DARA's KRN5500 meets primary end-points in Phase II study for chemotherapy-induced neuropathic pain

Thanks to greater awareness, earlier detection and improving therapeutic agents, people with cancer are living longer than ever before. One of the consequences of living longer is the symptom burden of cancer survivorship, which may have a substantial impact on quality of life for many survivors. One such burden is the pain syndromes resulting from cancer treatments. Chemotherapy-induced neuropathic pain is a neurotoxic effect of some chemotherapeutic agents such as paclitaxel, vincristine, cisplatin, oxaliplatin, thalidomide and bortezomib.

DARA BioSciences, Inc. (NASDAQ: DARA) is studying a new medication, KRN5500, for neuropathic pain in cancer patients and has reported positive results from a Phase II study. KRN5500 met its primary end-points of reduction of pain and safety.

KRN5500 is a novel spicamycin derived, non-narcotic/non-opioid/non-narcotic, analgesic agent produced by Streptomyces alanosinicus. A completed Phase II (DTCL100), double-blind, placebo-controlled, randomized, dose escalation study yielded positive results. The purpose of the study was to determine safety and efficacy of KRN5500 as treatment for neuropathic pain in patients with advanced cancer and neuropathic pain.

KRN5500 met its primary endpoints of safety and reduction of pain and was superior to placebo.

As a result of the promising results of the first Phase II study and the urgent unmet medical need, the National Cancer Institute (NCI) entered into a Clinical Trials Agreement with DARA to further study KRN5500 for the prevention and treatment of chemotherapy-induced neuropathic pain in patients with cancer (CIPN). This study, in 40 patients, is planned to begin in 2011. Under this Agreement, the NCI will fund the costs of the study and DARA will supply drug and placebo. NCI will utilize its established national network of investigators (Community Clinical Oncology Program - CCOP) to conduct the study.

The U.S. FDA recently granted the KRN5500 program Fast Track designation for treatment of chemotherapy-induced neuropathic pain. 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. Fast Track, Accelerated Approval and Priority Review information can be found at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm.

"The FDA Fast Track designation for KRN5500 is a significant positive step for the thousands of cancer patients who suffer this unremitting pain from a number of causes including from their chemotherapy," said Richard A. Franco, RPh, Chairman and CEO of DARA BioSciences. "This is a most serious condition in need of new treatment options. Current estimates show as many as 40-50% of cancer patients receiving chemotherapy endure this condition and a certain portion of these patients endure relentless chronic pain requiring treatment even after they recover from their cancer. CIPN is also a dose limiting side effect of many commonly used chemotherapeutics. We are very encouraged by the initial clinical results, our partnership with the National Cancer Institute (NCI) and now the FDA Fast Track Drug status," he added.

Source DARA BioSciences, Inc.

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