RALEIGH, N.C., Feb. 1, 2011 (GLOBE NEWSWIRE) -- The Company (Nasdaq:DARA) announced that the University of Rochester in concert with ADEPT has selected the study results from the KRN5500 Phase 2 study to be presented at its March 25-26, 2011 conference. The presentation is entitled, "Management of Placebo Response in a Randomized Trial of KRN5500 in Patients 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.
About KRN5500 and Neuropathic Pain
KRN5500 is a novel non-opioid analgesic agent, a semi-synthetic derivative of spicamycin:(6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl]amino-L-glycero-beta-L-manno-heptopyranosyl]amino-9H-purine). Neuropathic pain has multiple etiologies, including direct nerve trauma, infectious disease (e.g., herpes zoster), metabolic disease (e.g., diabetes) and drug-induced neuropathies (e.g., chemotherapy). Chronic neuropathic pain is characterized by an abnormal hypersensitivity to innocuous as well as noxious stimuli, and often persists after initial tissue damage and inflammation appear to have healed. Painful neuropathy is more commonly caused by non-traumatic conditions than by direct nerve trauma. Prevalence of neuropathic pain in patients that have been treated for cancer is reported to be in the range of 40%. Neuropathic pain in this population has multiple etiologies, including side effects from cancer treatments. Chemotherapy-induced Peripheral Neuropathy is the most common cause of neuropathic pain in patients with cancer, and in particular, for those patients receiving multi-agent chemotherapy. Clinically, neuropathic pain is difficult to manage and can have a profound impact on quality of life. Although this type of pain sometimes responds well to standard analgesic treatments, currently approved therapeutic agents can have intolerable side effects that prevent reaching the most effective dose. Thus, there is continued need to develop safe and more effective drugs to treat chronic neuropathic pain.
About DARA BioSciences, Inc.
DARA BioSciences, Inc. is a Raleigh, North Carolina based biopharmaceutical development company that acquires promising therapeutic candidates 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 (Investigational New Drug) Applications from the United States FDA. The Company has a pipeline of diverse drug candidates at various stages of development, with 82 granted patents and 56 pending applications (US and foreign). 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 and was statistically significantly (p=0.03) better than placebo. A second Phase 2 clinical trial is planned during the first half of 2011. The second drug candidate DB959 is a 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 for DB959 was successfully completed in 2010 with a multiple ascending dose trial planned for the first 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.
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