scientists to lose their jobs. Rizzolo said that although a fourth researcher will join his laboratory in October, he may soon have to fire his workers because the grants and not the University pay for his researchers’ salaries.
Although the U.S. Department of Justice has filed a motion seeking to delay the federal judge’s ban on funding, the relief would only be temporary, NIH spokesman Don Ralbovsky said. The Justice Department declined to comment Thursday.
Opponents of embryonic stem cell research have hailed the ruling.
“The American people should not be forced to pay for experiments — prohibited by federal law — that destroy human life,” said Steven Aden, the legal counsel for the Alliance Defense Fund, which advised the party that brought the lawsuit to court.
Most labs at Yale’s Stem Cell Center are supported primarily by state funds, which are not affected by the ruling, said Diane Krause, the center’s assistant director. But, she explained, those state grants were meant to be a springboard for acquiring federal funding.
“Discontinuation of NIH funding of work with human embryonic stem cells could be a disaster,” she said.
School of Medicine Dean Robert Alpern agreed, saying that halting the stem cell research would be a “loss to society.”
Krause and other Yale researchers met Aug. 26 with Connecticut attorney general and U.S. Senate candidate Richard Blumenthal LAW ’73, who told the News this week that he plans to file a brief in support of the appeal.
“It is incredibly important for our scientific and legislative leaders to come together and solve this issue quickly,” Blumenthal said in a statement. “We have already lost so many years of work to backwards-looking and bureaucratic federal policy.”
Linda McMahon, his Republican challenger for Chris Dodd’s Senate seat, also supports stem cell research, according to her website. The McMahon campaign did not respond to multiple phone requests for comment this week.
Even if the Justice Department successfully delays the ruling, NIH has not said whether it would accept new applications. That would be a problem for Yibing Qyang, an assistant professor of cardiology at the School of Medicine who currently has a $95,499 federal grant and had planned on applying for another in October.
“I cannot live without federal funding,” said Qyang, who is priming stem cells to become healthy heart cells in patients with heart disease.
Yale has received at least $17 million in state funding from a $100 million stem cell research pot funded in part by tobacco taxes. It also received $4.9 million in NIH stem cell research grants in 2009 and 2010. NIH gave $123 million to researchers in fiscal year 2010 for embryonic stem cell research, Ralbovsky said.
Rizzolo studies eye tissues called retinal pigment epithelia. Many eye diseases — including macular degeneration, from which more than 10 million Americans suffer — affect these tissues, which function as a support for the retina, the part of the eye responsible for sight. Doctors have tried to transplant retinal and epithelial cells to combat these diseases. But most of the transplants fail because they are risky and the patients who choose to undergo them are usually almost blind. Patients in the early stages of macular degeneration are unlikely to attempt a transplant; Rizzolo said he hopes that his research with stem cells, which he started to use about a year ago, would lead to other, less risky, treatments for the disease.
Rizzolo added that, in the past year, two Yale colleagues had entirely shut down their stem-cell research labs because of funding shortages.
“It’s pretty frustrating when you work so hard to see something go unfunded for political reasons,” he said.
The Yale Stem Cell Center, established in 2006, brings together more than 30 faculty members across the University.
Sunday, August 29, 2010
Gene involved in Fuchs Corneal dystrophy is found
A 13-member research team led by University of Oregon scientist Dr. Albert O. Edwards has found a gene likely responsible for Fuchs corneal dystrophy, an inheritable genetic disorder and leading cause of corneal transplant operations.
Edwards performed a genome-wide analysis comparing patients with and without typical age-related Fuchs, finding an alteration in the transcription-factor-4 gene (TCF4). Fuchs -- pronounced FEWKS or FOOKS -- generally emerges in middle-aged, roughly age 40, and older people.
The discovery appears online Wednesday, Aug. 25, ahead of regular publication in the Sept. 9 issue of the New England Journal of Medicine.
Fuchs emerges slowly with blurred or cloudy vision, tiny bumps known as guttae (GOO-tay) on the cornea's surface and, in severe stages, painful blisters on the corneal surface. The disease affects the endothelium, a thin layer of cells that line the back part of the cornea where changes result in swelling of the cornea and thickening and clouding of the cornea. Guttae are found in the corneas of an estimated 5 percent of people in the United States.
