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(GDNF - University of Kentucky) Study Shows Effectiveness Of Experimental Parkinson's Drug BY KARLA WARD Lexington Herald-Leader / Macon Telegraph, GA Posted on Fri, Jun. 04, 2004 LEXINGTON, Ky. - (KRT) - Early results of a small University of Kentucky study indicate an experimental drug might improve treatment of Parkinson's disease. Parkinson's is a progressive brain disorder characterized by shaking, slow movement and muscle stiffness. While currently available drugs mainly relieve the symptoms, this therapy might halt progress of the disease. In a study that began in March 2002, 10 patients with the disease have been treated with glial cell line-derived neurotrophic factor, or GDNF, a growth factor that is naturally present in low levels in the adult brain. Twenty-four weeks into their treatment, an evaluation found that motor function had improved 30 to 40 percent for the six patients who have since completed the trial, Dr. Byron Young, co-author of the study, said yesterday. Young is director of the Kentucky Neuroscience Institute at UK. The patients had improved balance and better control of their movements. They also moved faster. The improvements lasted four weeks after they stopped receiving GDNF. Young outlined the findings at the American Association of Neurological Surgeons annual meeting in Orlando last month. Despite optimism about GDNF, the UK researchers are keeping a low profile. They caution that the drug needs more testing to become a viable treatment, and that could be years away. "One must use caution in interpreting a small, uncontrolled study," Young said. "Obviously we're excited about this and hope that this is going to be an important contribution, but it's too early to tell." The researchers declined to discuss their results in more detail while they wait for a scientific journal, which they didn't identify, to review their findings for publication. Publication lends credibility to a study's results. The preliminary results of the UK study - as well as a similar study published last year in Nature Medicine - are "extremely important and exciting," said Michael Zigmond, professor of neurology at the University of Pittsburgh. Unlike the drugs currently available for Parkinson's - some of which seem to slow the progression of the disease - GDNF might be able to stop and reverse its progression, said Zigmond, who did not participate in either study. GDNF appears to help regrow certain brain neurons, destruction of which is thought to cause such Parkinson's symptoms as stiff limbs. Amgen Inc., the company that developed and controls a form of GDNF, is conducting a larger, phase II clinical trial at multiple medical centers to study the drug further, but UK is not participating. Experimental drugs must complete three phases of clinical trials to receive approval from the U.S. Food and Drug Administration. The UK team is still completing its initial study on some of its patients, who all had moderate to severe Parkinson's Disease and had exhibited symptoms for four to 15 years. Nine of the 10 patients will finish by October. Young noted that findings in studies such as UK's - funded by a $5 million grant from the National Institute of Neurological Disorders and Stroke - are sometimes contradicted by larger studies. Besides involving a very small number of people, the research was focused primarily on evaluating the safety of the treatment and finding the best dosage, as is typical at this stage of the process. GDNF's effectiveness was a secondary concern. The patients' outcomes also could have been influenced by a "placebo effect," in which improvements are related to their expectations regarding the treatment, said Greg Gerhardt, a member of the research team and director of UK's Morris K. Udall Parkinson's Disease Research Center of Excellence. And Zigmond said the method UK used to deliver the drug would not be practical for the general population of Parkinson's patients, who number as many as 1.5 million in the U.S, according to the National Parkinson Foundation Inc. In both the UK study and a similar study conducted in Wisconsin and Great Britain, GDNF is infused directly into the part of patients' brains where Parkinson's originates. The drug flows through a catheter that runs from a pump implanted in the abdomen. Other possible methods are also being studied. Despite mentioning "general discomfort" from the pumps, Young said, all six patients who have finished the UK trial have opted to keep them in and continue receiving GDNF. "The safety profile is really encouraging," said Don Gash, another member of the research team and a professor in the anatomy and neurobiology department. --- SOURCE: Lexington Herald-Leader / Macon Telegraph, GA http://www.macon.com/mld/macon/news/nation/8843198.htm * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn