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DARA BioSciences Announces Successful Completion of a Phase I Clinical Study of DB959 for the Treatment of Type 2 Diabetes

DB959 is a Highly Selective, Non-TZD
/ Source: GlobeNewswire

DB959 is a Highly Selective, Non-TZD

First-In-Class Dual PPAR-Delta/Gamma Agonist

DARA is Advancing Two Drugs From Its Portfolio Through Clinical Trials

RALEIGH, N.C., Nov. 4, 2010 (GLOBE NEWSWIRE)  -- DARA BioSciences, Inc. (Nasdaq:DARA) announced that it has successfully completed a Phase I clinical study for DB959, its PPAR (peroxisome proliferator activated receptor) delta/gamma agonist, an oral drug in development for the treatment of Type 2 Diabetes.  This study's main objectives were to determine the safety and pharmacokinetics of single ascending oral doses of DB959Na. Overall, the safety of DB959Na was comparable to placebo with no reports of moderate, severe, or serious adverse events in any subjects in the study.  Results of pharmacokinetic measurements indicate that the compound is likely to meet the target dosing regimen of once a day, thus meeting an important goal for the program. 

The study was a randomized, placebo-controlled, double-blind, escalating single dose study and enrolled 76 healthy male and female volunteers at Quintiles' Phase 1 facility in Overland Park, Kansas.  Dose escalation covered a 100-fold range in dose. The company plans to present detailed results at an upcoming scientific meeting in the first half of 2011. 

As presented earlier, results of preclinical studies demonstrated that DB959 controlled glucose while raising HDL and the HDL:LDL ratio and lowering triglycerides. These beneficial effects on glucose and lipids were observed without causing the weight gain which is seen with other PPAR agonists. Given the positive results seen in this clinical trial, the company plans to initiate a multiple ascending dose trial in the first half of 2011.

Steve Grossman, MD, Medical Consultant to DARA, said, "We have gained a considerable amount of valuable information from this trial, including detailed pharmacokinetic information to help guide future studies. In addition, our observation that these subjects tolerated a 100-fold range in doses of DB959Na with no moderate, severe, or serious adverse events suggests a very good safety profile."

Richard A. Franco, CEO of DARA, said, "We are very excited by the results of this clinical study of DB959, which is now DARA's second drug candidate to be in clinical development from our pipeline. This human clinical trial supports the earlier nonclinical results which suggested a good safety profile. These data will help advance our goal of providing patients with a product that offers unique advantages over current approaches to addressing Type 2 Diabetes.  These advantages include the potential for controlling dyslipidemia and an improved safety profile." 

About DB959

DB959 regulates certain nuclear receptors (peroxisome proliferator-activated receptors, PPARs) that regulate the genes involved in controlling blood sugar levels and certain lipids (e.g. total cholesterol, HDL-cholesterol, triglycerides).  The compound acts as an agonist of PPAR delta and PPAR gamma.

About DARA BioSciences, Inc.

DARA BioSciences, Inc. is a Raleigh, North Carolina based biopharmaceutical development company that acquires promising therapeutic candidates 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 (Investigational New Drug) Applications from the United States FDA. The Company has a pipeline of diverse drug candidates at various stages of development, with 82 granted patents and 56 pending applications (US and foreign). The first drug candidate KRN5500 has successfully completed a Phase 2 clinical trial treating neuropathic pain in patients with cancer. KRN5500 met its primary endpoint and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned during the first half of 2011. The second drug candidate DB959 is a highly selective, non-thiazolidinedione (TZD), first-in-class dual PPAR (peroxisome proliferator activated receptor) delta/gamma agonist in development for type 2 diabetes. A Phase 1 clinical study for DB959 is underway and the Company plans to announce results in the second half of 2010. In addition, DARA owns CPT-1 inhibitors intended for topical application for patients with psoriasis, a library of DDPIV inhibitors and a diverse library of approximately 1800 PPAR agonists of various molecular modalities. PPAR receptors are found throughout the human body and recent publications report that PPAR agonists may be useful in the treatment of Alzheimer's disease, cystic fibrosis, liver disease, and a variety of autoimmune diseases. Because its diverse PPAR library has the potential to address the unmet medical needs of these diseases, the Company plans to explore several of these indications.

For more information please contact the Company at 919-872-5578 or visit our web site at .

CONTACT: Cameron Associates, Inc. Kevin McGrath 212.245.4577