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FROM: WKYT 27 NewsFirst- Lexington, Kentucky http://www.wkyt.com/Global/story.asp?S=2712641 Parkinson's patients frustrated by end of trial LEXINGTON, Ky. -- A small group of Parkinson's disease patients in Kentucky are frustrated by a decision to stop a drug trial they say was reducing their symptoms and improving their lives. The 10 patients being treated at the University of Kentucky were given experimental doses of glial cell line-derived neurotrophic factor, or GDNF, to treat the progressive brain disorder. One of the patients, Dan Webster, said the drug helped him so much, he no longer needed a wheelchair. "I felt so good," he said. "The feeling of malaise went away, went far away." The trial was discontinued because of safety concerns and now Webster, 57, is gradually relapsing to his previous condition. "After 22 months of constant steady improvement, I have to move slow and slothlike again," Webster said. Unlike other drugs, which alleviate the symptoms, GDNF appeared to slow or even halt the progress of the disease itself, according to the UK study and in a similar study in Britain. In May, Dr. Byron Young, director of the Kentucky Neuroscience Institute at UK, told a group of neurological surgeons gathered in Orlando, Fla., patients in the UK study moved faster and had improved balance and better control of their movements. But in late June, Amgen Inc., the developer and patent owner of the drug, announced that an early analysis of a larger, Phase II GDNF study, conducted at several different sites around the country, "showed no clinical improvement compared to a placebo." Two months later, the drug company announced it was halting the study, and demanded that all patients immediately stop receiving GDNF. That has led some of the 10 patients in the UK study _ most of whom live in central and eastern Kentucky _ the five study participants in Britain and the 34 patients from the Phase II trial to band together in protest. They've set up a Web site to share testimonials about the positive effects of GDNF and are blanketing Amgen with letters asking that the company restart the study, or at least allow those who were in the study to take the drug. Roger Thacker, 65, of Versailles, said he went from constant stiffness and pain to driving tractors on his farm after a year on GDNF. "Things we forgot we dealt with before are coming back now," said his wife, Linda. Researchers at UK aren't giving up hope for GDNF either. "We think the drug really has a lot of promise," said Don Gash, chairman of UK's Anatomy and Neurobiology Department. But Amgen officials have said they're concerned that the drug is unsafe. Some monkeys suffered brain damage after receiving it and some human subjects developed antibodies to the drug, leading to fear that the antibodies might attack cells in other parts of the patients' bodies that naturally produce GDNF. The UK researchers think those hurdles might be overcome. "It's something that should be looked at, but at the present time we have no clinical grounds to say this should stop clinical use of these 10 patients," said Greg Gerhardt, director of UK's Morris K. Udall Parkinson's Disease Research Center of Excellence. Gash said it is "very common" for people to develop antibodies to protein drugs, but that those antibodies rarely cause a problem for patients. While the patients wait, they are being injected with saline to keep them from shutting down. "I'm back where I started from," since the GDNF stopped, said Jim Day, a 69-year-old Nicholasville resident who was diagnosed with Parkinson's 14 years ago. "I freeze up, I can't move sometimes." Webster, who installed water lines to his father-in-law's home last summer, is trying to figure out how he's going to gather the strength to fix the water pipes that burst in his Irvine home this week. "They're sentencing me to a life of pain and misery," he said. Website: www.gdnf4parkinsons.org ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn