Age-related macular degeneration is growing with the graying American population

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."

FDA Approves Company's Clinical Trial Of hESCs- based Treatment for AMD

by: Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. (OTCBB: ACTC), a regenerative medicine company based in Marlborough, Mass., announced on January 3 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to treat dry age-related macular degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

ACT is now permitted to launch a Phase 1-2 multicenter clinical trial to treat patients with dry AMD, the most common form of macular degeneration in the world.

There are no treatments available for this prevalent disease of an aging global population. According to the company, dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

Age-Related Macular Degeneration has two predominant forms, wet and dry. Dry AMD is the most common form, accounting for almost 90 percent of all cases. The progress of dry AMD includes a breakdown or thinning of the layer of RPE cells in the patient’s macula, the region at the center of the retina responsible for high acuity vision. Over time, the progressive loss of RPE cells and accompanying loss of photoreceptors can cause severe vision loss and even blindness.

“ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine,” said interim CEO Gary Rabin. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques. We plan to proceed into the clinic with both of our hESC-based programs as quickly as possible.”

The Phase 1-2 trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites. Sites currently under consideration are the Jules Stein Eye Institute at UCLA, and the Ophthalmology Department at Stanford University School of Medicine. Additional sites may be considered.

“Dry AMD is the leading cause of blindness in individuals over the age of 55,” said Robert Lanza, M.D., chief scientific officer. “As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need. Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells. Because only a small number of cells (50-200K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well. Based on our animal model studies, we are very excited about the opportunity to treat patients. In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects. We have also maintained near-normal function in a mouse model of Stargardt’s Disease, a form of juvenile macular degeneration. In addition to this trial, we plan to concurrently use our RPE cells in our Phase I/II Clinical Trial for Stargardt’s Disease, which received the green light from the FDA in November. We hope to see a similar benefit in both Stargardt’s Disease and Dry AMD patients.”

ACT’s dry AMD therapeutic program uses RPE cells derived from hESCs to replace the lost RPE cells in the patient’s eyes. ACT’s proprietary RPE cell manufacturing process is protected by a number of broad patents, as is the use of hESC-derived RPE cells for treating macular degeneration. While the initial portion of the clinical trial will focus on safety, in subsequent clinical trials the company hopes to demonstrate that the RPE cells injected into the retinal space will be capable of slowing or halting progression of the disease, and potentially even restoring some visual acuity to patients.

“It is estimated that over ten million Europeans suffer from age-related macular degeneration, representing a vast unmet need and a significant market opportunity,” commented Edmund Mickunas, vice president of regulatory affairs. “We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe.”

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

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.

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."

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.

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.

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.

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.

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.

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."

Macular Degeneration and Heavy Metals

By Jannette Barrett

What Is Macular Degeneration?

Macular Degeneration is a condition that affects the macula part of the retina of the eye resulting in a disturbance to central vision. Although the exact etiology of the disease is unknown, it is believed that deterioration of the retina leads to a breakdown in the transmission of signals to the brain from the nerves and receptors of the eye. When the signals are unclear, the brain cannot correctly interpret the information it receives and there is a loss of the detail that allows us to read, recognise people, perform manual work or manage fine tasks such as threading a needle. A person with macular degeneration may experience blurred or decreased central vision, blind spots, wavy lines instead of straight and size distortion.

There are two types of macular degeneration, wet and dry.

The onset of wet macular degeneration occurs when abnormal blood vessels, which have grown under the centre of the retina, bleed or leak and scar the retina. Macula damage may occur rapidly. It is not uncommon for wet macular degeneration to start in one eye and effect the other at a later time.

Dry macular degeneration, which is the most common form, results from a gradual breakdown of cells in the macula leading to blurring of central vision. The onset of dry macular degeneration can be detected early by an optometrist because of the presence of small, yellowish spots, called drusen, at the back of the eye. However, people who have drusen, may not have visual impairment or related symptoms. When dry macular degeneration advances due to damage to the retina and nerves, vision loss will occur.

Macular degeneration is treated by laser surgery, photodynamic therapy where a drug is injected that destroys newly formed, abnormal blood vessels or injections, however, none of these treatments can restore the vision that has already been lost.

Risk factors

There are a number of identified risk factors associated with AMD. Family history and age are thought to be the most common risk factors. People with outdoor occupations and continuous exposure to sunlight may also be at risk, particularly if their skin is lightly pigmented. Women seem to be at a greater risk than men. There are also environmental and behavioural factors such as smoking and obesity. Research cited below shows that a build up of toxic heavy metals can damage eye health.

