Akesis Pharmaceuticals Enters Pact With Profil Institute for Clinical Research, Inc. To Launch Clinical Trials In Type 2 Diabetes
SAN DIEGO, May 4 /PRNewswire-FirstCall/ -- Akesis Pharmaceuticals, Inc. today announced that it has entered into a consulting agreement with Profil Institute for Clinical Research, Inc. under which the parties will develop a clinical research protocol and conduct other activities to support the initiation of new clinical trials in type 2 diabetes.
Akesis is developing a set of proprietary product formulations designed to lower and control blood glucose levels in patients with type 2 diabetes. The company has conducted an open-label initial clinical trial using one of these formulations, which demonstrated an average two-point decline in glycated hemoglobin levels (HbA1c), compared to base line, after three months of treatment in a diabetic population.
A double-blind, placebo controlled clinical trial in type 2 diabetic patients under development by Akesis and Profil is being designed with a goal of confirming and extending the results of the initial study.
Profil specializes in the design and management of clinical studies for new therapies in diabetes and other metabolic disorders. Profil also maintains an extensive patient recruitment database to facilitate identification of study participants.
"We are excited about working with Profil to advance our product portfolio," said Akesis Board member Kevin J. Kinsella. "This agreement provides Akesis with significant talent and resources in support of our development objectives."
About Akesis:
Akesis is a pharmaceutical company with a portfolio of innovative prospective treatment formulations for diabetes and other related metabolic disorders. The company possesses issued U.S. patents for both prescription and over-the-counter treatments, which uniquely combine anti-diabetic trace minerals with certain classes of diabetes oral agents. Akesis' products have demonstrated utility in lowering and controlling blood glucose levels in patients with type 2 diabetes. Blood sugar control via oral drugs represents a multi billion-dollar industry in the United States.
About Profil:
Profil Institute for Clinical Research, Inc. is a privately held company dedicated to the study and development of new therapeutics and devices that are intended to serve the diabetic community. Profil uses its expertise to guide the developmental planning and actual performance of clinical studies that help in the determination of whether a new compound should be carried forward into the later phases of clinical development. In order to make reliable and solid development decisions based on the most accurate data, Profil utilizes specific research methods, including the automated glucose clamp procedure, which is accepted as the gold standard for pharmacodynamic data. This methodology is available in only a handful of academic centers and Institutes worldwide. This procedure is used to determine the time-action profile of new blood glucose-lowering compounds and to evaluate their impact on insulin sensitivity and compartment specific glucose turnover.
Profil was founded in 1999 by a team of physicians and scientists who had been performing clinical trials at the World Health Organization (WHO) Collaborating center for Diabetes at Heinrich-Heine University of Dusseldorf, Germany. Profile now has facilities in Neuss, Germany and Chula Vista, California. The Institute has played a role in the development of diabetic therapies, including inhaled insulin, and as well as devices, for all major global pharmaceutical companies and numerous bio-pharmaceutical and device organizations.
Note regarding forward-looking statements:
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Akesis Pharmaceuticals disclaims any intent or obligation to update these forward- looking statements, and claims the protection of the Safe Harbor for forward- looking statements contained in the Act. Examples of such statements include, but are not limited to, any plans to develop a clinical research protocol and plans to conduct trial-support activities, the development of product formulations, any plans to initiate clinical trials, the maintenance of a patient recruitment database, and conclusions about the results of the contract. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the inability to raise additional capital, an amount of which is required to support completion of new clinical trials, difficulties or delays in development, testing, regulatory approval, production and marketing of the company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the company's drug candidates that could slow or prevent clinical development, product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials). For additional information about risks and uncertainties Akesis faces, see documents Akesis files with the Securities and Exchange Commission, including the report on Form 10-K for the fiscal year ended December 31, 2005, and all our quarterly and other periodic SEC filings. Akesis has not yet submitted any formulations to the Food and Drug Administration for review. The FDA has not made any determinations with regard to Akesis' proposed formulations. Akesis does not, at this time, manufacture, or offer products for sale.
Akesis Pharmaceuticals, Inc.CONTACT: Bob Giargiari, GPR GLOBAL for Akesis Pharmaceuticals,+1-619-884-4410; or Dr. Marcus Hompesch, CEO of Profil Institute forClinical Research, +1-619-409-1241
Web site: http://www.akesis.com//