RALEIGH, N.C., March 10, 2009 (GLOBE NEWSWIRE) -- DARA Biosciences, Inc. (Nasdaq:DARA), today announced that the United States Food and Drug Administration ("FDA") has 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 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.
DARA's CEO, Richard A. Franco, Sr., stated: "With the current worldwide incidence of Type 2 Diabetes at around 6% and estimated to increase by 4-5% per year, it is anticipated that by 2030 the diagnosed patient population will be greater than 300 million. Given that these patients often present with imbalances in cholesterol and triglycerides in addition to elevated blood sugar levels, this milestone, with a candidate drug that has the potential to effectively treat both aspects of the disease is extremely important and exciting and paves the way for the first human clinical trial of DB959."
DARA plans to study DB959 as both monotherapy and in combination with other standard glucose lowering agents such as metformin, dipeptidyl-peptidase IV (DPP IV) inhibitors, sulphonylureas (SU), and metformin/SU combinations. 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. DB959 would be DARA's second therapeutic candidate to advance to the clinical trial stage. KRN5500 is nearing completion of a Phase 2a study for the treatment of neuropathic pain in cancer patients.
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.