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news.Median percentage decrease from baseline in pain scores was 23% in KRN5500 group compared to 0% decrease in placebo group
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US-based pharmaceutical company Dara BioSciences has reported positive results from a Phase IIa clinical trial of KRN5500 for treatment of neuropathic pain in patients with advanced cancer.
KRN5500 demonstrated efficacy in this study designed to assess the analgesic activity, duration of effect, safety and tolerability of KRN5500 in patients with neuropathic pain.
The primary efficacy endpoint was defined by the average pain intensity over the previous 24 hours as measured by a standard numeric rating scale (NRS) ranging from zero to 10 collected weekly at each clinic visit, where zero represents ‘no pain’ and 10 represents the ‘worst possible pain’.
This 14 week, multi-center, double-blind, placebo-controlled dose escalation study randomized 19 patients to receive treatment with either KRN5500 or placebo (saline equivalent) in doses ranging from 0.6 to 2.2mg/m(2).
Approximately 12 patients received KRN5500, and seven received placebo. The primary outcome demonstrated KRN5500 to have a clear clinical benefit over placebo in this study. The median percentage decrease from baseline in pain scores was 23% in the KRN5500 group compared to 0% decrease in the placebo group (p=0.03), the company said.
Of the 12 patients receiving KRN5500, eight (67%) had improved pain scores with one patient showing 100% improvement (range: 12.5% to 100 % with a mean decrease in clinical NRS from baseline of 36.8%). Approximately four had no change in pain response. Of the seven patients receiving placebo, two (29%) reported a decrease in NRS pain scores (range: 12.5% to 20 %), while four showed no change and one patient reported increased pain (25% increase).
Isadore Pike, medical oncologist and consultant to Dara for this study, said: KRN5500 was well tolerated by the people enrolled in this trial. Overall, there were no major safety concerns with KRN5500 administration. The predominant adverse events were gastrointestinal disturbances evidenced by nausea, vomiting, and, less frequently, diarrhea.
These events were generally mild to moderate and, although occurring in patients receiving either placebo or KRN5500, were seen less frequently in the group receiving placebo. Otherwise, KRN5500 was well tolerated.