Macrocure Says Phase III Clinical Trial of CureXcell in Venous Leg Ulcers Not Expected to Meet Primary Endpoint.

Macrocure Ltd.

announced Wednesday, that a pre-specified, futility analysis conducted by the Data Safety Monitoring Board for CureXcell® – the Company's lead product candidate in its Phase 3 pivotal clinical study (MC-105) for venous leg ulcers (VLU) – determined that this study is not expected to meet its primary endpoint. "While we are disappointed with the results of the VLU futility analysis, given the positive clinical outcomes seen in our experience with more than 5,000 patients in Israel, we continue to believe that the technology has clinical merit for patients with chronic and other hard-to-heal wounds," said Nissim Mashiach, President and Chief Executive Officer of Macrocure. "We will evaluate the data collected to date in the MC-105 study to determine an appropriate course of action, including the potential initiation of a third Phase 3 study in patients with chronic wounds below the knee. We intend to work closely with the FDA to complete all additional clinical trial work required to pursue the approval and commercialization of CureXcell. Macrocure remains