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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Scott H. Davis who wrote (557)	7/31/2001 8:52:19 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 3557

It will be a long 12 and 24 months, but I have no reason to believe that it will not pay at end. Miljenko Press Release Regeneron Initiates Phase III Clinical Program of AXOKINE for Treatment of Obesity TARRYTOWN, N.Y.--(BW HealthWire)--July 31, 2001--Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN - news) announced that it has initiated a Phase III clinical program of AXOKINE® for the treatment of obesity. The program will assess the safety and efficacy of AXOKINE for weight loss in overweight and obese patients. The initial pivotal trial will enroll approximately 2,000 patients at over 60 study sites across the United States in a double-blind, randomized, placebo-controlled study. This trial will have a 12-month treatment period, in which patients will receive daily subcutaneous self-injections of placebo or AXOKINE at a dose of 1.0 microgram (mcg) per kilogram (kg) of body weight. The treatment period will be followed by a 12-month open-label safety extension phase, during which all patients will receive AXOKINE. Endpoints of the study are based on changes in body weight versus baseline during the treatment period. To be included in the initial study, patients must not be diabetic and must have a body mass index (BMI) of 30 to 55 if they do not have obesity-related risk factors and 27 to 55 if they have obesity-related risk factors, such as elevated blood pressure or increased blood lipids. People are classified as overweight if they have a BMI between 25 and 30, and obese if they have a BMI of 30 or greater. BMI is a medical measure of obesity. It measures weight in relation to height and is calculated as weight in kilograms divided by height measured in meters, squared. For example, a person 5'8`` tall weighing 174 pounds would have a BMI of 27 and be considered overweight. The same 5'8'' adult weighing 258 pounds would have a BMI of 40 and be considered extremely obese. <snip> Tuesday July 31, 4:05 pm Eastern Time Press Release Regeneron Updates Results of Obesity Trial for AXOKINE-R- Patients Maintain Average Weight Loss 24 Weeks Following 12 Weeks of Treatment TARRYTOWN, N.Y.--(BW HealthWire)--July 31, 2001-- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN - news) released follow-up data from its Phase II study of AXOKINE for obesity, reporting that, on average, patients treated with AXOKINE maintained their weight loss for 24 weeks following a 12-week treatment period. In contrast, patients receiving placebo not only failed, on average, to lose weight during the treatment phase, but they also gained weight in the 24 weeks following cessation of placebo. The initial 12-week treatment phase was conducted in a double-blind and placebo-controlled manner, and the patients remain blinded during the non-treatment follow-up period. The 24-week follow-up results released today extend similar 12-week follow-up data reported by the Company earlier this year, as well as published studies by Regeneron scientists showing that AXOKINE can cause weight loss in animals without rebound weight gain following treatment cessation. As previously reported, during the treatment phase of Regeneron's Phase II clinical trial of AXOKINE, severely obese patients demonstrated medically meaningful and statistically significant weight loss in a dose-dependent manner compared with placebo. In this trial, patients who received the optimal dose of AXOKINE, 1.0 microgram (mcg) per kilogram (kg) of body weight, averaged about 10 pounds more weight loss than patients on placebo over the 12-week treatment period. Regeneron now reports the results at 24 weeks following treatment cessation. At the end of this follow-up period, patients treated with the optimal 1.0 mcg/kg dose of AXOKINE lost, on average, 12.4 pounds relative to their baseline weight, compared with placebo treated patients who gained 4.0 pounds, for a total differential versus placebo of 16.4 pounds. Combining all dose groups treated with AXOKINE for 12 weeks yields 7.8 pounds of weight loss relative to baseline weight, for a total differential versus placebo of 11.8 pounds. These results are based on preliminary analysis of interim data. Results for all patients who received AXOKINE or placebo during the 12-week treatment period and the subsequent follow-up periods are summarized below: Mean Change from Baseline Weight (Pounds) Total Available Data for All Patients AXOKINE Placebo 0.3 mcg/kg 1.0 mcg/kg 2.0 mcg/kg Combined AXOKINE 12 Weeks + 0.2 -3.5 -9.1 -8.0 -6.9 (end of blinded treatment) (n=23) (n=23) (n=26) (n=19) (n=68) 18 Weeks + 2.2 -4.7 -9.6 -7.8 -7.5 (6 weeks off treatment) (n=19) (n=22) (n=25) (n=18) (n=65) 24 weeks + 1.9 -4.8 -9.9 -5.8 -7.1 (12 weeks off treatment) (n=19) (n=18) (n=23) (n=17) (n=58) 36 weeks +4.0 -4.4 -12.4 -5.4 -7.8 (24 weeks off treatment) (n=15) (n=18) (n=19) (n=12) (n=49) Results for just those patients who completed the full 36 weeks in the study are: Mean Change from Baseline Weight (Pounds) Data for Patients Who Completed 36 Weeks Follow Up AXOKINE Combined Placebo 0.3 mcg/kg 1.0 mcg/kg 2.0 mcg/kg AXOKINE n = 15 n = 18 n = 19 n = 12 n = 49 12 Weeks (end of blinded treatment) + 0.1 -4.7 -9.4 -8.5 -7.4 18 Weeks (6 weeks off treatment) + 2.6 -5.4 -9.6 -9.0 -7.9 24 Weeks (12 weeks off treatment) + 2.9 -4.8 -9.7 -7.9 -7.5 36 Weeks (24 weeks off treatment) + 4.0 -4.4 -12.4 -5.4 -7.8 ``While we must continue to study AXOKINE in larger patient populations over longer periods of time, we are excited by these results, which reinforce our belief in the potential benefits of AXOKINE,'' noted Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. ``Obesity is a complex chronic disease that contributes to about 300,000 premature deaths each year in this country. Patients need effective new therapies, especially ones that may hold the promise of allowing weight loss without the rebound weight gain that typically follows weight loss programs and treatments.'' <snip>