FDA Accepts Akesis Pharmaceuticals' AKP-020 IND Application For A Phase IIa Study In The Treatment Of Type 2 Diabetes

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 12 Nov 2007 - 11:00 PDT

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Akesis Pharmaceuticals, Inc. (OTCBB:AKES), an emerging diabetes drug-development company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AKP-020, a novel vanadium compound, to test its safety and efficacy in patients with Type 2 Diabetes.

dgd Research, Inc. of San Antonio has begun screening patients in a Phase IIa, controlled U.S. clinical trial measuring efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping procedure), as well as pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetic patients.

"We are extremely pleased to have received clearance and guidance from the FDA to begin our clinical study with AKP-020," said Jay Lichter, president and chief executive officer of Akesis. "Our development program is on schedule, and we expect to dose our first patient before the end of 2007."

AKP-020 is the product designation for a novel vanadium compound otherwise known as bis(ethylmaltolato)oxovanadium (IV), or BEOV. The compound was invented and developed by University of British Columbia researchers Chris Orvig, professor of chemistry and pharmaceutical sciences, and John McNeill, Ph.D., professor and dean emeritus, pharmaceutical sciences, and is licensed exclusively to Akesis Pharmaceuticals. Professors Orvig and McNeill, who are experts in the study of metal chemistry and pharmaceutical sciences, helped to advance the BEOV program through Phase I clinical trials. They also are members of the Akesis Scientific Advisory Board.

About Akesis Pharmaceuticals

Akesis Pharmaceuticals has a pipeline of innovative oral product candidates for the treatment of diabetes and related metabolic disorders. These product candidates are supported by issued and filed U.S. patents for both prescription and over-the-counter treatments that combine anti-diabetic trace minerals with certain classes of diabetes oral agents. Akesis' product candidates have demonstrated preliminary evidence of efficacy in lowering and controlling blood glucose levels in patients with Type 2 diabetes. Blood sugar control via oral drugs represents a market opportunity in the billions of dollars, as reports indicate that approximately 20 million people suffer from diabetes in the United States alone. More information can be found at http://www.akesis.com.

Forward-Looking Statements

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can generally be identified as such because the context of the statement will include words such as "will", "expects", "should", "believes", "anticipates" or words or phrases of similar meaning. Examples of such statements include statements relating to Akesis' Phase IIa trial relating to AKP-020 and its clinical development program as a whole. Stockholders, potential investors and other readers are cautioned that these forward-looking statements are predictions based only on current information and expectations that are inherently subject to risks and uncertainties that could cause future events or results to differ materially from those set forth or implied by the forward-looking statements. Certain of those risks and uncertainties are discussed in Akesis' filings with the Securities and Exchange Commission, including Akesis' most recent annual report on Form 10-K (as amended by its annual report on Form 10-K/A) and quarterly reports on Form 10-QSB. These forward-looking statements are only made as of the date of this press release, and Akesis does not undertake any obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Akesis Pharmaceuticals

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