Amgen announces start of GDNF trial in Parkinson's disease.

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Aug. 12, 1996--Amgen (NASDAQ:AMGN) Monday announced that it has begun the first human clinical trial of its novel neurotrophic factor Glial Cell Line-Derived Neurotrophic Factor (GDNF) in people with Parkinson's disease.

The initial trial is designed primarily to evaluate the safety and tolerability of GDNF in patients with moderate to severe Parkinson's disease. The trial is being conducted at multiple Parkinson's disease treatment centers in North America and will be approximately 12-15 months in duration.

Parkinson's disease is caused by inactivity of dopamine-containing neurons in the brain. The signs and symptoms of the disease are the consequence of dysfunction and eventual death of dopamine neurons, which are involved in the regulation of motor activity and coordination. These symptoms include the characteristic rigidity, resting tremor and bradykinesia or difficulty in initiating movement.

GDNF protects dopamine neurons from toxic damage and restores functional activity to already damaged dopamine neurons. In preclinical models, GDNF has been shown to reverse the symptoms of Parkinson's disease. Because GDNF does not readily cross the blood-brain barrier following systemic administration, it will be administered directly into the brain. GDNF has been shown to access dopamine neurons via this route.

It is estimated that approximately 1 million Americans have been diagnosed with Parkinson's disease. Conventional treatment of Parkinson's disease primarily has consisted of dopamine agonists and replacement therapy in the form of L-dopa. Following the onset of symptoms, patients typically survive for 10-15 years, but the disease can be progressively debilitating after the first five years, and drugs which are efficacious early in the disease are less effective and have toxic side effects as the disease progresses

"We are pleased that the first human trial of this important potential therapeutic is now underway. Parkinson's disease is a common and tragic affliction and one for which current therapies have significant drawbacks. We hope that GDNF will provide patients and health-care providers with a more effective treatment option," said Gordon Binder, chairman and chief executive officer.

"At the start of the year, we said we would begin initial human clinical trials of five new product candidates during 1996; GDNF is the fifth of these potential products to advance to the clinic," Binder added.

Amgen is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advanced cellular and molecular biology.

CONTACT: Amgen, Thousand Oaks

David Kaye, 805/447-6692 (media)

Denise Powell, 805/447-4346 (investors)