Date: 2015-10-27
Type of information: Results
phase: 3
Announcement: results
Company: Macrocure (Israel)
Product: CureXcell®
Action
mechanism: cell therapy. CureXcell® is containing activated homologous white blood cells prepared from donated healthy whole blood. These cells have been activated to facilitate the healing process and stimulate wound closure.
Disease: diabetic foot ulcers
Therapeutic area: Metabolic diseases - Cardiovascular diseases - Regenerative Medicine
Country: Canada, Israel, USA
Trial
details: The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. A total of 280 patients will be randomized to receive either CureXcell® or sham. (NCT01421966)
Latest
news: * On October 27, 2015, Macrocure, a clinical-stage biotechnology company focused on advancing its novel therapeutic platform to address chronic and hard-to-heal wounds, 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® 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. * On September 2, 2014, Macrocure, a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, announced that it has completed enrollment in its pivotal, double-blind, Phase III clinical trial of CureXcell in diabetic foot ulcers. A total of 280 patients at 25 participating sites have been enrolled and randomized. The Company\'s second pivotal, Phase III clinical trial is studying CureXcell in venous leg ulcers. The VLU study initiated patient enrollment in May 2014. Interim data in the VLU study is expected in the second half of 2015 with the study expected to conclude in the second half of 2016.
CureXcell is currently in two pivotal, Phase III clinical trials for the treatment of chronic, hard-to-heal wounds below the knee. The first clinical trial is a multicenter, randomized, double-blind, parallel group, sham-controlled study of CureXcell in diabetic foot ulcers. The Company expects to announce study results in the second half of 2015.
