01:15 PM ET 01/10/97
Amgen /Regeneron BDNF trial fails
THOUSAND OAKS, Calif., Jan 10 (Reuter) - Amgen Inc
and Regeneron Pharmaceuticals Inc said the Phase III clinical
trial of Brain-Derived Neurotrophic Factor (BDNF) failed to
show clinical efficacy in patients with Lou Gehrig's disease.
"While the trial confirmed the safety and tolerability seen
in earlier trials, it showed no statistically significant or
clinically relevant difference in breathing capacity or
survival between treatment and placebo groups," the companies
said in a statement.
Lou Gehrig's Disease, also called amyotrophic lateral
sclerosis (ALS) is a degenerative disease that attacks the
nervous system and often renders patients unable to breathe. It
afflicts between 20,000 and 40,000 people in the U.S.
Amgen and Regeneron said they are continuing to study the
efficacy of BDNF in treating Lou Gehrig's Disease when it is
delivered intrathecally, or injected directly into the
patient's spinal fluid. The trials for which results were
announced Friday were based on subcutaneous, or regular,
injection.
The companies are also exploring BDNF as a treatment for
diabetic neuropathy, another nervous system disorder.
"We continue to believe that neurotrophic factors have
potential to benefit patients with neurological diseases,"
Leonard Schleifer, Regeneron president and chief executive
officer said in a statement. |
