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DARA BioSciences Selected by the American Diabetes Association to Present Results of DB959 Phase I Study at the Upcoming 71st ADA Scientific Sessions

/ Source: GlobeNewswire

RALEIGH, N.C., April 21, 2011 (GLOBE NEWSWIRE) -- Today DARA BioSciences, Inc. (Nasdaq:DARA) announced that an abstract has been accepted for presentation at the annual American Diabetes Association ("ADA") Scientific Sessions to be held in San Diego, CA, June 24 - 28, 2011. The poster presentation will provide details on the company's lead once-a-day, oral diabetes drug candidate DB959 for which a Phase 1b clinical trial initiated Q1 2011.

The abstract entitled "DB959-101:  A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Escalating Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of DB959Na in Healthy Male and Female Volunteers," has been selected for presentation in the session on Clinical Therapeutics/New Technology – Pharmacologic Treatment of Diabetes or its Complications. 

Mary Kay Delmedico, Ph.D., Director of Drug Development/Portfolio Management at DARA said, "We are looking forward to presenting these encouraging results at the ADA meeting and the continued development of DB959."

About DARA BioSciences, Inc.

DARA BioSciences, Inc. is a clinical biopharmaceutical development company that acquires promising therapeutic candidates and develops them through proof of concept (pre-phase III) 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 advancing through clinical development:

  1. KRN5500 for the treatment of neuropathic pain – successfully completed a Phase II study and plans to initiate a second Phase II study (Q2 2011) in conjunction with the National Cancer Institute focusing on the treatment of chemotherapy induced peripheral neuropathy (CIPN); and
     
  2. DB959 for the treatment of type 2 diabetes – successfully completed a Phase Ia study and has initiated a Phase Ib study (Q1 2011).

In addition, the Company has a pipeline of diverse drug candidates at various stages of development, with 88 US and foreign granted patents and 60 pending applications. 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 of reduction of pain from baseline and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned during the first half of 2011. In addition, DARA has entered into a Clinical Trial Agreement with the National Cancer Institute to study the prevention and treatment of neuropathic pain in cancer patients. The second drug candidate DB959 is an oral, 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 1a clinical study has been completed and the positive results were announced. A second Phase 1 clinical study has commenced and the Company plans to announce results in the second half of 2011. 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.

Safe Harbor Statement

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 . 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: Investor Contact: Cameron Associates, Inc. Kevin McGrath 212.245.4577 Kevin@cameronassoc.com Media Contact: Wyatt Communications LLC MJ Wyatt 212 661-9610 mjwyatt@erols.com