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PDF Requests the Amgen Corporation to Offer Reinstatement of GDNF to Patients Who Have Been Participating in Recent Clinical Trials of GDNF as a Potential Treatment for Parkinsonís Disease
- Feb 06 2005
A Resolution of the Board of Directors of the Parkinsonís Disease Foundation Thursday, January 27, 2005
The Parkinsonís Disease Foundation (PDF) supports the view that GDNF, a neural growth factor, is potentially useful for the treatment of Parkinsonís disease and urges further investigation to explore and resolve the issues of safety and efficacy that have been raised in clinical trials to date.
In the meantime, the PDF supports the request of trial participants who wish to continue testing GDNF with full awareness of any concerns there may be about safety, and requests the Amgen Corporation, the manufacturer of GDNF, to make the product available for continued testing to those trial participants and their physicians who:
(i) request it;
(ii) are prepared to sign appropriate waivers that will hold Amgen harmless in the event of complications and adverse effects, whether known or unforeseen, and whether they occur now or at any time in the future; and,
(iii) promise to provide continuing data to Amgen on the patientsí experience with GDNF that will enable scientists and regulatory authorities to monitor the safety, tolerability and efficacy of the treatment.
New York City, January 31, 2005
Source Date: Feb 06 2005