RALEIGH, N.C., April 19, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA), reported today that SurgiVision, Inc. ("SVI"), a privately held company and a leader in interventional MRI-guided systems of which DARA owns over 500,000 shares and warrants, has received clearance from the Food and Drug Administration (FDA) for their SmartFlow™ neuro ventricular cannula.
The SmartFlow cannula is an MRI-compatible injection and aspiration cannula for use in the brain. It is compatible with SVI's ClearPoint® system which allows neurosurgeons to select a neurological target, navigate the SmartFlow cannula to the target and observe the delivery of the therapeutic agent. Another feature of the SmartFlow cannula includes a multi-step tip design to help prevent reflux along the cannula shaft.
For more information about SurgiVision, Inc., please visit: http://www.surgivision.com.
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:
-
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
- 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, the potential delisting of DARA's common stock from the NASDAQ Capital Market, DARA's limited operating history which may make it difficult to evaluate DARA's business and future viability, DARA's ability to retain its managerial personnel and to attract additional personnel, DARA's ability to successfully develop and outlicense its drug candidates 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, potential product liability risks that could exceed our liability coverage, competition from other pharmaceutical companies, biotechnology companies and other research and academic institutions, 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.