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The preliminary hearing for the lawsuit by 8 Un. of Kentucky GDNF trial participants will take place Tuesday morning in Lexington Kentucky. There is an online petition in support of reinstating treatment for the trial participants. To sign it see: http://www.plwp.org/gdnfpetition2005.htm and to read their stories see: www.gdnf4parkinsons.org Lexington Herald Leader Posted on Sat, Jul. 02, 2005 Researchers: Parkinson's drug was effective IT GAVE HOPE IN UK TEST BUT WAS WITHDRAWN ASSOCIATED PRESS WASHINGTON - A drug withdrawn from clinical trials because of safety concerns was helping regrow nerve fibers in the brain of a man with Parkinson's disease, scientists report. The finding will probably renew debate over the drug, GDNF, which had been tested at the University of Kentucky. The drug had offered encouragement to people with Parkinson's. But this year, the drug was withdrawn by the manufacturer, Amgen, which cited safety concerns. Eight Kentuckians with Parkinson's who received GDNF through testing at UK filed a federal lawsuit against Amgen last week in U.S. District Court in Lexington, seeking to get the drug back. They claim in the lawsuit that Amgen was negligent, broke a contract and breached its promises by taking GDNF away. They say that many or all of their symptoms improved while they were on the drug, and that without it they are reverting to their previous states. All four UK researchers overseeing the study have provided affidavits supporting the lawsuit. Two other patients, neither of whom was from Kentucky, sued Amgen this year, but a federal judge in New York turned them down in June. Seth Love, Steven S. Gill and colleagues at Frenchay Hospital in Bristol, England, report in Monday's issue of the journal Nature Medicine that an autopsy of the brain of one of the patients who received the drug in an early trial shows that nerve fibers that were lost to the disease were growing back. The patient, a 62-year-old man, died of a heart attack. In Parkinson's, brain cells that produce the chemical dopamine, crucial for brain cell communication, are destroyed. The result is symptoms such as trembling in hands, arms, legs, jaw, and face; rigidity or stiffness of the limbs and body; slowness of movement; and impaired balance and coordination. GDNF, which stands for "glial cell line-derived neurotrophic factor," is a natural growth agent needed by brain cells to produce dopamine. The autopsy shows "for the first time" that infusion of GDNF into a portion of the brain called the putamen causes regrowth of nerve fibers, Love reported. Andrea Rothschild, a spokeswoman for Thousand Oaks, Calif.-based Amgen, said the company was not surprised by the finding. "It's not clear that you can attribute that neural growth to any kind of clinical outcome," she said. ------------------------------------------------------------------------- ------- Herald-Leader staff writer Karla Ward contributed to this report ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn