July 10, 2007 Akesis Pharmaceuticals Files Pre-IND for AKP-020 SAN DIEGO--(BUSINESS WIRE)--Akesis Pharmaceuticals, Inc. (OTCBB:AKES - News), an emerging diabetes drug-development company, today announced the filing of a preliminary Investigational New Drug (pre-IND) application with the U.S. Food and Drug Administration (FDA) for its lead product candidate AKP-020. The purpose of the pre-IND is to obtain a meeting with FDA officials, which typically occurs 60 days after submitting the application, to review data supporting an IND application and to discuss proposed trial protocol. Once Akesis has an IND approved by the FDA, the Company intends to initiate a Phase Ib/IIa trial to assess the safety and efficacy, and determine the pharmacokinetics of AKP-020 in patients with Type 2 diabetes. "We believe AKP-020 possesses all the necessary attributes to progress into human clinical testing, and offers significantly improved pharmacological properties over other vanadium-based compounds," said Jay Lichter, Ph.D., president and chief executive officer of Akesis Pharmaceuticals. 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. Currently Akesis is partnering with Charles River Laboratories in conducting a non-clinical, renal-focused animal 28-day safety and toxicology study for AKP-020 (BEOV). 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 Akesis' ability to secure critical FDA approvals of its proposed studies and the initiation of a Phase Ib/IIa trial 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-K (as amended by its annual report on Form 10-K/A) 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. Contact: Akesis Pharmaceuticals, Inc. Jay Lichter, Ph.D., President & CEO, 858-454-4311 jlichter@akesis.com Lippert/Heilshorn & Associates Don Markley or Eleanor Tang, 310-691-7100 dmarkley@lhai.com etang@lhai.com News Main Menu