DARA BioSciences Selected to Present Positive Results of KRN5500 Phase 2 Study

DARA BioSciences DARA announced today that the Company has been selected to present the positive clinical data results for KRN5500, its lead compound for Neuropathic Pain, at the 5th Annual Therapeutics Summit to be held September 20-21, 2011 in San Francisco. Linda Jett, MSN, Clinical Director, Drug Development at DARA, will present a poster entitled, "Management of Placebo Response Yields Proof of Concept in Randomized Trial of KRN5500 in Patient with Neuropathic Pain and Cancer." The presentation will provide results from analyses of a recently completed randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate safety and efficacy of a novel spicamycin derivative, KRN5500, in patients with advanced cancer experiencing neuropathic pain. Placebo response in these types of studies often dilutes the ability to detect potential drug effects. The presentation will explore the ramifications of placebo response in randomized, controlled trials for analgesia. It is common that patients respond to the placebo in pain trials where subjective outcome data are collected. Patients want to feel better. The placebo effect is a normal physiological event and can be as high as 40% to 50%, requiring an even higher drug effect to show a difference. The placebo response can be thought of as background noise, and what researchers look for is a clinical benefit over and above what is in that background. Researchers are often faced with a dilemma: Is the drug a failure or is the placebo response too great to see the drug response? Often clinical trials must be quite large in order to detect the potential benefit of active treatment over placebo. Although this particular trial had only 19 patients, it had a low placebo response, enabling the positive KRN5500 results to be more easily interpreted. The KRN5500 program was recently granted Fast Track designation for treatment of chemotherapy-induced neuropathic pain by the U.S. FDA. The Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical need.