Research

The National Institute of Health and the National Eye Institute in the US, published the results of a random study of people with moderate and advanced AMD in the Archives of Opthalmology in 2001, entitled the Age-Related Eye Disease Study. The study reported that a significant slowing of disease progression and preservation of sight could be achieved by taking dietary supplements containing high-dose antioxidants and zinc.

Research published by Erie et al in 2005 in the American Journal of Opthalmology, measured the concentration of toxic heavy metals in the fluids and tissues of human eyes. Concentrations of lead, cadmium, mercury, and thallium in ocular tissues, ocular fluids, and blood were found in the autopsy of 30 eyes from 16 subjects. The study concluded the presence of lead and cadmium which had accumulated in the tissues and retinal pigment epithelium and choroid. Further study into the toxicity of these heavy metals and their possible role in eye disease was recommended.

What Can We Do?

In addition to the medical treatments mentioned above, there are a number of common sense things we can do to help prevent the onset of macular degeneration.

In order for high-dose antioxidants and zinc to be effectively absorbed into the body and to protect the eyes from heavy metals, it is firstly essential to detoxify the body. Published clinical trials have shown that when removing heavy metals and toxins, including pesticides and herbicides from the body safely and effectively, supplements will be more readily absorbed, the immune system may function more efficiently and normal blood pressure may be more easily maintained. Eating a healthy diet, including green leafy vegetables and fish, is also essential to good eye health. A healthy diet will help with weight control as will some regular exercise. Giving up smoking is critical for eye health.

Some people also believe in the benefit of eye exercises to increase eye health. Firstly move the eye slowly from side to side, then from top to bottom a few times. Move the eyes in a circular motion, then reverse a few times. Finally, raise your finger level with your nose and focus there for a time, then focus on something in the distance.

Remember the most important step, to take a daily detoxifying shower on the inside to give your eyes the maximum chance for sustained health. Your body will love you!
Author Resource:- Jannette has researched health and well being issues for the past 20 years and holds a Bachelor of Applied Science in Health Promotion. Healthy eating, regular meditation, moderation in everything and taking the correct supplements can make an enormous improvement to the quality of our lives.

The Best 9 Omega-Fish Oil Benefits

“A huge amount of studies show that, not only are the benefits of fish oil numerous, many of them are really very amazing! It seems sometimes like new research is being produced all the time, as researchers and physicians learn even more about how and why it is indeed effective. The omega-3 fatty acids found in fish oil are “good fats” that are vital to health. They are crucial for our health but our bodies can’t produce them – you have to get them through diet.

Here are some proven fish oil health benefits that should convince you to eat more oily, wild-caught fish and begin taking a highly refined fish oil supplement in the event you’re not at present!

Reduces Pain & Inflammation

Omega-3s possess a great anti-inflammatory impact. Research trials suggest that diets rich in omega-3s (and low in the pro-inflammatory omega-6s) may benefit people with inflammatory conditions — anything that ends in -itis!. Omega-3 additionally has been used to effectively treat neck, back and menstrual pain, allowing study patients to cut down their particular consumption of NSAID medication.

Promotes Heart Wellness & Protects Against Heart Attack and Strokes

Fish oil continues to grow in research reputation as a key promoter of heart health. According to the American Heart Association, fish oil is effective in lessening the incidence of heart disease and aids in reducing risk factors such as high cholesterol and high blood pressure. Research studies of heart attack survivors have discovered that daily fish oil capsules drastically minimize the risk of death, additional heart attacks and stroke. Omega-3s also reduce blood triglycerides, help correct irregular heartbeats, and can help prevent and treat atherosclerosis by preventing the formation of plaque and blood clots, which typically clog arteries.

Ensures Healthy Joints and Reduces Arthritis Symptoms

The omega-3 fatty acids in fish oil reduce tenderness in joints, pain intensity and morning stiffness caused by rheumatoid arthritis. In fact, several test tube studies have shown that omega-3s actually lessen the action of enzymes that break down cartilage. More than 13 published research trials have shown that fish oil supplements are very effective at treating rheumatoid arthritis. Fish oil has helped those suffering from RA to reduce their need for pain medicine.

