>>SALT LAKE CITY, March 6 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today presented data from a clinical study in patients with type II diabetes that evaluated a capsule preparation of insulin using its eligen(TM) oral drug delivery technology. The data was presented at 10:30am (MT) at the Winter Symposium and 11th International Symposium on Recent Advances in Drug Delivery Systems, taking place in Salt Lake City, Utah, March 3-6, 2003. The presentation, made by Michael M. Goldberg, M.D., Chairman and Chief Executive of Emisphere, was entitled, "Oral Macromolecule Delivery: Reviews of the Large and Expanding Clinical Database."
The placebo controlled, crossover study evaluated two oral doses of insulin. Each capsule contained 5 mg of insulin and 200 mg of EMISPHERE® delivery agent, so each patient was evaluated with both a 5mg and 10 mg dose. The study compared the two oral unformulated dosages to a fast-acting injectable insulin in fourteen patients with type II diabetes who had received a standardized meal (standardized solid meal of 722 kcal). The study also included a placebo group. The data demonstrated for the 10 mg dose that oral insulin unformulated dosages, when administered 30 minutes prior to the standardized meal, reduced post-prandial glucose excursion (the rise in blood sugar following a meal), produced a marked increase in systemic insulin levels and a concomitant reduction in C-peptide (a marker of endogenous insulin production) as compared to the placebo. In addition, plasma insulin concentrations peaked faster using Emisphere's oral unformulated dosage as compared to fast acting injectable insulin (30 minutes for oral versus approximately 45 minutes for injectable formulations). Similar results were observed in certain patients given the 5 mg dose, who received the same standardized meal.
The data presented were part of a broader presentation on clinical results with the eligen(TM) technology. Dr. Goldberg also disclosed at the conference data related to other macromolecules (e.g. heparin, salmon calcitonin, and cromolyn) where Emisphere has made recent progress, and stated that Emisphere intends to submit the full data from the above referenced study for presentation at a diabetes meeting.
Dr. Goldberg, commented, "We are especially excited about the oral insulin data because in this study there was evidence that one or two capsules could impact post-prandial blood glucose in certain type II diabetic patients and that favorable pharmacokinetics continued to be demonstrated. This meaningful delivery of insulin using our eligen(TM) technology reinforces our belief in the potential for a more physiologic approach to deliver insulin. We have an active formulation program in place and continue to work on a final image dosage tablet formulation."
About Type II Diabetes and Insulin
The American Diabetes Association (ADA) estimates that 90-95% of the 17 million Americans with diabetes have Type II diabetes. This population is growing rapidly due to rising levels of obesity. The ADA recommends that patients with Type II diabetes taking insulin should time their insulin dose so that it begins working as glucose from meals enters the bloodstream (30 minutes before mealtime for regular insulin injections). Currently, insulin therapy is only available in injectable form.
About The eligen(TM) technology
Emisphere's broad-based oral drug delivery technology platform, known as the eligen(TM) technology, is based on the use of proprietary, synthetic chemical compounds, known as EMISPHERE® delivery agents, or "carriers". These molecules facilitate the transport of the therapeutic macromolecules across biological membranes such as the small intestine. Emisphere's eligen (TM) technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity.<<
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