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Macrocure (MCUR) Phase III Clinical Trial of CureXcell Missed Primary Endpoint

Macrocure Ltd. (NASDAQ: MCUR) today announced that results from a pivotal Phase 3 multicenter, randomized, double-blind, parallel-group, sham-controlled study (MC-102) of CureXcell® in the treatment of diabetic foot ulcers (DFUs) did not meet its primary endpoint. CureXcell, the Company’s lead product candidate, did not show a statistically significant proportion of subjects with complete closure at 16 weeks and sustained complete closure for four additional weeks. In addition, CureXcell did not meet the secondary endpoints of the study.
“We plan to further analyze data from this Phase 3 study of CureXcell in DFU to understand why this trial did not meet its study endpoints, and determine the potential ongoing merits of the underlying technology,” said Nissim Mashiach, President and Chief Executive Officer of Macrocure. “With today’s announcement, we remain focused on the interests of all stakeholders of Macrocure and are committed to maximizing the value of the Company. Therefore, we will analyze all strategic options for the Company and continue to focus on managing and conserving our existing cash,” Mr. Mashiach concluded.
As of September 30, 2015, the Company had a preliminary estimated and unaudited cash balance of approximately $30 million. The Company had no debt outstanding.