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FROM: LA Times, Feb 17, 2005 Amgen Drug Is Said to Work A study says the trial Parkinson's treatment improved motor function, contradicting the company's research. By Denise Gellene, Times Staff Writer Just days after Amgen Inc. said it would stop supplying patients an experimental drug for Parkinson's disease, a research team from the University of Kentucky reported in a medical journal that the medicine worked in a clinical trial. Don M. Gash, an author of the study, said he hoped Amgen would reconsider its decision and provide the trial drug to 48 patients who participated in company-supported studies. Many of the patients have been lobbying Amgen for the drug, which they see as their only hope. "Controversy can be good if it can get people not to take a rigid position and not to create barriers," Gash said. Amgen spokeswoman Marie Kennedy said she was not aware of the study. Last week, Amgen said it would no longer provide the drug to patients because its studies showed that it did not work and might cause permanent harm. Kennedy said Wednesday that the company hadn't abandoned its research, and would continue to support laboratory studies of the drug by academics. The study, published in the Journal of Neurology, reported that 10 patients who had received the drug, known as GDNF, had an average 30% improvement in such areas as balance, gait and speed of hand movements. The study followed the patients for six months. However, seven of the 10 continued to receive GDNF for a full year before Amgen stopped providing the medication. Those patients further improved and saw a 45% increase in their motor function, Gash said. "It is the difference between being wheelchair-bound and being able to walk for several miles," he said. Researchers saw no signs of brain damage that Amgen observed when the company tested high doses of GDNF in monkeys, Gash said. The monkeys were given six times more drug than patients in the University of Kentucky study. "The difference between poison and medicine is the dose," Gash said. "The patients did very well and the side effect profile is excellent." The report said researchers could not rule out the so-called placebo effect in which the process of being treated, rather than the drug itself, causes patients to improve. An earlier Amgen-sponsored trial of 34 patients ended in disappointment. The company divided the patients into two groups — half received GDNF and the rest were in a control group given saline solution. At the end of six months, Amgen concluded that GDNF was no better than a placebo. But Gash said there were differences between the two studies that might explain the results. All patients received GDNF directly into their brains through tubes connected to pumps implanted in their abdomens. In the University of Kentucky study, the drug entered the brain in bursts through a catheter with 40 holes that Gash likened to a "soaker hose." Amgen used a catheter more like a garden hose that delivered the drug in a continuous drip. Gash said he has discussed his findings with Amgen scientists. "We certainly wish Amgen would reconsider," he said. http://www.latimes.com/business/la-fi-amgen17feb17,1,865660.story?coll=la -headlines-business&ctrack=3&cset=true --------------------------------------------------------------- Additionally a two year follow up of the Phase I study in Bristol, United Kingdom has been published in Annals of Neurology, February 2005 issue -- " Intraputamenal infusion of glial cell line-derived neurotrophic factor in PD: A two-year outcome study", Nikunj K. Patel, et.al and reports continued improvement in all 5 patients over the 2 years and no serious side effects. The authors concluded, that treatment with GDNF resulted in improvement in symptoms AND slowed the disease progression! "“Our results indicate GDNF’s potential as a therapeutic agent in PD, from its ability not only to provide symptomatic relief, but also to possibly modify the disease state, distinct from other current therapeutic strategies; however, continuing dopamine replacement therapy was required. The early onset of symptomatic improvement, accompanied by an increase in 18F-dopa uptake immediately surrounding the cannula tip, seems compatible with a functional upregulation in residual dopaminergic neurons. The progressive and sustained improvement in symptomology, and increased 18F-dopa uptake throughout the putamen at 24 months,15 is suggestive of reduced disease progression.” ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn