Human Genome Sciences Inc reported that a Phase 2 clinical trial of topically administered repifermin (keratinocyte growth factor-2, KGF-2) in adults with chronic venous ulcers did not meet its primary endpoint. Efficacy was measured in the trial as the percentage of patients achieving complete wound closure within 20 weeks of initiating treatment.
The percentage of patients treated with repifermin at doses of 60 and 120 mcg per square centimeter of wound area who achieved complete wound closure within the 20-week timeframe was not statistically significantly different from placebo, nor was there any favorable trend for the repifermin-treated groups.
The 352 patients who were randomized in the multi-center double-blind placebo-controlled trial had chronic venous ulcers from 3 to 25 square centimeters in size that had persisted unhealed for 3 to 36 months prior to enrollment. All patients received standardized compression therapy and wound care for the duration of the study. Repifermin was well tolerated with a safety profile similar to placebo. There also were no significant differences between repifermin and placebo on prespecified secondary endpoints of time to complete wound closure or complete wound closure by 16 or 26 weeks of treatment.
David C. Stump, Senior Vice President, Drug Development, said, "Given the prior results with repifermin in this patient population, we are disappointed in the efficacy results from this study. We are especially disappointed for the many patients in need who could benefit from the availability of improved treatment options for this difficult medical problem. However, in my opinion, the level of evidence is now not sufficient to warrant our further development of repifermin for use in the treatment of chronic venous ulcers."
A Phase 2 trial of the use of repifermin for the treatment of cancer therapy-induced mucositis is still ongoing.