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 (p=0.03). Study results showed KRN5500 to be both statistically and clinically significant in alleviating neuropathic pain, reaching its primary end-point reduction of pain from baseline.

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.