Supports Happy Mood & Emotional Wellness

In nations where fish makes up a significant part of the diet, nationwide rates of depression are lower. So, it’s not surprising that studies have shown that fish oil capsules can alleviate the symptoms of depression, bipolar disorder and psychosis. Numerous clinical trials have found that participants that took omega-3s in addition to prescribed anti-depressants had a larger improvement in symptoms than those who only took antidepressants, with subjects experiencing a stabilizing effect and less mood swings. Studies have also demonstrated that, when prisoners were administered omega three fatty acids, there was a significant drop in hostile behavior. Omega-3s also appear to lower the risk ofpostpartum depression.

Enhances Mental Focus & Long-Term Cognitive Functioning

Did you know that omega-3s, especially DHA, are highly concentrated in our brains? They’re important for optimal cognitive (brain memory and performance) and behavioral function, as well as normal growth and development. Studies demonstrate that omega-3s may help in maintaining adequate cognitive functioning and possibly in avoiding or delaying the onset of Alzheimer’s disease. We also now know it’s incredibly necessary that pregnant women get adequate DHA, which is required by the developing fetus — during the third trimester of being pregnant, the brain of the fetus grows at a rate of a quarter million new neurons every 60 seconds! Children are also aided by omega-3 intake, as many studies show that omega-3s enhance learning, concentration, reading and vocabulary skills. Countless studies have even shown benefits in treating ADD.

Promotes Vision Wellness

Studies show that people with a greater omega-3 consumption appear to have a decreased risk of Dry-Eye Syndrome and developing AMD, or age-related macular degeneration. Early research also shows that fish oil supplements aid in lessening dry eye symptoms, may help to slow macular degeneration for those already developing it and improves ocular health in general.

Pregnancy, Infant Brain/Vision Development & Reduced Incidence of Childhood Disorders

DHA makes up 15-20% of the cerebral cortex and approximately 30-60% of the retina, so it’s absolutely necessary for normal growth and development of the fetus and baby. Prenatal DHA availability also seems to reduce the chances of childhood allergies and have an effect on motor skill quality, cognitive development and hyperactivity/behavior later in the child’s life. Omega-3s also assist in reducing the risk of low birth weight and premature birth.

Enhances Metabolism of Fat and Weight Loss

According to the National Institute of Health, omega-3s transmit “I’m full” signals to the brain and help quash hunger signals. Research has also shown that omega-3 fish oil improves the effectiveness of exercise in reducing weight. Volunteers who were alloted fish oil with their diet showed greater weight loss as compared to those who didn’t consume fish oil. Exercise along with fish oil had a positive effect on the body shape and body composition of the volunteers. Reduces Risk of Prostate, Breast & Colorectal Cancers Though more research in this area is certainly needed, we now know that the omega 3’s that appear in fish oil assist in the prevention and treatment of testicular, prostate, breast and ovarian cancers. Preliminary studies suggest that taking fish oil everyday can help inhibit the progression of colon cancer in people with early stages of the disease and may even have the capacity to cause apoptosis (cellular death) of cancer cells.

More can be written with regards to the many fish oil benefits. And, as the scientific community and doctors continue to examine omega-3s, you can bet that fish oil will keep making headlines as the ideal source of these essential fatty acids that are so essential to our bodies. Even if you’re currently in great health, a quality fish oil supplement is the fastest, safest way to realize and maintain optimal health!”

Artificial Retina offers new Hope

TUCSON - There is new hope for millions of people losing their vision. Many are going blind because of age-related macular degeneration and other conditions. But a new device called Artificial Retina has people seeing and believing.

Dean Lloyd is one of 14 people in the United States seeing through an Artifical Retina. He lost his vision in 1974. Lloyd says, "I almost lost all my vision in six months." Then in 2007, after a three hour operation, his sight, though limited, returned. "The beauty of the human brain is when you've had sight at one time, the brain seems to save the images," he said.

The camera on Dean's glasses captures an image and sends it wirelessly to an implant in his eye that stimulates his optic nerve to create an image in his brain. The next generation for Dean's implant is one that could help him see details and faces.

Satinderpall Pannu heads the Artificial Retina project at Lawrence Livermore labs in California. Starting with a silicon wafer and a thin coating of polymer, the disk is processed, electrodes are added and the implant is encased in titanium and gold, "It's a very rewarding feeling. It's amazing to me that technology that we've developed here at the lab can actually restore someone's sight," Pannu said.

