The world’s biggest biotechnology firm, Amgen, has confirmed a previous decision to halt clinical trials of an experimental Parkinson’s disease drug, GDNF (glial-cell-lined-derived neurotrophic factor), after safety risks, including irreversible brain damage, were observed amongst trial patients [[29/06/04c]].
Amgen halted studies of GDNF last year when data suggested it could cause permanent harm, complicating an already devastating disease. As part of that decision, and based on thorough scientific review, Amgen has also decided to stop providing the product to the 48 patients who participated in the terminated clinical trials.
“We’ve looked at this decision from every perspective – scientific, medical and ethical… but we simply cannot allow trials to continue given the potential safety risks and the absence of proven benefit. Encouraging patients to continue in the GDNF study deters them from pursuing potentially helpful Parkinson’s disease therapies that are already approved and available,” said Kevin Sharer, Amgen’s chairman and chief executive. “Our desire is to actively pursue GDNF in a meaningful way that may benefit all Parkinson’s disease patients,” he added.
The company says it will continue to conduct additional research to better understand the potential of GDNF in the treatment of PD.