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DARA Announces Analytical Results in Efficacy and Dose Response of KRN5500 in Patients with Chemotherapy Induced Peripheral Neuropathy and Advanced Cancer

RALEIGH, N.C., Sept. 8, 2010 (GLOBE NEWSWIRE) -- DARA BioSciences (Nasdaq:DARA) announced today that it presented study results from its Phase 2 multicenter, placebo controlled, double-blind, randomized dose escalation study for KRN5500 at the 13th World Congress on Pain held recently in Montreal.
/ Source: GlobeNewswire

RALEIGH, N.C., Sept. 8, 2010 (GLOBE NEWSWIRE) -- DARA BioSciences (Nasdaq:DARA) announced today that it presented study results from its Phase 2 multicenter, placebo controlled, double-blind, randomized dose escalation study for KRN5500 at the 13th World Congress on Pain held recently in Montreal.

The study was designed to evaluate the safety and efficacy of KRN5500 for treatment of neuropathic pain in patients with cancer, and primary endpoint results from the study have previously been released.

Prevalence of Chemotherapy-induced Peripheral Neuropathy (CIPN) is reported to be as high as 38% in patients who receive multi-agent chemotherapy. Presently, there is no approved treatment for this indication; thus, exploratory analyses of a subset of study patients with CIPN (17 of 19 total) provides clinically meaningful information regarding KRN5500 as potential treatment for CIPN.

Wilcoxon Rank Sum test was used to compare treatment differences in median changes from baseline in pain scores recorded by patients in a daily diary.

KRN5500 significantly reduced neuropathic pain when compared to placebo (27% vs. 0%; p = 0.03) when looking at best response to treatment regardless of dose or timing. For the best response within 7 days of last treatment given, the difference was in favor of KRN5500, but was not statistically significant (16% vs. 0%; p=0.19). In addition, regression analysis of the best response for each patient over doses showed a significant linear decrease in pain intensity with increase in dose (slope = -18.2; p = 0.009).

Results of these analyses indicate that KRN5500 was effective in reducing pain in patients with CIPN; and a dose-response relationship was established, with higher doses resulting in greater reductions in pain. In addition, KRN5500 was generally well tolerated with adverse reactions limited to nausea and vomiting. 

Earlier this year the National Cancer Institute and DARA entered into a clinical trial collaboration to further study KRN5500 for the treatment of CIPN.

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 proof-of-concept Phase 2 clinical trial for 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 1 clinical study for DB959 is underway and the Company plans to announce results in the second half of 2010. 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.

For more information please contact the Company at 919-872-5578 or visit our web site at .

CONTACT: Cameron Associates, Inc. Kevin McGrath 212.245.4577