>>TARRYTOWN, N.Y.--(BW HealthWire)--April 9, 2002-- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - news) today announced the initiation of two additional studies within the Phase III clinical program of AXOKINE® for the treatment of obesity.
The trials are designed to study long-term maintenance of weight loss following shorter-term treatment regimens.
The randomized, double blind studies will assess the safety and efficacy of AXOKINE compared with placebo in two different dosing periods. Participants in the first study will be given AXOKINE or placebo for 6 months and will then be observed for another 6 months off-treatment. The companion study will treat subjects with AXOKINE or placebo for 3 months and observe them for an additional 9 months off-treatment. The trials will run concurrently. At the end of the initial 12-month treatment and observation period of the two studies, participants will again receive AXOKINE or placebo for a brief re-treatment period. In total, each study will run 18 months from enrollment to completion. The primary end-point of these studies is weight loss at the end of 12 months.
Dr. Louis Aronne, Clinical Associate Professor of Medicine at Cornell University Medical College, a weight control expert and an AXOKINE clinical trial investigator, said, ``Obesity is increasingly recognized as a significant global medical problem that requires new treatment options. I'm pleased by the progress of this unique new product candidate for obesity as it moves through the rigorous safety testing that is required in these trials for approval by the Food and Drug Administration.''
Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron, said, ``We are pleased to announce the initiation of these studies, consistent with the plan we announced last summer. In these new trials, we want to examine shorter term regimens which may be appropriate for patients who can reach their weight loss objectives over shorter time periods with our investigational candidate. These studies are designed to explore results we observed in Phase II, which showed that subjects taking AXOKINE for 3 months were able, on average, to maintain their weight loss during a 36-week evaluation period after treatment ended.''
Each study will involve approximately 300 subjects. The trials will be conducted at approximately 20 study sites within the U.S. Study participants will be overweight and obese individuals with a body mass index (BMI) of 27 to 50 kg/m2 (kilograms per meter of height squared).<<
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