Pannu says in 10 years, 50 million people in the world will suffer from blindness that these implants could reverse, "We really would like to take this tech to have a digital camera embedded in your retina and be able to restore your vision completely."

The only clinical trials for the artificial retina in the U.S. are run through a California Company "Second Sight."

Project leaders at Lawrence Livermore say they only have funding through next year. Right now, they're trying to lobby congress to extend the project's 8-million dollar a year budget, to improve the implant.

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.

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

Researchers create retina from embryonic cells

By Adrian Galbreth

Researchers in the US have successfully created a retina from human embryonic stem cells, which offers hope to millions with degenerative eye disorders.

Experts at the University of California Irvine created an eight-layer, early stage retina from human embryonic stem cells, which is the first ever three-dimensional tissue structure to be made from stem cells.

Study leader Hans Keirstead of the Reeve-Irvine Research Center and the Sue and Bill Gross Stem Cell Research Center at the facility, said the process also marks the first step towards the development of transplant-ready retinas to treat conditions such as retinitis pigmentosa and macular degeneration, a leading cause of blindness.

"We made a complex structure consisting of many cell types. This is a major advance in our quest to treat retinal disease," he explained.

Recently, German research centre Fraunhofer-Gesellschaft claimed that a new implant made of plastic could soon offer patients the chance to see again without having to wait for cornea transplants.ADNFCR-1853-ID-19804594-ADNFCR

The Aging Eye: Researchers Aim To Stop the Clock

By JANE E. BRODY

AGING Americans expect more from their eyes these days than ever before. People in their 70's and 80's want to be able to drive, play cards, recognize people on the street, travel with their grandchildren, take advantage of senior discounts in the movies and read the books they missed while working full time.

But eyes have a way of aging that can render such expectations unrealistic. Far worse than the loss of visual acuity that prompts most middle-aged people to resort to magnifying lenses are sight-robbing diseases like glaucoma, cataracts, age-related macular degeneration, diabetic retinopathy and other retinal disorders that afflict tens of millions of Americans, usually after age 50.

The incidence of such potentially blinding disorders is increasing rapidly as the number of older people grows. Experts predict, for example, that by the year 2030, 6.3 million older Americans will develop macular degeneration, up from 1.7 million in 1995. It is a still-irreversible disorder that robs people of the central vision needed to drive, read, watch television, recognize faces, play cards or do any fine work. If Grandma Moses had had macular degeneration, her artistic talents would never have been noticed.

Fortunately, research is progressing on a number of promising new treatments, including low doses of radiation, and a combination of lasers and light-activated chemicals, both of which are used for some particularly hard-to-treat forms of macular degeneration. Other research is concentrating on how to stop toxins that damage the eye in glaucoma, and the genetics of several different eye diseases.

''Older Americans today expect to enjoy their retirement with the same visual capacity that they had in their younger years,'' said Dr. Harold Spalter, professor of ophthalmology at Columbia-Presbyterian Medical Center in New York. But, alas, as was apparent at a four-day seminar that Dr. Spalter chaired here last month, researchers are still a long way from knowing how to reverse most blinding eye disorders.

Still, major progress in understanding and treating these conditions -- and perhaps detecting them early enough to blunt their effects -- was evident at the seminar, organized by Research to Prevent Blindness, a New York-based voluntary organization. Unfortunately, though, many elderly Americans cannot afford the early detection procedures described at the seminar because Medicare and many other insurance programs do not cover such preventive measures.

For example, while insurance companies would routinely cover a visual field examination for a patient who already has glaucoma, most would not pay for this test for a person who has not yet experienced vision loss, when the disease process might be stopped without lasting vision damage.

Furthermore, an ongoing study of 2,520 men and women aged 65 to 84 in Salisbury, Md., has revealed that the usual eye chart test for visual acuity is inadequate to assess vision losses that interfere with the ability of elderly people to get around on their own, perform tasks of daily living and avoid accidents that can result in serious or fatal injuries. Rather, Dr. Sheila West, professor of ophthalmology at Johns Hopkins Medical Institutions, reported that tests for contrast sensitivity -- the ability to distinguish, say, a step from the one below it -- are more revealing of functional disability in older people.

