CureXcell shows its ability to treat hard-to-heal ulcers
Macrocure says it has achieved positive results for a âReal Lifeâ Phase IV trial of its lead product, CureXcell, for the treatment of hard-to-heal ulcers in a community care setting.
The recently-completed Phase IV hard-heal wound 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. Results from the trial showed 68 per cent and 81 per cent complete closure rates for diabetic foot ulcers (DFU) and venous ulcers, respectively, at 24 weeks. Overall the complete closure rate for all ulcers was approximately 71 per cent and the median time to complete closure was about 12 weeks.
CureXcell treats 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.
The CureXcell treatment is also currently being studied in a Phase III randomised, double-blind trial for lower extremity chronic ulcers in adults with diabetes in the US, Canada and Israel. This product has marketing approval in Israel for the treatment of chronic ulcers, but is not yet licensed for sale in North America.