>>TARRYTOWN, N.Y.--(BW HealthWire)--June 13, 2002--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) announced that it has initiated a Phase I clinical trial to assess the safety and pharmacokinetics of the Company's pegylated version of AXOKINE® (PegAXOKINE) for the treatment of obesity.
Regeneron developed this chemically modified version of AXOKINE as a potentially more potent and longer-lasting molecule. AXOKINE is currently being evaluated in a large Phase III program for overweight and obese patients. The PegAXOKINE Phase I trial is a placebo-controlled, double-blind, single-dose, dose-escalation study.
"The PegAXOKINE clinical trial represents another important milestone in our efforts to develop a therapeutic to combat the escalating obesity epidemic," noted Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "The pegylated version of AXOKINE gives us another potential treatment path for a condition that scientists, governments, and key thought leaders have identified as one of the most rapidly growing medical problems facing the developed world today. Our Phase III pivotal trial for the original form of AXOKINE is half way through the 12-month efficacy phase. We have initiated three additional studies for AXOKINE and plan others for later this year. The PegAXOKINE study allows us to explore lower dosing regimens and less frequent dosing. We believe that AXOKINE and PegAXOKINE may prove to be important therapeutic solutions for the healthcare problems caused by or exacerbated by obesity."
PegAXOKINE: Modified Version of AXOKINE
Pegylated AXOKINE is a second-generation molecule designed to remain in the bloodstream longer. Pegylation achieves that goal by attaching polyethylene glycol polymer chains to therapeutic molecules. Shearwater Corporation, a division of Inhale Therapeutics Systems, Inc., will supply the pegylated reagent that, with other chemical modifications to AXOKINE, results in a potentially more potent and longer acting therapeutic candidate, called PegAXOKINE. AXOKINE is a protein that is taken daily by a self-administered sub-cutaneous injection. Regeneron will evaluate alternative dosing regimens with PegAXOKINE to take advantage of the potentially extended time in which this modified molecule circulates in the bloodstream.<<
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>>TARRYTOWN, N.Y.--(BW HealthWire)--June 13, 2002--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN - News) today announced the initiation of a clinical trial to assess the safety and efficacy of AXOKINE® in overweight and obese individuals with type 2 diabetes mellitus.
This is the fourth clinical trial to be initiated as part of Regeneron's Phase III clinical program of AXOKINE for the treatment of obesity. This is the first of two planned studies that will measure the weight loss effects of AXOKINE in people who have type 2 diabetes mellitus.
"More than 15 million people in the United States suffer from diabetes, and each year another 800,000 Americans are newly diagnosed. The medical costs of treating diabetes exceed $45 billion annually," noted Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Excess weight has been linked to type 2 diabetes and is associated with many of its chronic side effects. With this trial, we want to begin evaluating weight loss with AXOKINE in people who have type 2 diabetes to see if it may reduce some of the negative effects of this growing healthcare problem."
Summary of Clinical Study in Patients with Type 2 Diabetes Mellitus
This AXOKINE study is double-blind and placebo-controlled. Participants will be randomized into three treatment groups and given placebo or one of two AXOKINE doses (0.5 or 1.0 mcg/kg/day) for 12 weeks. At the end of the initial phase, all participants, in two separate dose groups, will receive AXOKINE for a 12-week extension period. This trial will measure weight loss and explore the short-term effects of weight loss with AXOKINE on blood levels of insulin, glucose, and other glycemic parameters.
The study will involve approximately 180 overweight and obese subjects with type 2 diabetes. The study will be conducted at approximately 12 sites within the United States. Study participants will be adults who have a body mass index (BMI) of 27 to 45 kg/m2 (kilograms per meter of height squared).
Type 2 Diabetes Mellitus
Type 2 diabetes is a chronic disease associated with insulin deficiency and insulin resistance. The US Department of Health and Human Services estimates that more than 90 percent of people with diabetes have type 2 diabetes, which is a risk factor for heart disease.
The number of people who develop type 2 diabetes has been rising rapidly, and obesity has been associated with this condition. Weight gain leads to pathological changes of metabolism described as "metabolic syndrome". This syndrome includes elevated lipids, abnormal handling of glucose, and resistance to insulin. These abnormal, pre-diabetic, changes are believed to be reversible if an obese person loses weight. In a later stage, overt diabetes with elevated blood glucose levels ensues. The study protocol includes numerous metabolic assessments, and the analysis of the trial will relate AXOKINE-induced weight loss to changes in metabolic parameters.<<
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