PETACH TIKVA, Israel – April 30, 2012 – Macrocure (www.macrocure.com), a biotechnology company developing and selling advanced cell therapy products, announced today it has achieved positive results for a “Real Life” Phase IV trial of its lead product, CureXcell®, for the treatment of hard-to-heal ulcers in a community care setting.
The recently-completed trial aimed to evaluate the safety and efficacy of CureXcell® for a variety of hard-to-heal ulcers and was conducted in 131 subjects at seven different clinics at the Clalit Heath Service facilities, Israel's largest HMO.
Trial results, presented at last week's Symposium on Advanced Wound Care (SAWC) Spring conference in Atlanta, Georgia, support the broad spectrum efficacy and safety of CureXcell, and included 68% and 81% and complete closure rates for diabetic foot ulcers (DFU) and venous ulcers, respectively, at 24 weeks. Overall the complete closure rate for all ulcers was about 71% and the median time to complete closure was about 12 weeks.
"The Macrocure team has worked extremely hard to develop and bring to market a cell therapy for hard-to-heal wounds, and we are confident that CureXcell is the best solution available today," said Mitchell Shirvan, chief executive officer of Macrocure. "This trial, in the community care setting, presented a truly challenging environment to test our therapy, and I am pleased with our results."
"Satisfying the primary objective for these studies in order to better define procedures and indices for wound healing in the HMO environment in the Phase IV clinical trial program signals significant progress in establishing the potential of CureXcell,” said Dr. Nicky Liebermann, Head, Community Medicine Division, Clalit Health Services. "This trial demonstrated both Clalit's and Macrocure's commitment to address the unmet needs of patients and improve their quality of life by providing innovative medicines and devices."
CureXcell is also currently undergoing a Phase III randomized, double-blind trial for lower extremity chronic ulcers in adults with diabetes in the United States, Canada and Israel. This product has marketing authorization in Israel for the treatment of chronic ulcers, but is not yet licensed for sale in either the United States or Canada.
CureXcell® is a novel approach to treating hard-to-heal wounds by replenishing the imbalanced inflammatory environment in non-healing wounds with a broad array of functionally-active allogeneic immune cells. These cells release the necessary cytokines and growth factors for the wound to heal. About 5,000 patients with various types and severities of hard-to-heal wounds have been treated in Israel and CureXcell® has been approved for reimbursement by the Israeli Ministry of Health.
Macrocure is a biotechnology company which focuses on the development and commercialization of advanced wound care therapies. Macrocure is pursuing regulatory market approval in North America and Europe.
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