DARA BioSciences, Inc. (Nasdaq:DARA) announced today additional positive results from its successfully completed KRN5500 Phase 2a Clinical Study for treatment of neuropathic pain in patients with cancer. Statistically significant primary endpoint results were released earlier.
More than 80% of patients in this clinical study had allodynia, which is an abnormal pain response to normally non-painful stimuli, such as light touch or temperature changes. Even the light pressure of clothing against the skin or a cold breeze can cause severe pain in patients with neuropathic pain. Clinicians conducted 2 weekly examinations to determine if KRN5500 was effective in reducing allodynia. For both tests, patients rated their pain on a Numeric Rating Scale of 1 to 10 (1 = no pain/10 = worst pain imaginable), both before the targeted area was stimulated and right afterward.
The KRN5500 treatment group showed a larger median decrease in pain associated with both touch and cold (both touch and cold 33%) compared to placebo (0 and 8%, respectively).
DARA also announced that over the past 12 months, it has expanded its patent portfolio by 11 US and Foreign granted patents. Today, DARA has a portfolio of over 80 granted patents worldwide further strengthening its intellectual property position.
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 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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SOURCE: DARA BioSciences, Inc.
CONTACT: Cameron Associates, Inc.