RALEIGH, N.C., May 12, 2009 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) today announced positive results from a Phase 2a clinical trial of KRN5500 for treatment of neuropathic pain in patients with advanced (recurrent) cancer. KRN5500 demonstrated efficacy in this study designed to assess the analgesic activity, duration of effect, safety and tolerability of KRN5500 in patients with neuropathic pain. The primary efficacy endpoint was defined by the average pain intensity over the previous 24 hours as measured by a standard numeric rating scale ("NRS") ranging from 0 to 10 collected weekly at each clinic visit, where 0 represents "no pain" and 10 represents the "worst possible pain."
This 14 week, multi-center, double-blind, placebo-controlled dose escalation study randomized 19 patients to receive treatment with either KRN5500 or placebo (saline equivalent) in doses ranging from 0.6 to 2.2 mg/m(2). Twelve (12) patients received KRN5500, and 7 received placebo. The primary outcome demonstrated KRN5500 to have a clear clinical benefit over placebo in this study. The median percentage decrease from baseline in pain scores was 23% in the KRN5500 group compared to 0% decrease in the placebo group (p=0.03). Of the 12 patients receiving KRN5500, 8 (67%) had improved pain scores with one patient showing 100% improvement (range: 12.5% to 100 % with a mean decrease in clinical NRS from baseline of 36.8%). Four (4) had no change in pain response. Of the 7 patients receiving placebo, 2 (29%) reported a decrease in NRS pain scores (range: 12.5% to 20 %), while 4 showed no change and 1 patient reported increased pain (25% increase).
"Chemotherapy-induced neuropathic pain occurs in approximately 40% of patients treated with polychemotherapy and is an urgent unmet medical need. Therefore, these results are very encouraging," said Linda Jett, MSN, RN, leader of the KRN5500 program at DARA.
Amy Abernethy, MD, is Program Director of the Duke Cancer Care Research Program, Associate Professor of Medicine with Tenure in the Division of Medical Oncology at Duke University Medical Center. Dr. Abernethy, one of nine Principal Investigators enrolling patients in the study, stated, "Unfortunately, neuropathic pain often responds poorly to presently available standard pain treatments and may worsen instead of improve over time. Too often, relentless pain can lead to serious disability. Neuropathic pain is a complex, chronic pain state that usually begins with known injury, but can linger even after healing of the initial injury. With neuropathic pain, the nerve fibers themselves may be damaged or dysfunctional, incorrectly signaling to other pain centers. Known common causes of neuropathic pain include: chemotherapy, diabetic neuropathy, HIV Infection, AIDS and Shingles. In cases that are difficult to treat, a pain specialist may treat with opioids, neuroleptics, or use invasive, implantable device therapies."
According to Isadore Pike, MD, medical oncologist and safety advisor and consultant to DARA for this study, "KRN5500 was well tolerated by the people enrolled in this trial. Overall, there were no major safety concerns with KRN5500 administration. The predominant adverse events were gastrointestinal disturbances evidenced by nausea, vomiting, and, less frequently, diarrhea. These events were generally mild to moderate and, although occurring in patients receiving either placebo or KRN5500, were seen less frequently in the group receiving placebo. Otherwise, KRN5500 was well tolerated." DARA has begun work on reformulation of KRN5500 in an effort to lessen these previously known GI side effects.
About DARA BioSciences, Inc.
DARA BioSciences(tm), Inc. ("DARA") is a Raleigh, North Carolina based development-stage pharmaceutical 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. It has a portfolio of drug candidates for neuropathic pain, type 2 diabetes, and psoriasis. Presently the Company has two drug candidates that are the subject of effective INDs (DB959 and KRN5500). DARA is in the process of seeking to raise working capital to advance the development of these two candidates, among other uses of such working capital.
For more information please contact DARA at 919-872-5578 or visit our web site at 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 the near term in order to be able to continue to fund its operations, 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. 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.