RALEIGH, N.C., Nov. 4, 2009 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) today announces that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (PTO) for U.S. Patent Application No. 12/112,213 entitled "Methods for Decreasing or Preventing Pain Using Spicamycin Derivatives." When issued, the patent will allow protection through 2021. DARA BioSciences has exclusive licenses with Massachusetts General Hospital and Kirin Pharmaceuticals of Japan for the treatment of pain with Spicamycin derivatives.
DARA currently has a patent estate with ownership, rights and licenses to 71 patents and 58 patent applications worldwide, covering the drug candidates in development plus its extensive libraries.
Earlier this year, DARA successfully completed a clinical proof-of-concept study for the treatment of neuropathic pain in patients with advanced cancer using KRN5500. This 14 week, multi-center, double-blind, placebo-controlled dose escalation study randomized patients to receive treatment with either KRN5500 or placebo (saline equivalent) in doses ranging from 0.6 to 2.2 mg/m(2). The Primary Endpoint was achieved with demonstrating statistical significance over Placebo (p=0.03) in the median reduction of pain scores from baseline.
The results of this Phase 2 study will be presented as a poster, "KRN5500 Demonstrates Significant Reduction in Neuropathic Pain Intensity in Patients with Cancer" at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain to be held in San Francisco, November 19-21, 2009. Sharon M. Weinstein, MD, a leading investigator in the study, will present the poster.
A Notice of Allowance generally completes the substantive examination of a patent application. The normal process which results in final issuance of a United States patent involves several administrative steps that are typically completed in due course following issuance of such a notice.
About DARA BioSciences, Inc.
DARA BioSciences, Inc. is a Raleigh, North Carolina based development-stage biopharmaceutical company that acquires promising therapeutic small molecules 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's (Investigational New Drug) Applications from the U.S. FDA. One of these drug candidates KRN5500 has successfully completed a Phase 2a clinical trial treating cancer patients for neuropathic pain. It has a portfolio of drug candidates for neuropathic pain, type 2 diabetes, and psoriasis. For more information please contact the Company at 919-872-5578 or visit our web site at http://www.darabio.com.
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.