Akesis Pharmaceuticals Engages Quintiles and Dgd Research for Clinical Services
Akesis Pharmaceuticals, Inc. (OTCBB:AKES), an emerging diabetes drug-development company, today announced it has engaged Quintiles Transnational Corp and dgd Research to provide analytical and clinical services related to the Company’s lead product candidate, AKP-020, otherwise known as bis(ethylmaltolato)oxovanadium (IV), or BEOV. Pending FDA review and approval, Quintiles will be responsible for overall project supervision and data management for upcoming trials, while dgd Research will be conducting the planned Phase Ib human clinical trials in its San Antonio facility.
“We are looking forward to beginning clinical research with BEOV later this year following the FDA’s review of our plans,” said Jay Lichter, Ph.D., president and chief executive officer of Akesis Pharmaceuticals. “Quintiles and dgd Research have considerable experience in managing and conducting the type of trials we have proposed to advance the development of AKP-020.”
AKP-020 is a novel vanadium compound that has shown considerable potential as a treatment for patients with Type 2 diabetes. Data from a Phase I trial evaluating BEOV in healthy volunteers provided the clinical evidence of reasonable safety to support additional FDA-approved studies. Phase I data showed the compound has advantages over unpatented vanadyl sulfate with respect to dosing, pharmacokinetics and bioavailability, without any apparent signs of toxicity.
About Quintiles
Quintiles Transnational Corp. is powering the next generation of healthcare by providing a broad range of professional services in drug development, financial partnering and commercialization for the pharmaceutical, biotechnology and healthcare industries. With 18,000 employees and offices in more than 50 countries, it is focused on providing customer-centric solutions that are the gold standard of the industry. For more information, please visit www.quintiles.com.
About dgd Research
dgd Research is a world leader in providing relevant patient populations to meet or exceed clients’ study requirements while making a positive impact on the welfare and education of study participants. Formerly known as the Diabetes & Glandular Disease Research Associates, dgd Research also develops and delivers high-quality systems and services to support clinical decisions and outcomes, performing more than 1,500 Phase I-IV clinical trials in diabetes, hypertension, neuropathy, osteoporosis, cholesterol, obesity, menopause, and nephropathy under the supervision of major pharmaceutical companies in accordance with FDA rules and regulations. dgd Research currently leads the U.S. market in Phase I endocrine/metabolic clinical trials and is fifth nationwide for Phase II-IV trials. For more information, please visit www.dgdresearch.com.
About Akesis
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 development of Akesis’ product candidates, including AKP-020, and Akesis’ ability to conduct additional FDA-approved studies relating to its product candidates, including 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.