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

To: keokalani'nui who wrote (213)	5/8/2003 2:00:15 PM
From: keokalani'nui	Read Replies (1) \| Respond to of 272

Emisphere Initiates U.S. Clinical Studies for an Oral Insulin Candidate Thursday May 8, 8:09 am ET TARRYTOWN, N.Y., and NEW ORLEANS, May 8 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) announced today that it is initiating clinical testing of an oral insulin formulation in type 2 diabetic patients in the United States under an Investigational New Drug (IND) application filed with the United States Food and Drug Administration (FDA). The formulation uses Emisphere's eligen(TM) oral drug delivery technology to deliver the insulin in a capsule. This is the first oral insulin clinical study in the United States using Emisphere's technology. ADVERTISEMENT The Phase I study is a single-blind, open-label cross-over study designed to assess the safety, tolerability and pharmacokinetics of Emisphere's oral insulin formulation with an EMISPHERE® delivery agent in twelve type 2 diabetic patients. During the treatment phase, the oral insulin capsules will be administered after an overnight fast. Each subject will receive one of three treatments consisting of escalating doses of insulin and an EMISPHERE® delivery agent, or a treatment of EMISPHERE® delivery agent alone. The study will be conducted at Clinical Research Center in New Orleans, Louisiana. Richard E. Connor, Senior Director, Quality and Regulatory Affairs, stated, "The initiation of our oral insulin development program in the U.S. is another Emisphere development milestone and a solid indication of progress with our eligen(TM) oral drug delivery technology. We believe this study will add to the clinical data we have previously generated in healthy volunteers, type 1 and type 2 diabetic patients. We also believe this study will broaden our understanding of the formulation of our delivery agent with insulin, enhancing the value of our oral insulin product candidate for potential partnering." Emisphere's development efforts are focused on further optimizing the formulation of its oral insulin product candidate. Previous studies with an unformulated oral insulin capsule showed peak plasma insulin concentrations within 20-25 minutes. This was significant in that it was an improvement in rate over the leading rapid-acting injectable insulin product. A rapid and consistent rate of absorption of a meal-time insulin could allow oral insulin to be administered closer to a meal, which is an important feature for increasing patient compliance. Robert A. Gelfand, M.D., Associate Clinical Professor, Yale University School of Medicine, and member of Emisphere's Scientific Advisory Board, stated, "The initiation of this study under an IND in type 2 diabetic patients using Emisphere's eligen(TM) oral drug delivery technology is very encouraging. Prior studies in healthy and diabetic subjects have shown insulin absorption from the gastrointestinal tract with a rapid onset of action and a dose-dependent decrease in blood sugar levels appropriate for serum insulin levels. If an oral insulin can be developed successfully, it will provide a very attractive new treatment option that could even be used early in type 2 diabetes as a first line therapy."