Of those diagnosed with Fuchs, only a small percentage go on to require corneal transplants, said lead author Dr. Keith H. Baratz of the Mayo Clinic ophthalmology department in Rochester, Minn. There are about 40,000 corneal transplants -- about 10,000 linked to Fuchs -- performed annually in the United States, according to the Eye Bank Association of America. It is more common in women than in men, according to the Fuchs Corneal Dystrophy Association.
The discovery won't immediately translate into clinical benefits, but "this is the first step in identifying the pathophysiology of the disease," Baratz said. "Right now, we don't have a treatment for Fuchs dystrophy other than transplant surgery when a patient is at the end stages of the disease. The ultimate goal is to find out how the disease occurs and find a treatment to prevent or slow its progression."
Having the TCF4 gene variation has a huge impact on the risk of Fuchs disease, said Edwards, a senior research associate in the University of Oregon's Institute of Molecular Biology. "It vastly exceeds the risk found previously for the complement-factor-H gene in macular degeneration," he said. "If a person has risk variants involving TCF4, that individual is anywhere from several to a couple of hundred times more likely to have Fuchs disease."
Edwards, in 2005, when at the University of Texas Southwestern Medical Center, was lead author of a study published in the journal Science that identified complement factor H in macular degeneration. That gene discovery tied complement factor H to a five-fold increase of risk to developing macular degeneration, accounting possibly for at least 50 percent of the risk of being affected. The risk impact of TCF4 on Fuchs is much stronger, Edwards said.
While the TCF4 gene has been identified, exactly what occurs to cause a defect is not understood. The researchers found evidence that at least one transcription protein, E2-2, needs more scrutiny. "E2-2 is a transcription factor. It controls gene expression," Edwards said. "The pathway probably contains E2-2 and the protein ZEB1, but we don't really know that yet. We do find variation of expression across this region, so it has something to do with the expression of the gene."
E2-2, important in cellular growth and differentiation, has been implicated in other disease states, including activity that promotes or suppresses cancer. It is expressed in the corneal endothelium. ZEB1, which may be regulated by E2-2, already is thought to contribute to Fuchs.
The study involved the genotyping of 280 Fuchs patients recruited in clinical settings in Minnesota and Michigan. These patients had at least Stage 1 signs of Fuchs or had received corneal replacements as a result of the disease. Their genomes were compared with 410 control patients.
"The real impact of what we've done is to determine the biological underpinnings of the disease," Edwards said. "We've identified a protein that is probably involved, and that will allow us to, hopefully, identify a method to prevent people from losing their vision."
Three other genes previously had been linked to very rare subtypes of Fuchs. In addition, early onset Fuchs has been linked to mutations in yet another gene, COL8A2, but Edwards and colleagues suggest in their paper that this may be a different disease with a different cause.
"This discovery demonstrates the value of excellent clinical phenotyping and a large-scale genetic database of genome-wide association studies (GWAS) to uncover genetic risk factors for many vision-related disorders," said co-author Anand Swaroop, chief of the National Eye Institute (NEI) Neurobiology-Neurodegeneration and Repair Laboratory. "The genetic data used in this study was obtained for GWAS of age-related macular degeneration through a scientific collaboration supported by the NEI."
Edwards performed a genome-wide analysis comparing patients with and without typical age-related Fuchs, finding an alteration in the transcription-factor-4 gene (TCF4). Fuchs -- pronounced FEWKS or FOOKS -- generally emerges in middle-aged, roughly age 40, and older people.
The discovery appears online Wednesday, Aug. 25, ahead of regular publication in the Sept. 9 issue of the New England Journal of Medicine.
Fuchs emerges slowly with blurred or cloudy vision, tiny bumps known as guttae (GOO-tay) on the cornea's surface and, in severe stages, painful blisters on the corneal surface. The disease affects the endothelium, a thin layer of cells that line the back part of the cornea where changes result in swelling of the cornea and thickening and clouding of the cornea. Guttae are found in the corneas of an estimated 5 percent of people in the United States.
Of those diagnosed with Fuchs, only a small percentage go on to require corneal transplants, said lead author Dr. Keith H. Baratz of the Mayo Clinic ophthalmology department in Rochester, Minn. There are about 40,000 corneal transplants -- about 10,000 linked to Fuchs -- performed annually in the United States, according to the Eye Bank Association of America. It is more common in women than in men, according to the Fuchs Corneal Dystrophy Association.
The discovery won't immediately translate into clinical benefits, but "this is the first step in identifying the pathophysiology of the disease," Baratz said. "Right now, we don't have a treatment for Fuchs dystrophy other than transplant surgery when a patient is at the end stages of the disease. The ultimate goal is to find out how the disease occurs and find a treatment to prevent or slow its progression."
Having the TCF4 gene variation has a huge impact on the risk of Fuchs disease, said Edwards, a senior research associate in the University of Oregon's Institute of Molecular Biology. "It vastly exceeds the risk found previously for the complement-factor-H gene in macular degeneration," he said. "If a person has risk variants involving TCF4, that individual is anywhere from several to a couple of hundred times more likely to have Fuchs disease."
Edwards, in 2005, when at the University of Texas Southwestern Medical Center, was lead author of a study published in the journal Science that identified complement factor H in macular degeneration. That gene discovery tied complement factor H to a five-fold increase of risk to developing macular degeneration, accounting possibly for at least 50 percent of the risk of being affected. The risk impact of TCF4 on Fuchs is much stronger, Edwards said.
While the TCF4 gene has been identified, exactly what occurs to cause a defect is not understood. The researchers found evidence that at least one transcription protein, E2-2, needs more scrutiny. "E2-2 is a transcription factor. It controls gene expression," Edwards said. "The pathway probably contains E2-2 and the protein ZEB1, but we don't really know that yet. We do find variation of expression across this region, so it has something to do with the expression of the gene."
E2-2, important in cellular growth and differentiation, has been implicated in other disease states, including activity that promotes or suppresses cancer. It is expressed in the corneal endothelium. ZEB1, which may be regulated by E2-2, already is thought to contribute to Fuchs.
The study involved the genotyping of 280 Fuchs patients recruited in clinical settings in Minnesota and Michigan. These patients had at least Stage 1 signs of Fuchs or had received corneal replacements as a result of the disease. Their genomes were compared with 410 control patients.
"The real impact of what we've done is to determine the biological underpinnings of the disease," Edwards said. "We've identified a protein that is probably involved, and that will allow us to, hopefully, identify a method to prevent people from losing their vision."
Three other genes previously had been linked to very rare subtypes of Fuchs. In addition, early onset Fuchs has been linked to mutations in yet another gene, COL8A2, but Edwards and colleagues suggest in their paper that this may be a different disease with a different cause.
"This discovery demonstrates the value of excellent clinical phenotyping and a large-scale genetic database of genome-wide association studies (GWAS) to uncover genetic risk factors for many vision-related disorders," said co-author Anand Swaroop, chief of the National Eye Institute (NEI) Neurobiology-Neurodegeneration and Repair Laboratory. "The genetic data used in this study was obtained for GWAS of age-related macular degeneration through a scientific collaboration supported by the NEI."
Tuesday, July 20, 2010
Alcon Terminates the Development of Anecortave Acetate in Age-Related Macular Degeneration
HUENENBERG, Switzerland -- Alcon, Inc. (NYSE:ACL) announced today it has terminated the development program designed to evaluate the benefit of anecortave acetate treatment on the risk for developing sight-threatening choroidal neovascularization secondary to age-related macular degeneration. The decision followed a planned interim analysis of studies C-02-60 A and B that was performed after 2,546 patients had completed the 24 month time point. In this analysis, anecortave acetate showed no effect on the primary or secondary endpoints. In addition to terminating studies C-02-60 A and B, the company also terminated two smaller studies with an identical design that were being conducted in Asia, C-04-30 and C-05-34.
The company continues to study anecortave acetate administered as an anterior juxtascleral depot to reduce intraocular pressure in patients with open-angle glaucoma.
About Alcon
Alcon, Inc. is the world's leading eye care company, with sales of approximately $5.6 billion in 2007. Alcon, which has been dedicated to the ophthalmic industry for more than 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon's majority shareholder is Nestle, S.A., the world's largest food company. For more information on Alcon Inc., visit the company's Web site at www.alcon.com.
The company continues to study anecortave acetate administered as an anterior juxtascleral depot to reduce intraocular pressure in patients with open-angle glaucoma.
About Alcon
Alcon, Inc. is the world's leading eye care company, with sales of approximately $5.6 billion in 2007. Alcon, which has been dedicated to the ophthalmic industry for more than 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon's majority shareholder is Nestle, S.A., the world's largest food company. For more information on Alcon Inc., visit the company's Web site at www.alcon.com.
Wednesday, July 7, 2010
Miniature Telescope for Eye Approved for Macular Degeneration
TUESDAY, July 6 (HealthDay News) -- A tiny telescope that's implanted in an eye affected by advanced age-related macular degeneration (AMD) has been approved by the U.S. Food and Drug Administration.
The Implantable Miniature Telescope replaces the natural lens and magnifies an image more than two times, the FDA said in a news release.
The device is meant for people aged 75 and older who have blind spots associated with end-stage AMD. Candidates will be trained with an external telescopic device to see if they may benefit from the implanted product, the agency said.
AMD damages the eye's macula, causing vision loss in the center of the visual field. The condition affects mostly older people, often making it impossible to recognize faces or perform tasks such as watching television, the FDA said. Some 8 million Americans have been diagnosed with the condition, and about 25 percent of those are significantly visually impaired.
The FDA said it's requiring the labeling to warn that the device puts users at greater risk of injury to the eye's cornea.
As a condition of approval, California-based VisionCare Ophthalmic Technologies will conduct two follow-up studies of the device, the agency said.
More information
To learn more about AMD, visit the U.S. National Eye Institute.
Copyright © 2010 ScoutNews, LLC. All rights reserved.
HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov.
The Implantable Miniature Telescope replaces the natural lens and magnifies an image more than two times, the FDA said in a news release.
The device is meant for people aged 75 and older who have blind spots associated with end-stage AMD. Candidates will be trained with an external telescopic device to see if they may benefit from the implanted product, the agency said.
AMD damages the eye's macula, causing vision loss in the center of the visual field. The condition affects mostly older people, often making it impossible to recognize faces or perform tasks such as watching television, the FDA said. Some 8 million Americans have been diagnosed with the condition, and about 25 percent of those are significantly visually impaired.
The FDA said it's requiring the labeling to warn that the device puts users at greater risk of injury to the eye's cornea.
As a condition of approval, California-based VisionCare Ophthalmic Technologies will conduct two follow-up studies of the device, the agency said.
More information
To learn more about AMD, visit the U.S. National Eye Institute.
Copyright © 2010 ScoutNews, LLC. All rights reserved.
HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov.
Wednesday, June 30, 2010
Alimera seek NDA for diabetic macular degeneration drug/device combo
June 29, 2010 by MassDevice staffpSivida Corp. and Alimera Sciences file a new drug application with the Food & Drug Administration for Iluvien, a drug/device combination aimed at treating diabetic macular degeneration.
pSivida Corp. (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) are seeking a green light from the Food & Drug Administration for a drug/device combination to treat diabetic macular degeneration.
Watertown, Mass.-based pSivida said Alimera, which licenses the Iluvien technology from pSivida, submitted a new drug application to the FDA. The technology is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball.
Alimera asked the federal watchdog for priority review, an expedited process that could bring an FDA response during the fourth quarter, according to a press release.
There are no approved drugs to treat DME, according to pSivida president and CEO Paul Ashton, adding that Iluvien is the company's third product aimed at back-of-the-eye diseases. The first two won FDA approval and are on the market, Ashton said: Retisert, for the treatment of posterior uveitis, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc.
