DARA BioSciences to Present Results of a Phase 2 Clinical Study for KRN5500 at the "Third International Congress on Neuropathic Pain"

Discussion of Methods From the KRN5500 Study for Treatment of Neuropathic Pain in Patients With Cancer: Primary Endpoint Met in 2009


RALEIGH, N.C., April 20, 2010 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) announced today that the company has been selected by the Scientific Programme Committee to present results from its Phase 2 study at the Congress on May 29, 2010 in Athens, Greece.

Linda Jett, MSN, Clinical Director, Drug Development, DARA BioSciences will present a poster entitled, "Correlation of Numeric Rating Scale (NRS), Neuropathic Pain Questionnaire (NPQ), and Keywords in Study for Treating Neuropathic Pain with KRN5500."

The poster presentation will provide an overview of keywords used by patients in describing their neuropathic pain and the correlation between post-treatment NRS scores and NPQ symptom scores. Baseline correlation was significant for electric (r=0.50), "sensitive to touch" (r=0.58), shooting (r=0.56) and tingling (r=0.55).  However, NPQ symptom scores did not correlate post-treatment with the statistically significant improvement seen in the NRS pain scores (combined symptoms). The largest median decrease in NRS scores in patients treated with KRN5500 was 29.3% while the median decrease for patients treated with placebo was zero.

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-B-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 as high as 40%.  Neuropathic pain in this population has multiple etiologies, including tumor compression and side effects of treatment. Chemotherapy Induced Peripheral Neuropathy (CIPN) is the most common cause of neuropathic pain in patients with cancer, and in particular, for those patients receiving multiagent 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, very frequently, the response is less than complete, and currently approved therapeutic agents often have intolerable side effects as well. 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 (U.S. and foreign). The first drug candidate KRN5500 has successfully completed a Phase 2 clinical trial treating cancer patients for neuropathic pain. 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 second half of 2010. 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 http://www.darabio.com.



            

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