Regeneron Completes Enrollment of Phase III Studies for Short-Term Treatment Regimens With AXOKINE for Obesity
Studies Will Measure Shorter Dosing Periods and Subjects' Ability to Maintain Weight Loss Without Rapid Weight Gain Following Cessation of Treatment
TARRYTOWN, N.Y.--(BW HealthWire)--July 25, 2002-- Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN - News) announced today that it has completed enrollment for two additional studies within its Phase III clinical development program of AXOKINE® for the treatment of obesity. The trials are designed to study maintenance of weight loss following short-term treatment regimens with AXOKINE.
"Full enrollment of these studies marks another important milestone in the development of AXOKINE," said Hans-Peter Guler, M.D., Regeneron's Vice President, Clinical Sciences. "In our Phase II trial, subjects treated with AXOKINE for three months experienced, on average, statistically significant weight loss that was not followed by the rapid rebound weight gain often associated with weight loss programs. These new studies are designed to confirm these earlier results."
Commenting on the overall Phase III program, Dr. Guler said, "We have now enrolled more than 2,600 participants in four separate studies and plan to initiate additional specialized and confirmatory studies later this year. In our pivotal trial, which enrolled nearly 2,000 patients, the average time on study exceeds eight months. The final patient in the pivotal trial will complete 12 months of treatment early next year, and we expect to have weight loss data in the spring of 2003."
The Short-term Treatment Studies
The randomized, double-blind, short-term treatment studies will assess the safety and efficacy of AXOKINE compared with placebo in two different dosing periods. Participants in the first study are being given AXOKINE or placebo for 6 months and will then be observed for another 6 months off-treatment. The companion study is treating subjects with AXOKINE or placebo for 3 months and will observe them for an additional 9 months off-treatment. The primary end-point of these studies is weight loss at the end of 12 months.
The trials, running concurrently and each with about 300 subjects, are being conducted at approximately 20 study sites within the U.S. At the end of the initial 12-month treatment and observation periods of the two studies, participants will receive an additional 6 months of treatment of which 3 months is on AXOKINE and 3 months on placebo. A follow-up evaluation will be made to assess the safety and weight-loss effects of re-treatment with AXOKINE.
About Regeneron
Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic candidates in clinical trials for the potential treatment of obesity, rheumatoid arthritis, and cancer, and has preclinical programs in asthma, allergies, and other diseases and disorders. Regeneron's platform technologies include Targeted Genomics(TM), Functionomics(TM), and Designer Protein Therapeutics(TM). |
