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%;>
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.
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