New York, February 11 The following statement is being released by the Parkinson's Disease Foundation, located at 710 West 168th Street, New York City. It follows the announcement, earlier today, of a decision by Amgen Incorporated, manufacturer of GDNF, an experimental neural growth factor, to forgo the offer of reinstatement of GDNF to patients who were involved in recent clinical trials of the treatment. The authors of the PDF statement are Stanley Fahn, M.D., the Foundation's Scientific Director, and Robin Anthony Elliott, its Executive Director.

"The Amgen announcement, which followed a resolution by the PDF Board of Directors urging the company to permit patients who participated in the company's clinical trials the option of continued access to GDNF, is deeply disappointing to PDF, to the Parkinson's community, and to the participating patients," the statement reads. "However well-intentioned the company may have been in wrestling with this issue, we believe it has reached the wrong decision whether judged in terms of science, or the desires of the people who participated in the clinical trials, or the issues of safety."

"In terms of the science, we would argue that the reinstatement of GDNF, if accompanied by the continuing collection of efficacy and safety data, would enable scientists and regulatory authorities to monitor the long-term aspects of safety and efficacy of the treatment. Furthermore, the observation of increased fluorodopa uptake in PET scans needs to be carefully followed over time to determine if this will eventually translate into clinical improvement. Giving up this opportunity to learn is, in our view, a mistake."

"In good faith, the 48 patients who participated in the clinical trials invested their time and indeed their lives in helping to test the efficacy and safety of GDNF. This trophic factor has long been viewed by scientists as a potentially beneficial treatment to slow and possibly reverse the
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Contact: Christiana Evers
cevers@pdf.org
Parkinson's Disease Foundation
11-Feb-2005

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