The company is also working on a treatment for retinitis pigmentosa, which involves the gradual deterioration of the rods and cones that make up the retina. In April Ashton told MassDevice that its Durasert device also uses flucocinolone acetonide, a steroid, to treat the disease.
"What we've done is use a very small insertable drug delivery device to release a steroid directly into the eye that will just provide some protection and slow down the rates of vision loss," he said. "With a condition that takes 20 years to make you blind, if you slow it down by a factor of two, that's pretty good."
The partnership with Alimera has already paid dividends, namely a $15.3 million payment triggered by Alimera's April 21 initial public offering. At the time Ashton told us pSivida planned to use the cash to further develop its product pipeline. If the FDA gives the nod to Iluvien, it would trigger another, $25 million milestone payment from Alimera, plus 20 percent royalties on net profits from sales of the treatment.
For more information go to www.maculardegenerationassociation.org
pSivida Corp. (NSDQ:PSDV) and Alimera Sciences (NSDQ:ALIM) are seeking a green light from the Food & Drug Administration for a drug/device combination to treat diabetic macular degeneration.
Watertown, Mass.-based pSivida said Alimera, which licenses the Iluvien technology from pSivida, submitted a new drug application to the FDA. The technology is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball.
Alimera asked the federal watchdog for priority review, an expedited process that could bring an FDA response during the fourth quarter, according to a press release.
There are no approved drugs to treat DME, according to pSivida president and CEO Paul Ashton, adding that Iluvien is the company's third product aimed at back-of-the-eye diseases. The first two won FDA approval and are on the market, Ashton said: Retisert, for the treatment of posterior uveitis, and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. Both are licensed to Bausch & Lomb Inc.
The company is also working on a treatment for retinitis pigmentosa, which involves the gradual deterioration of the rods and cones that make up the retina. In April Ashton told MassDevice that its Durasert device also uses flucocinolone acetonide, a steroid, to treat the disease.
"What we've done is use a very small insertable drug delivery device to release a steroid directly into the eye that will just provide some protection and slow down the rates of vision loss," he said. "With a condition that takes 20 years to make you blind, if you slow it down by a factor of two, that's pretty good."
The partnership with Alimera has already paid dividends, namely a $15.3 million payment triggered by Alimera's April 21 initial public offering. At the time Ashton told us pSivida planned to use the cash to further develop its product pipeline. If the FDA gives the nod to Iluvien, it would trigger another, $25 million milestone payment from Alimera, plus 20 percent royalties on net profits from sales of the treatment.
For more information go to www.maculardegenerationassociation.org
Sunday, May 10, 2009
Researchers aim for rare treatment of macular degeneration
Friday, May 1, 2009
Researchers aim for rare treatment of macular degeneration
By Marc Songini
One of the most prevalent eye diseases is age-related macular degeneration, affecting millions in the United States, and there are few if any cures, or even approved treatments, say experts. That makes the work of a group of local researchers developing an implanted treatment particularly vital.
The AMD ailment takes two forms: One is “wet” and involves blood vessels and has limited treatments, including Lucentis, a drug from San Francisco-based Genentech Inc. (now part of Swiss firm Roche). The other is “dry” and occurs when light-sensitive cells malfunction. An estimated 15 million Americans have AMD.
For the 10 percent to 20 percent of AMD patients that have the wet form, the treatments are “reasonably effective,” said Paul Ashton, president and CEO of Watertown-based pSivida Corp., which develops eye treatments. “We have nothing for the 80 percent to 90 percent who have the dry form.” In part, this is because big pharma didn’t realize the huge market for eye treatments until about a decade ago, he said. Additionally, “Getting drugs into the eye without getting very high levels of drug everywhere else is very hard,” noted Ashton.
For dry AMD, in particular, there’s “a huge unmet need and a huge market,” said Emmett Cunningham, a partner with Cambridge-based Clarus Ventures LLC, a life sciences investment company. In part, said Cunningham, a doctor and eye expert based in Clarus’ South San Francisco office, this is because dry AMD is “complex,” and there is no one easily discerned cause. Also, there are no reliable animal models for testing.
“You’d have to take a big bet to get human proof of concept data,” he said. A venture capital firm would be prone to waiting till a dry AMD startup was in the Phase 2 or Phase 3 stage before investing the $20 million to move toward full approval.
However, one research team based at Boston College and the University of Massachusetts Medical School in Worcester is trying to solve the problems of AMD and other eye diseases by creating nano-structured retinal implants. These are tiny devices placed in the eye to take the place of the malfunctioning rods and cones in the retina, explained Michael Naughton, a professor of physics at BC, whose team is working on the nanotechnology of the implant.
“The implant is designed to reconnect to the surviving cell circuitry and provide the electronic stimulus formerly provided by the rods and cones,” said Naughton. Ideally, these implants could have a form factor similar to contact lenses. They would be widely available, although requiring retinal surgery. “Until such a time as genetic engineering can cure or regenerate rods and cones, these artificial retinas could provide a viable path to restoring vision.” Potentially, the market is worth hundreds of millions of dollars annually, he estimated.
Currently, he estimates that he needs $42 million to pay for the prototype and the animal and human studies over the next 18 months. He said there are no implants on the market for consumer use at this time, though a number are in development.
Cunningham noted that for an investor, implants are an interesting area, but the key is getting compelling data that the technical risks associated with the device have been met, because it requires surgical implantation. Also, a startup must demonstrate the size of the market is big enough related to the cost of the device, he said.
Other firms working to treat AMD and other eye ailments include Lincoln, R.I.-based Neurotech Pharmaceuticals Inc., whose lead candidate NT-501 is an intraocular implant made of genetically modified human cells. In March, it released Phase 2 exploratory study data that indicated positive results in AMD treatment, with no “serious adverse events,” said Ted Danse, president and CEO of Neurotech.
Also, pSivida’s drug Iluvien is in Phase 2 trials for both forms of AMD, said Ashton. And New Haven, Conn.-based Optherion Inc. is developing a diagnostic service and drug platform for AMD. By year’s end, Optherion plans to file an independent new drug application (IND) submission to the U.S. Food and Drug Administration for its drug, said Colin Foster, CEO and president.
For the past several years, Bedford-based Resolvyx Pharmaceuticals Inc. has been evaluating its Resolvin inflammation control drug’s effectiveness against AMD, as well.
Researchers aim for rare treatment of macular degeneration
By Marc Songini
One of the most prevalent eye diseases is age-related macular degeneration, affecting millions in the United States, and there are few if any cures, or even approved treatments, say experts. That makes the work of a group of local researchers developing an implanted treatment particularly vital.
The AMD ailment takes two forms: One is “wet” and involves blood vessels and has limited treatments, including Lucentis, a drug from San Francisco-based Genentech Inc. (now part of Swiss firm Roche). The other is “dry” and occurs when light-sensitive cells malfunction. An estimated 15 million Americans have AMD.
For the 10 percent to 20 percent of AMD patients that have the wet form, the treatments are “reasonably effective,” said Paul Ashton, president and CEO of Watertown-based pSivida Corp., which develops eye treatments. “We have nothing for the 80 percent to 90 percent who have the dry form.” In part, this is because big pharma didn’t realize the huge market for eye treatments until about a decade ago, he said. Additionally, “Getting drugs into the eye without getting very high levels of drug everywhere else is very hard,” noted Ashton.
For dry AMD, in particular, there’s “a huge unmet need and a huge market,” said Emmett Cunningham, a partner with Cambridge-based Clarus Ventures LLC, a life sciences investment company. In part, said Cunningham, a doctor and eye expert based in Clarus’ South San Francisco office, this is because dry AMD is “complex,” and there is no one easily discerned cause. Also, there are no reliable animal models for testing.
“You’d have to take a big bet to get human proof of concept data,” he said. A venture capital firm would be prone to waiting till a dry AMD startup was in the Phase 2 or Phase 3 stage before investing the $20 million to move toward full approval.
However, one research team based at Boston College and the University of Massachusetts Medical School in Worcester is trying to solve the problems of AMD and other eye diseases by creating nano-structured retinal implants. These are tiny devices placed in the eye to take the place of the malfunctioning rods and cones in the retina, explained Michael Naughton, a professor of physics at BC, whose team is working on the nanotechnology of the implant.
