Axokine Diet Drug for the Treatment of
Obesity
Regeneron Pharmaceuticals (Nasdaq:REGN)
announced today that it will move forward with the Phase III development
program of Axokine for the treatment of obesity. This decision was made
following a meeting with the U.S. Food and Drug Administration (FDA) to
review results from the initial pivotal diet drug trial completed earlier
this year and the Company's plans for future development of Axokine as
an aid to weight loss.
More Diet Drug Trials
The remaining Phase III program is expected to consist of a one-year confirmatory
pivotal trial similar to the initial trial, a separate one-year study
in obese type 2 diabetic patients, and several smaller and shorter studies.
The trials will continue to enroll a broad range of overweight and obese
individuals. In total, approximately 2,300 additional people are expected
to be enrolled in future trials.
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Axokine Weight Loss
Drug Trial
Axokine has the potential to be a new weapon in the battle against
obesity. Though it causes moderate weight loss in most patients, a
significant proportion of patients exhibit substantial weight loss
with Axokine treatment. In the completed pivotal trial, almost three
times as many patients treated with Axokine plus a weight control
program lost over 10 percent of their body weight over twelve months
of treatment compared to those on a weight control program alone (11.3
percent versus 4.2 percent), and these patients averaged more than
30 pounds of weight loss." |
About Axokine Diet & Weight Loss
Drug
Axokine is a modified form of ciliary neurotrophic factor (CNTF), which
is in Phase III clinical development by Regeneron Pharmaceuticals for
the treatment of obesity. This investigational compound has a novel mechanism
of action - the inhibition of hunger signals that stimulate appetite.
Ongoing Phase III trials are studying the safety and efficacy of Axokine.
Source: Press Release, Sept. 9, 2003
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