|
A modified second generation
ciliary neurotrophic factor, known as AXOKINE, has potential
for the treatment of obesity, according to the results of
a phase II study reported by developer Regeneron.
The placebo-controlled, randomized trial enrolled 170 severely
or morbidly obese patients at centers in the USA who received
0.3, 1.0 or 2.0 mg/kg AXOKINE or placebo by daily subcutaneous
self-injection for 12 weeks.
Mean changes in weight from baseline of -3.4, -8.9, -7.5
or +1.3 pounds were seen at these doses, repsectively, by
completer analysis and -2.4, -7.5, -5.8 and +0.6 pounds
by last observed value analysis, in the groups receiving
drug for 12 wk.
Another group was treated with 1 mcg/kg for eight weeks
followed by a withdrawal period of four weeks. In this group,
the weight lost during treatment was not regained following
withdrawal of the therapy.
AXOKINE was well tolerated, the most common side effect
being injection site reactions. Other side effects associated
with AXOKINE were cough and nausea, which were both most
frequently reported at the highest doses. Neutralizing antibodies
occurred in around 17% of patients.
Regeneron plans to initiate phase III investigations during
2001.
|