“The implant is designed to reconnect to the surviving cell circuitry and provide the electronic stimulus formerly provided by the rods and cones,” said Naughton. Ideally, these implants could have a form factor similar to contact lenses. They would be widely available, although requiring retinal surgery. “Until such a time as genetic engineering can cure or regenerate rods and cones, these artificial retinas could provide a viable path to restoring vision.” Potentially, the market is worth hundreds of millions of dollars annually, he estimated.
Currently, he estimates that he needs $42 million to pay for the prototype and the animal and human studies over the next 18 months. He said there are no implants on the market for consumer use at this time, though a number are in development.
Cunningham noted that for an investor, implants are an interesting area, but the key is getting compelling data that the technical risks associated with the device have been met, because it requires surgical implantation. Also, a startup must demonstrate the size of the market is big enough related to the cost of the device, he said.
Other firms working to treat AMD and other eye ailments include Lincoln, R.I.-based Neurotech Pharmaceuticals Inc., whose lead candidate NT-501 is an intraocular implant made of genetically modified human cells. In March, it released Phase 2 exploratory study data that indicated positive results in AMD treatment, with no “serious adverse events,” said Ted Danse, president and CEO of Neurotech.
Also, pSivida’s drug Iluvien is in Phase 2 trials for both forms of AMD, said Ashton. And New Haven, Conn.-based Optherion Inc. is developing a diagnostic service and drug platform for AMD. By year’s end, Optherion plans to file an independent new drug application (IND) submission to the U.S. Food and Drug Administration for its drug, said Colin Foster, CEO and president.
For the past several years, Bedford-based Resolvyx Pharmaceuticals Inc. has been evaluating its Resolvin inflammation control drug’s effectiveness against AMD, as well.
Sunday, April 26, 2009
National study is looking for Dry Macular Degeneration (AMD)patients for Landfall Eye Associates clinical trial
National study is looking for Dry Macular Degeneration (AMD)patients for Landfall Eye Associates clinical trial
April 16th, 2009
AMD patients who are interested to volunteer the Landfall Eye Associates study, will be reimbursed to cover study related transportation costs. Approximately four visits will be required of all participants.
It's a clinical study to determine if repetitive stimulation of the preferred retinal locus, the area near the central blind spot used to focus on words, letter, and object, will help in their ability to read.
The patients will be divided into two groups. One group of patients will use a medical device that looks like a computer screen and will display bright objects to stimulate the preferred retinal locus.
Participants must be able to perform the therapy twice daily for about 40 to 50 minutes each day, six times per week. The therapy will be performed in the participant’s home for approximately three months.
The other group is the control group, will not use the medical device or perform therapy. Participants will be randomly assigned to a group.
If the trial study shows the treatment with the medical device is effective, the participants who did not perform the therapy will be offered the opportunity to do so at a later date at no charge.
Source: WebWire
Landfall Eye Associates is participating in this multicenter national study sponsored by NovaVison, Inc., headquartered in Boca Raton, Fla.
April 16th, 2009
AMD patients who are interested to volunteer the Landfall Eye Associates study, will be reimbursed to cover study related transportation costs. Approximately four visits will be required of all participants.
It's a clinical study to determine if repetitive stimulation of the preferred retinal locus, the area near the central blind spot used to focus on words, letter, and object, will help in their ability to read.
The patients will be divided into two groups. One group of patients will use a medical device that looks like a computer screen and will display bright objects to stimulate the preferred retinal locus.
Participants must be able to perform the therapy twice daily for about 40 to 50 minutes each day, six times per week. The therapy will be performed in the participant’s home for approximately three months.
The other group is the control group, will not use the medical device or perform therapy. Participants will be randomly assigned to a group.
If the trial study shows the treatment with the medical device is effective, the participants who did not perform the therapy will be offered the opportunity to do so at a later date at no charge.
Source: WebWire
Landfall Eye Associates is participating in this multicenter national study sponsored by NovaVison, Inc., headquartered in Boca Raton, Fla.
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