RALEIGH, N.C., Nov. 10, 2009 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA), a biopharmaceutical development company, presented preclinical data for DB959, its lead compound for Type 2 Diabetes (T2D), that demonstrated superior performance to comparator drugs at the Cambridge Healthtech Institute's Conference, "Targeting Diabetes with Novel Therapeutics" held November 3 - 4, 2009 in Boston, MA. Mary Kay Delmedico, Ph.D., DARA's Project Leader/Program Manager reviewed DB959's favorable pharmacological and safety profile as a unique first-in-class peroxisome proliferator-activated receptor (PPAR)-delta/gamma agonist without PPAR-alpha activity.
Delmedico explained, "Our previous data demonstrated that DB959 lowers blood sugar, raises HDL, raises the HDL:LDL ratio, and lowers triglycerides, while having a very favorable safety profile in rats and monkeys, particularly with regard to weight gain. These new data demonstrate that DB959's unique dual activation of the PPAR-delta and gamma subtypes leads to superior performance in preclinical models over agonists with dual activation of PPAR-gamma/alpha. The development of dual alpha/gamma agonists has been an active area of research and development in this field for years, but our data suggest that DB959 may be a better approach to developing a drug for patients with T2D. The majority of these patients need glucose control and improvements in cholesterol and triglyceride levels. Importantly, the delta activation appears to counteract the weight-gain side effect seen with PPAR-gamma and PPAR-gamma/alpha activation. With DB959, weight gain was not an issue in these preclinical studies."
"Worldwide diabetes is a growing problem, with most patients not achieving recommended targets for control of blood sugar and lipids. This situation demands improved treatments targeting the multidimensional aspect of this disease. We will continue to move DB959 forward in development as it continues to show the potential to address the unmet needs for these patients," says Richard A. Franco, R.Ph., Chief Executive Officer and President.
About DB959
DB959 is a unique, dual peroxisome proliferator activated receptor ("PPAR") delta/gamma agonist and is being developed for the treatment of Type 2 Diabetes Mellitus (T2D).
In March 2009, the United States FDA cleared the Company's IND for DB959, allowing DARA to commence Phase 1 studies in humans; DB959 will be the first PPAR compound in development with this subtype profile. The Phase 1 studies are planned for the first half of 2010. DARA plans to develop DB959 as a once-a-day oral medication alone and in combination with other approved medicines. DB959 is a non-thiazolidinedione (non-TZD), it does not have PPAR-alpha activity, and it is unique from Avandia(R) and Actos(R) both in structure and activity.
About DARA BioSciences, Inc.
DARA BioSciences, Inc. is a Raleigh, North Carolina based development-stage biopharmaceutical 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. Presently DARA has two drug candidates with cleared IND's (Investigational New Drug) Applications from the U.S. FDA. One of these drug candidates KRN5500 has successfully completed a Phase 2a clinical trial treating cancer patients for neuropathic pain. 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 http://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 order to be able to continue to fund its operations, risks and uncertainties relating to the potential delisting of DARA's common stock from the NASDAQ Capital Market, 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 ("SEC"). 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.