''We have found that loss of contrast sensitivity is as important as arthritis and heart failure in determining loss of mobility in the aged,'' Dr. West said. She traced this loss to ''nonspecific retinal changes'' and the beginnings of cataracts, a gradual clouding of the lens of the eye that eventually obscures vision. However, early-stage cataracts are rarely recognized by those who have them and are often dismissed as inconsequential by eye doctors.

Sunlight, Dr. West said, is a major factor in the formation of cataracts, and the damage is cumulative. By assessing the exposure of study participants to sunlight, Dr. West and colleagues determined that for every 1 percent increase in exposure to ultraviolet-B light, the risk of developing cataracts rose by 10 percent.

''There is no threshold for sun-related damage, the dosage is cumulative and no group is immune to it,'' Dr. West said the study showed. She recommended that when out of doors, everyone -- starting in childhood -- should wear lenses that block ultraviolet light and a cap with a brim that shades the eyes.

Dr. M. Cristina Leske, head of preventive medicine at University Medical Center in Stony Brook, N.Y., and associates, identified other risk factors for cataracts. Through a five-year study of 764 patients, they found that Caucasians are three times as likely as blacks to develop cataracts. Those who take the gout medicine allopurinol face more than a two-fold increase in risk, and smokers have a 60 percent increase.

On the other hand, certain nutrients appear protective. The risk was 30 percent lower among those who took multivitamin-mineral supplements and nearly 60 percent lower among those who took a vitamin E supplement, a finding that is now being tested in a clinical trial sponsored by the National Eye Institute. Still another study of 247 women aged 56 to 71 conducted at Tufts University in Boston found that taking vitamin C supplements for more than 10 years reduced the risk of early cataracts by 77 percent and the risk of moderately advanced cataracts by 83 percent.

But while cataracts can usually be treated very successfully by surgically removing the damaged lens and replacing it with a synthetic lens implant, age-related macular degeneration, the leading cause of legal blindness in the elderly, has yet to yield to an effective treatment. Macular degeneration involves progressive damage to the cells in the center of the retina that are responsible for straight-ahead vision.

Early cases are often treated with lasers, which have the unfortunate side effect of destroying normal retinal cells as well as the damaged areas beneath them. Furthermore, after laser treatment, the vision-damaging tissue often grows back.

Dr. Dennis M. Marcus, an ophthalmologist at the Medical College of Georgia in Augusta, said that laser therapy usually cannot be used for the most severe form of the disease -- so-called wet macular degeneration, which involves the growth of leaky blood vessels beneath the central retina. Instead, he and his colleagues are testing low-dose radiation to destroy the blood vessels but spare the normal retinal cells. Thus far, 100 patients have been treated in a clinical trial that will eventually involve 500 people with wet macular degeneration. While it is too soon to evaluate the effectiveness of the treatment, Dr. Marcus said that he has seen no radiation-induced complications.

Another clinical study is testing a technique called photodynamic therapy. It starts with the intravenous administration of a photosensitive dye that collects in the damaging blood vessels that are growing beneath the retina. The eye is then exposed to laser light that activates the dye, destroying those vessels only. Dr. Joan W. Miller, an ophthalmologist at the Massachusetts Eye and Ear Infirmary, said that preliminary studies showed that the technique effectively closes off the leaky vessels in the majority of patients. And while these vessels reopen and leak in some patients, the treatment can be repeated, if needed, without harm to the eye.

Some seminar participants said the best hope for conquering blinding eye diseases was unraveling the sometimes complex genetics underlying many if not all of these conditions. Just last month, for example, a team of scientists announced the discovery of the first genetic link to age-related macular degeneration, which strikes 25 percent of Americans over the age of 65 and is the major cause of vision loss in the elderly. The researchers hope that by studying mutations in this gene they will gain an understanding of how the disease damages the eye, a means of identifying those at risk and methods of prevention and treatment.

Glaucoma, for example, usually involves elevated pressure inside the eye, leading eventually to the death of ganglion cells, the nerve cells that transmit information from the eye to the brain. This disease afflicts perhaps eight million Americans and causes blindness in 5,500 each year. Currently the only available treatment involves continual use of eye drops that reduce intraocular pressure. This only works if treatment is begun early.

Dr. Robert W. Nickells, an eye researcher at the University of Wisconsin in Madison, said, however, that ''new advances suggest that glaucoma could be treated during the second or even the third stage of the disease.'' The second stage involves the release of high concentrations of ''excitotoxins,'' amino acids that are toxic to nerve cells. Dr. Nickells said that several compounds that intervene in the formation of excitotoxins have been developed to treat other neurodegenerative disorders and may also prove useful in treating glaucoma.

