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news.Amgen has confirmed its decision to halt clinical trials of its experimental Parkinson's disease drug, GDNF, after scientific results indicated that the drug could potentially cause permanent harm.
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As part of that decision, Amgen has also concluded that it will not provide GDNF (glial-cell-lined-derived neurotrophic factor) to the 48 patients who participated in clinical trials that were terminated in the fall of 2004.
The potential safety risks observed in preclinical studies included irreversible brain damage as well as an absence of medical benefit.
“We’ve looked at this decision from every perspective – scientific, medical and ethical. Our hearts truly go out to trial patients and their families, but we simply cannot allow trials to continue given the potential safety risks and the absence of proven benefit,” said Kevin Sharer, Amgen’s chairman and CEO.
“Encouraging patients to continue in the GDNF study deters them from pursuing potentially helpful Parkinson’s disease therapies that are already approved and available,” he concluded.
Amgen said, however, that it will continue to support GDNF by continuing to conduct additional research to better understand the potential of the treatment in Parkinson’s disease.