PETACH TIKVA, Israel, Oct. 27, 2015 (GLOBE NEWSWIRE) -- Macrocure Ltd. ("Macrocure" or the "Company") (NASDAQ:MCUR), a clinical-stage biotechnology company focused on advancing its novel therapeutic platform to address chronic and hard-to-heal wounds, 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.
About CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes:
Official Title: A Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus (https://clinicaltrials.gov/ct2/show/NCT01421966)
Primary Outcome Measures:
Secondary Outcome Measures:
About Macrocure Ltd.
Macrocure Ltd. is a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, such as diabetic foot ulcers and venous leg ulcers. The Company's approach is to treat and close chronic and other hard-to-heal wounds by injecting the human body's own wound healing and regenerative components directly into the wound itself.
Macrocure's lead product candidate, CureXcell, is a unique combination of living human white blood cells that have been activated to facilitate the healing process and stimulate wound closure. CureXcell addresses each phase of healing in the impaired wound, including the production of growth factors and other biochemical factors involved in fibroblast activation, cell migration and extracellular matrix production, stimulating the body's natural healing process. CureXcell is currently completing two pivotal Phase III, double-blind clinical trials targeting a broad indication for the treatment of all types of wounds below the knee. CureXcell has been approved in Israel. For more information, please visit: www.macrocure.com.
About Diabetic Foot Ulcers
Diabetic foot ulcers are red sores that can occur most often on the pad (ball) of the foot or the bottom of the big toe. Ulcers can also form from poorly fitted shoes, especially on the sides of the foot, the tops of the toes, or the heel of the foot (Source http://www.webmd.com/diabetes/diabetic-foot-ulcer).
For Further Information, please contact: David Carey Lazar Partners Ltd. (212) 867-1762