updated 4/5/2011 8:46:03 AM ET 2011-04-05T12:46:03

RALEIGH, N.C., April 5, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) announced that it has initiated a Phase Ib 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 promising and exciting results from the Phase Ia study and the pre-clinical studies prompted us to initiate this clinical study as soon as possible," said Mary Kay Delmedico, Ph.D., Director of Drug Development and Portfolio Management at DARA. This study's main objectives are to determine the safety and pharmacokinetics of multiple ascending oral doses of DB959Na in both male and female subjects. The Company expects to report the results of the study during Q3 2011.

The results of a Phase Ia study revealed a promising safety profile, even when dosed at 10X the anticipated human daily dose and a pharmacokinetic profile that supports a once-a-day oral dose. In addition, the 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 second clinical study of DB959, which is DARA's second drug candidate in clinical development from our pipeline. On the heels of the first successful Phase II trial, we plan to initiate a second Phase II study for KRN5500 for the treatment of painful chemotherapy induced peripheral neuropathy in patients with cancer during the first half 2011. Advancing two important drug candidates through clinical development for our company is especially gratifying."  

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 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 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 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 an y 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 Contacts:
         Wyatt Communications LLC
         MJ Wyatt
         212 661-9610
         mjwyatt@erols.com
         or
         Arthur Solomon
         914 472-6598
         arthursolomon4pr@juno.com

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