RALEIGH, N.C., March 25, 2010 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) announced that it has initiated 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. The study will enroll approximately 75 volunteers and will be conducted at Quintiles' Overland Park facility. This study's main objectives are to determine the safety and pharmacokinetics of single ascending oral doses of DB959. The Company expects to report the results of the study during the second half of 2010.
The 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.
Richard A. Franco, CEO of DARA said, "We are proud of the initiation of this clinical study of DB959, which is now DARA's second drug candidate to be in clinical development from our pipeline. We are excited about the potential of this compound and that early results have supported 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. We recently reported that our first clinical candidate, KRN5500, successfully completed a Phase IIa study, which demonstrated that KRN5500 was statistically significantly better than placebo in reducing neuropathic pain in patients with cancer."
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 (U.S. and foreign). The first drug candidate KRN5500 has successfully completed a Phase 2 clinical trial treating cancer patients for neuropathic pain. KRN5500 met its primary endpoint and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned to start during the second half of 2010. 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 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 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.
CONTACT: Cameron Associates, Inc.
Kevin McGrath
212.245.4577
Kevin@cameronassoc.com
