RALEIGH, N.C., April 7, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) a clinical biopharmaceutical drug development company, highlights a number of achievements disclosed in the Company's 2010 annual report that was filed with the Securities & Exchange Commission (SEC) on March 25, 2011 and provides an overview. For the year ending December 31, 2010, the Company received approximately $8.4 million in cash and funding commitments to continue the clinical development of its two leading drug candidates that have the potential to help people with neuropathic pain and those with diabetes. As a result of the capital raised during 2010, the Company believes it has sufficient cash to achieve the next series of key milestones during 2011.
DARA's two leading drug candidates have been successfully studied in clinical trials, and DARA is preparing for additional clinical studies during the first half 2011. Selected 2010 highlights include:
- Announcement of a Clinical Trial Collaboration Agreement with the Symptom Management & Drug Development, Community Oncology & Prevention Trials Group, Division of Cancer Prevention; National Cancer Institute (NCI) to advance the clinical study of KRN5500;
- Completion of a successful Phase 1a clinical study for DB959 program;
- Enhancement of patent portfolio to 88 granted patents and 60 pending applications (US and foreign);
- Receipt of equity investments in excess of $7.9 million, with CEO Richard A Franco Sr. personally investing approximately $350,000; and,
- Receipt of approximately $500,000 in grant awards.
2011 Clinical Development Outlook
Upon successful completion of a Phase 2a study of KRN5500 for the treatment of neuropathic pain in patients with cancer, DARA announced its partnership with the NCI to study the treatment and prevention of chemotherapy-induced peripheral neuropathy in cancer patients. NCI will fund the costs associated with conducting the Phase 2 study(s) of KRN5500, except for the costs associated with providing study drug. It is estimated that the market potential for chemotherapy-induced neuropathy alone will be roughly $2.5 billion. The second Phase 2 clinical trial is planned during the first half of 2011.
In addition, DARA successfully completed the first Phase 1 clinical study of DB959, the Company's other promising oral drug candidate which is being developed for the treatment of type 2 diabetes. As recently announced, DARA has initiated a multi-dose Phase 1b study of DB959. The Company expects to report results of the study during Q3 2011.
CEO Richard Franco stated that, "The Company achieved significant milestones both operationally and scientifically as we continued the advancement of our two key drug candidates and entered into a collaboration agreement with the National Cancer Institute."
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 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.