RALEIGH, N.C., March 30, 2009 (GLOBE NEWSWIRE) -- Today DARA BioSciences, Inc. (Nasdaq:DARA) announced that two abstracts have been accepted for presentation at the annual American Diabetes Association ("ADA") Scientific Sessions to be held in New Orleans, LA, June 5-9, 2009. The presentations will provide details on the company's lead diabetes candidate DB959 which was cleared by the United States Food and Drug Administration ("FDA") for Phase 1 Clinical Studies, earlier this month.
The first abstract entitled "DB959, a Novel, Dual PPAR-delta/gamma Agonist with a Favorable Nonclinical Safety Profile" has been selected for a poster presentation in the session "Clinical Therapeutics/New Technology - Pharmacologic Treatment of Diabetes or its Complications" on June 6, 2009.
The second abstract entitled "DB959 is a Novel, Dual PPAR delta/gamma Agonist which Controls Glucose and Regulates Triglycerides and HDLc in Animal Models of T2D and Dyslipidemia" has been selected for an oral presentation in the session "New Treatments in Development" on June 8, 2009.
Mary Kay Delmedico, Ph.D., leader of the DB959 Program at DARA, said, "It is an honor to have the results of our work chosen by the ADA for presentation."
About DB959
Earlier this month, the United States Food and Drug Administration ("FDA") cleared the Company's Investigational New Drug Application ("IND") for DB959, allowing DARA to commence Phase 1 studies in humans. DB959 is a unique, first-in-class dual peroxisome proliferator activated receptor ("PPAR") delta/gamma agonist and is intended for use in the treatment of Type 2 Diabetes Mellitus (T2D) including addressing the abnormalities in cholesterol and triglycerides in these patients. The Company plans to develop DB959 as a once-a-day oral medication alone and in combination with other approved medicines. At the present time, DARA is in the process of evaluating strategies for raising additional capital and/or forming strategic partnerships to fund further clinical development.
The unique combination of the delta/gamma agonist activities gives this therapeutic candidate the potential to provide cardiovascular benefit to Type 2 diabetes patients. In non-clinical studies, DB959 demonstrated the potential to control blood sugar, raise good HDL cholesterol, lower triglycerides, lower total cholesterol and improve the HDL:LDL ratio. In addition, the IND-enabling non-clinical safety studies performed with DB959 suggest a more favorable safety profile than selective delta or gamma agonists or combination agonists with alpha activity, particularly with regard to cardiovascular safety. DB959 is a non-thiazolidinedione (non-TZD) and does not have PPAR-alpha activity and is unique from Avandia(r) and Actos(r) both in structure and activity.
About DARA BioSciences, Inc.
DARA BioSciences(tm), Inc. ("DARA") is a Raleigh, North Carolina based development-stage pharmaceutical company that acquires promising therapeutic small molecules and develops them through proof of concept in humans for subsequent sale or out-licensing to larger pharmaceutical companies. It has a portfolio of drug candidates for neuropathic pain, type 2 diabetes, and psoriasis. For more information please contact the Company at 919-872-5578 or visit our web site at www.darabio.com.
All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA's current cash position and its need to raise additional capital in the near term in order to be able to continue to fund its operations, risks and uncertainties relating to DARA's ability to develop and bring new products to market as anticipated, the current regulatory environment in which the company develops and sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property, the intellectual property of others, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission. Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.