some old stuff, this is the closest I found relating to clinical trial. Nostalgic, isn't it?
Amgen-Regeneron Partners To Progress To
Phase III Trials Of BDNF In Lou Gehrig's Disease
THOUSAND OAKS, Calif., June 26, 1995 -- Amgen and Regeneron
Pharmaceuticals, Inc. today announced that a Phase III clinical trial of
Brain-Derived Neurotrophic Factor (BDNF) will be initiated during the third
quarter of 1995. This decision to move forward with a pivotal trial in a
larger patient population is based on preliminary analysis of Phase I/II
clinical trial data involving 283 patients showing that BDNF appears to be
safe and well tolerated in treating people with amyotrophic lateral
sclerosis (ALS), commonly known as Lou Gehrig's Disease. The Phase III trial
is designed to confirm an effective treatment regimen.
Within the apparent therapeutic dose range, patients receiving BDNF
appear to have about half the deterioration of breathing capacity in
comparison to the patients on placebo. This result was statistically
significant. Breathing capacity was measured by forced vital capacity
(FVC), a reliable measure of respiratory function and an established clinical
indicator in this neurodegenerative disorder. Loss of breathing capacity is
the major cause of death from ALS. In addition, a trend toward
improvement in survival among treated patients was observed, however
this improvement has not reached the level of statistical significance.
There was no discernible effect of BDNF on bulbar function or isometric
muscle strength.
The trial investigators reviewed the results of the Phase I/II trials during
the past few days and plan to present data about the trials at a scientific
conference during the second half of this year.
"The results of this trial with BDNF suggest that a drug can slow the loss of
breathing capacity that is so devastating to patients with ALS," said
Leonard S. Schleifer, M.D., Ph.D., president and chief executive officer of
Regeneron.
"We are encouraged by these promising Phase I/II results and now hope
that they will be confirmed in a large, Phase III study," said Gordon Binder,
Amgen's chairman and chief executive officer.
ALS is a neurodegenerative disorder affecting the nerve cells which
control muscle function. The disease causes progressive weakness and,
eventually, paralysis. Weakness and paralysis of the chest muscles and
diaphragm caused by ALS lead to progressive respiratory insufficiency and,
in most cases, death within three to five years from the first appearance of
symptoms.
Amgen (NASDAQ: AMGN) is a global biotechnology company that discovers,
develops, manufactures and markets human therapeutics based on
advanced cellular and molecular biology.
Regeneron (NASDAQ: REGN), based in Tarrytown, N.Y., is a leader in the
discovery and development of biotechnology-based compounds for the
treatment of neurodegenerative diseases, peripheral neuropathies and
nerve injuries.
Amgen-Regeneron Partners is an equal partnership established in 1990 as
part of a collaborative research and development agreement between the
two companies. A Phase I trial of another neurotrophic factor, NT-3, is
being conducted by Amgen in peripheral neuropathies on behalf of the
partnership. Regeneron and Amgen are also conducting preclinical
development of BDNF and NT-3 for treating other neurodegenerative
diseases and conditions.
EDITORS NOTE: For clinical trial enrollment information, health care
professionals and patients can contact Amgen at 1-800-772-6436 or the
ALS Association at 1-800-782-4747.
CONTACT: Amgen, Thousand Oaks
David Kaye, 805/447-6692 (media)
Denise Powell, 805/447-4346 (investors)
Regeneron
Murray Goldberg, 914/345-7741
Michael Gross, 212/484-7721 |
