June 4, 2008 Akesis Pharmaceuticals Completes Phase IIa Trial of AKP-020 for Type 2 Diabetes SAN DIEGO--(BUSINESS WIRE)-- Akesis Pharmaceuticals, Inc. (OTCBB:AKES), an emerging diabetes drug-development company, today announced that it has completed the recruitment and dosing phases in its placebo-controlled Phase IIa trial designed to test the safety and efficacy of AKP-020, a novel vanadium compound, in patients with Type 2 diabetes. In this single blinded study in Type 2 diabetic subjects Akesis dosed a total of 10 Type 2 diabetic patients with either 20mg of AKP-020 or placebo. While Akesis originally planned to recruit and dose 21 patients in this trial, the Company has elected to discontinue the trial prior to the original endpoint in favor of advancing to a larger, multi-center, double-blind, dose-ranging study. The results of the original 10-patient trial and the plans for the larger study will be submitted to the FDA for review. “We are encouraged by the initial findings of this Phase IIa trial and we look forward to studying the safety and potential treatment benefits of AKP-020 in additional diabetic patients in subsequent studies,” said Jay Lichter, president and chief executive officer of Akesis. The Phase IIa trial for AKP-020 in diabetic patients at a single site measured efficacy by assessing the activity of the drug using several parameters including changes in plasma glucose levels upon oral glucose challenge following treatment, and insulin sensitivity in the gold-standard euglycemic-hyperinsulinemic clamping procedure. The safety aspects, including the pharmacokinetic following a single oral dose, were also carefully assessed. 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. 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 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 the results from Akesis’ Phase IIa clinical trial of AKP-020 and the Company’s plans to initiate subsequent studies relating to AKP-020. 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-KSB and quarterly reports on Form 10-Q. 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. Contacts Akesis Pharmaceuticals, Inc. Jay Lichter, Ph.D., President & CEO, 858-454-4311 jlichter@akesis.com or Lippert/Heilshorn & Associates Don Markley, 310-691-7100 dmarkley@lhai.com Source: Akesis Pharmaceuticals, Inc. View this news release online at: http://www.businesswire.com/news/home/20080604005284/en ### News Main Menu