updated 3/25/2011 4:46:24 PM ET 2011-03-25T20:46:24

RALEIGH, N.C., March 25, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (the "Company") (Nasdaq:DARA) today announced that it has filed a universal shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC). The registration statement will replace a registration statement set to expire on April 18, 2011 and is intended to provide the Company with financial flexibility for future growth and does not reflect a change in its financing strategy. At present, the Company has no specific plans to issue securities under the registration statement. In December 2010, the Company successfully completed a $4.8 million preferred stock and warrant offering and it believes it has sufficient cash to complete its key clinical milestones in 2011.

When the registration statement is declared effective by the SEC, DARA Biosciences will be able to offer and sell up to $30 million of securities, including equity, debt and other securities as described in the registration statement. The terms of any offering under the shelf registration statement will be determined at the time of offering. Proceeds from the sale of any securities will be used for the purposes described in a prospectus supplement filed at the time of an offering.

The registration statement has been filed with the SEC, but has not yet become effective.  These securities may not be sold nor may offers to buy these securities be accepted prior to the time the shelf registration statement becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offering of the securities covered under the shelf registration statement will be made solely by means of a prospectus and an accompanying prospectus supplement relating to that offering.

About DARA BioSciences, Inc.

DARA BioSciences, Inc. is a 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 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 plans to initiate 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 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 1 clinical study has been completed and the positive results were announced earlier this year. A second Phase 1 is planned to commence in the first quarter 2011 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 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 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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