Regeneron's Obesity Drug Demonstrates Medically Significant Weight Loss in Phase II Clinical Trial; Phase III Study Planned for 2001

"Everyone at Regeneron is pleased with these results, which indicate that AXOKINE has the potential to help address a growing health crisis. Millions of people in the United States suffer from obesity, and the problem is especially serious for the approximately 12 million people with clinically...

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Bibliographic Details
Published inBusiness Wire p. 1
Main Author Business Editors, Health/Medical Writers
Format Newsletter
LanguageEnglish
Published New York Business Wire 28.11.2000
Subjects
Amyotrophic lateral sclerosis
Cardiovascular disease
Clinical trials
Diabetes
Drug dosages
Drug withdrawal
Hypertension
Hypothalamus
Obesity
Patients
Value analysis
Weight control
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Summary:"Everyone at Regeneron is pleased with these results, which indicate that AXOKINE has the potential to help address a growing health crisis. Millions of people in the United States suffer from obesity, and the problem is especially serious for the approximately 12 million people with clinically severe obesity. The prevalence and severity of obesity has risen sharply in recent years in many developed nations, and that trend shows no signs of easing," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Subject to discussions with regulatory authorities, we plan on initiating Phase III testing of AXOKINE as quickly as possible to gather information about the safety and efficacy of the drug in larger numbers of patients over longer periods of time." AXOKINE is a genetically re-engineered version of a naturally occurring human protein known as ciliary neurotrophic factor (CNTF). Preclinical studies have shown that injected AXOKINE travels through the bloodstream to reach a critical area of the brain, known as the hypothalamus, that regulates body weight. Axokine binds to specific receptors and activates key signaling pathways in the hypothalamus that suppress appetite and reduce body weight. Both the site and mechanism of action of AXOKINE are similar to those of leptin, a natural hormone regulator of body weight that is released by fat cells. However, in animal models of the most common form of obesity (diet-induced obesity), animals are resistant to administration of leptin, while AXOKINE is able to cause substantial weight loss. CNTF was first recognized for its beneficial effects on motor neurons, and initially it was evaluated in patients suffering from a motor neuron disease known as amyotrophic lateral sclerosis (ALS). In a trial in over 750 patients suffering from ALS, CNTF caused significant weight loss. Using animal models of diet-induced obesity, Regeneron scientists deciphered the mechanism by which CNTF induced weight loss and identified doses of CNTF that caused weight loss without other side effects, such as cachexia or wasting. They then synthesized a new more potent version of CNTF, termed AXOKINE, from which certain immunogenic regions of the molecule were removed.