, a biotechnology company developing advanced cell therapy products, announced 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.
CureXcell is made with white blood cells from healthy donors. It helps treat hard-to-heal wounds by replenishing the imbalanced inflammatory environment with a functionally-active allogeneic immune cells. These cells release the necessary cytokines and growth factors for the wound to heal.
The recently-completed trial was conducted at seven different clinics at the Clalit Heath Service facilities, Israel’s largest HMO.
“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.”
The Petah Tikvah-based company presented its trial results at the Symposium on Advanced Wound Care (SAWC) Spring conference in the US. Results included 68 percent complete closure rates for diabetic foot ulcers and 81% closure for venous ulcers at 24 weeks. Overall, the complete closure rate for all ulcers was about 71% at 12 weeks.
“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.”