As for the third stage, he and his colleagues have found in monkeys and rodents that ganglion cells succumb to a form of programmed cell death that appears to be controlled by three genes that act as a molecular switch. One of the genes, called bcl-x, prevents the fatal blow and might be harnessed therapeutically to override the cell death mechanism, Dr. Nickells said.

But discoveries about the genetics of eye disorders can sometimes raise more questions than they answer. For example, Dr. Fulton Wong of Duke University Medical Center reported that as many as 50 genes are believed to be involved in the progressive disease retinitis pigmentosa, which begins as night blindness and loss of peripheral vision and eventually destroys central vision, leaving people blind. Thus far, four genes have been identified, each with multiple mutations that may result in different aberrations of the condition. One of the genes that codes for the production of the visual pigment rhodopsin can exist in 92 different mutated forms, Dr. Wong reported.

This year alone, three genes for various forms of glaucoma have been identified. But Dr. Janey Wiggs, an ophthalmologist and geneticist at Tufts University School of Medicine in Boston, said: ''This is a very complicated disease, with maybe 20 or 30 genes involved. And finding genes is only the first step. Where and when is the gene required and how does it produce disease? Does it result in too much or not enough of a gene product or make a toxic product?''

Still, she and others expressed guarded enthusiasm for the prospects of gene therapy to treat various devastating eye diseases. ''The eye is accessible,'' she said. ''It can be given selective treatment, using the other untreated eye as a control to see how well the treatment is working.''

Dr. J. Timothy Stout, head of the division of ophthalmology at Children's Hospital in Los Angeles, said, ''The potential use of gene therapy is nearly limitless for the ophthalmologist.'' He and his colleagues are exploring in animals the potential of a so-called suicide gene to treat eye diseases that involve excessive cell division, such as intraocular proliferative disease, macular degeneration and diabetic retinopathy. Normally, most cells in an adult eye are not dividing. Using as a gene carrier a virus that infects only actively dividing cells, he introduces into the eye a gene that by itself is not toxic but that results in cell death when combined with the drug ganciclovir, which also does not harm normal cells. Thus, the treatment is specific for the proliferating cells involved in the eye disease.

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.

Functional annotation of the human retinal pigment epithelium transcriptome

Functional annotation of the human retinal pigment epithelium transcriptome


To determine level, variability and functional annotation of gene expression of the human retinal pigment epithelium (RPE), the key tissue involved in retinal diseases like age-related macular degeneration and retinitis pigmentosa. Macular RPE cells from six selected healthy human donor eyes (aged 63-78 years) were laser dissected and used for 22K microarray studies (Agilent technologies).

Data were analyzed with Rosetta Resolver, the web tool DAVID and Ingenuity software.

Results: In total, we identified 19,746 array entries with significant expression in the RPE. Gene expression was analyzed according to expression levels, interindividual variability and functionality.

A group of highly (n=2,194) expressed RPE genes showed an overrepresentation of genes of the oxidative phosphorylation, ATP synthesis and ribosome pathways. In the group of moderately expressed genes (n=8,776) genes of the phosphatidylinositol signaling system and aminosugars metabolism were overrepresented.

As expected, the top 10 percent (n=2,194) of genes with the highest interindividual differences in expression showed functional overrepresentation of the complement cascade, essential in inflammation in age-related macular degeneration, and other signaling pathways. Surprisingly, this same category also includes the genes involved in Bruch's membrane (BM) composition.

Among the top 10 percent of genes with low interindividual differences, there was an overrepresentation of genes involved in local glycosaminoglycan turnover.

Conclusions: Our study expands current knowledge of the RPE transcriptome by assigning new genes, and adding data about expression level and interindividual variation.

Functional annotation suggests that the RPE has high levels of protein synthesis, strong energy demands, and is exposed to high levels of oxidative stress and a variable degree of inflammation. Our data sheds new light on the molecular composition of BM, adjacent to the RPE, and is useful for candidate retinal disease gene identification or gene dose-dependent therapeutic studies.

Author: Judith C Booij, Simone van Soest, Sigrid MA Swagemakers, Anke HW Essing, Annemieke JMH Verkerk, Peter J van der Spek, Theo GMF Gorgels and Arthur AB Bergen
Credits/Source: BMC Genomics 2009, 10:164