SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Akesis Pharmaceuticals, Inc. today announced that it has completed manufacturing of several lots of its proprietary combination drug candidate AKP-101 through its manufacturing partner, Douglas Laboratories of Pittsburgh, PA, to support the initiation of new clinical trials in type 2 diabetes. Akesis is designing a double-blind placebo controlled trial to evaluate the effectiveness of AKP-101, in combination with metformin, in lowering and controlling blood glucose levels in type 2 diabetes patients.
Akesis holds numerous issued patents and patent applications relating to the use of chromium, vanadium and other components with metformin, sulfonylureas, and other classes of diabetic agents. In an open-label study, Akesis demonstrated significant reductions in glycated hemoglobin (HbA1c) levels in subjects with type 2 diabetes when administering one of its products in combination with metformin and sulfonylureas.
“This achievement represents an important step toward our goal of bringing to market improved therapies for individuals with type 2 diabetes,” said Akesis president and CEO Jay Lichter, Ph.D. “Our manufactured drug product was made under cGMP guidelines and is suitable for our upcoming trial.”
About Akesis:
Akesis is a pharmaceutical company with a portfolio of innovative prospective treatments 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.
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 initiate clinical trials or to otherwise seek to confirm the utility of the company’s products, and the suitability of these products for clinical trials. 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, and 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.
Contact: Bob Giargiari, GPR GLOBAL
619-884-4410
Akesis Pharmaceuticals, Inc.
CONTACT: Bob Giargiari of GPR GLOBAL, +1-619-884-4410, for AkesisPharmaceuticals, Inc.
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