Public release date: 8-Mar-2011 [ | E-mail | Share ] Contact: Deb Songdeb_song@rush.edu312-942-0588Rush University Medical Center

(CHICAGO) ? Physicians at Rush University Medical Center are testing a unique gene therapy product called CERE-120 to evaluate if its use can improve the symptoms of Parkinson’s disease. Rush is one of 11 sites in the U.S. and the only site in Illinois enrolling patients into the new, double-blinded trial.

CERE-120 is an experimental gene transfer drug being developed by Ceregene, inc. It contains the human gene for neuturin, a naturally occurring protein also known as a neurotrophic factor. Neurosurgery is used to deliver the neuturin directly to degenerating or dying dopamine neurons in the brain. In earlier studies, neuturin has shown to improve function and repair brain cells that degenerate in Parkinson’s disease.

“This gene therapy has the potential to improve the symptoms of Parkinson’s disease while also delaying further disease progression,” said Dr. Christopher Goetz, director of the Parkinson’s Disease and Movement Disorders program at Rush University Medical Center and site principal investigator of the study. “Patients with Parkinson’s disease urgently need therapeutic approaches that not only improve symptoms and function, but also to have the ability to favorably modify the underlying disease itself.”

Three previous trials demonstrated that CERE-120 was safe in 50 Parkinson’s disease patients who were followed for five years. Rush neurological researchers have been involved in all three trials.

“The preliminary data in the Phase I study are encouraging, and the first Phase II trial showed improvement in patients who were assessed under blinded conditions at 15-18 months post treatment,” said Goetz.

The new Phase IIb trial will test the efficacy of CERE-120 by delivering an increased dose of the gene therapy to two key areas of the brain called the substantia nigra and the putamen that are damaged by Parkinson’s disease. the goal of this new approach is to assure wider distribution of neurturin and increase the likelihood of repairing and protecting brain cells from further degeneration due to Parkinson’s disease.

Half of study participants will undergo surgery to receive a dosing of CERE-120. the other half will undergo a placebo surgery. a comparison between these two groups will help distinguish the effects of CERE-120 compared to those that receive placebo

If the study results demonstrate that CERE-120 administration is safe and beneficial, subjects who receive placebo surgery will have the option to have a second surgery to receive a dosing of CERE-120.

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The other centers participating in the study are Stanford School of Medicine, University of California San Francisco, Emory University, Mount Sinai Medical Center, Columbia University Medical Center, Beth Israel Medical Center, Duke University, University of Pennsylvania, Baylor College of Medicine, and University of Alabama at Birmingham.

Parkinson’s disease is a progressive disorder that leads to muscle stiffness, tremors and slowed movements and gait. It affects approximately one million people in the United States.

This study is partially funded by the Michael J. Fox Foundation for Parkinson’s Research.

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Public release date: 7-Feb-2011 [ | E-mail | Share ] Contact: Rachel Serokarseroka@aan.com651-695-2738American Academy of Neurology

ST. PAUL, Minn. ? People who spend more time in the sun and those with higher vitamin D levels may be less likely to develop multiple sclerosis (MS), according to a study published in the February 8, 2011, print issue of Neurology?, the medical journal of the American Academy of Neurology. MS is a chronic disease of the brain and spinal cord, usually with recurrent flare-ups of symptoms. It is often preceded by a first episode (or event) of similar symptoms lasting days to weeks.

“Previous studies have found similar results, but this is the first study to look at people who have just had the first symptoms of MS and haven’t even been diagnosed with the disease yet,” said study author Robyn Lucas, PhD, of Australian National University in Canberra. “Other studies have looked at people who already have MS?then it’s hard to know whether having the disease led them to change their habits in the sun or in their diet.”

The multi-site study involved 216 people age 18 to 59 who had a first event with symptoms of the type seen in MS. Those people were matched with 395 people with no symptoms of possible MS who were of similar ages, of the same sex and from the same regions of Australia.

The participants reported how much sun they were exposed to during different periods of their lives, and researchers also measured the amount of skin damage participants had from sun exposure and the amount of melanin in their skin. Vitamin D levels (from sun exposure, diet and supplement use) were measured by blood tests.

The risk of having a first event, diagnosed by a doctor, ranged from approximately two to nine new cases for every 100,000 people per year in this study. The reported UV light exposure of participants ranged from about 500 to over 6,000 kilojoules per meter squared. The researchers found that the risk of having a diagnosed first event decreased by 30 percent for each UV increase of 1,000 kilojoules. They also found that people with most evidence of skin damage from sun exposure were 60 percent less likely to develop a first event than the people with the least damage. People with the highest levels of vitamin D also were less likely to have a diagnosed first event than people with the lowest levels.

Studies have shown that MS is more common in latitudes further away from the equator, and this has been confirmed in Australia.

“Added together, the differences in sun exposure, vitamin D levels and skin type accounted for a 32-percent increase in a diagnosed first event from the low to the high latitude regions of Australia,” Lucas said.

Lucas noted that the effects of sun exposure and vitamin D acted independently of each other on the risk of first event. “Further research should evaluate both sun exposure and vitamin D for the prevention of MS,” Lucas said.

Lucas also stated that people should continue to limit their sun exposure due to skin cancer risks. she also noted that the risks of tanning beds far outweigh any possible protective effect against MS. Exposure to the sun has not been shown to benefit people who already have MS.

The study was supported by the U.S. National Multiple Sclerosis Society, the National Health and Medical Research Council of Australia, the ANZ William Buckland Foundation and Multiple Sclerosis Research Australia.

The American Academy of Neurology, an association of more than 22,500 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer’s disease, stroke, migraine, multiple sclerosis, brain injury, Parkinson’s disease and epilepsy.

For more information about the American Academy of Neurology, visit aan.com.

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Media Contacts: Rachel Seroka, rseroka@aan.com, (651) 695-2738 Angela Babb, ababb@aan.com, (651) 695-2789

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