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news.Israel-based biotechnology firm Macrocure has completed patient enrollment in its double-blind, Phase III clinical trial of CureXcell to treat diabetic foot ulcers (DFUs).
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CureXcell is a combination of living human white blood cells that have been activated to facilitate the healing process and stimulate wound closure.
A total of 280 patients at 25 sites have been enrolled and randomized in the Phase III trial.
Currently, CureXcell is being evaluated in two Phase III clinical trials to treat chronic, hard-to-heal wounds below the knee.
The first trial is a multicenter, randomized, double-blind, parallel group, sham-controlled study of CureXcell in DFUs and its results are expected to be reported in the second half of 2015.
The company’s second Phase III clinical trial is evaluating CureXcell in Venous Leg Ulcers (VLUs) and interim data from the study is expected in the second half of 2015 with the trial scheduled to conclude in the second half of 2016.
Macrocure president and chief executive officer Nissim Mashiach said the rate at which the company was able to enroll patients in the DFU trial allowed them to meet its previously disclosed milestone.
"We are eager to extend our resources, with the same level of focus, to the VLU trial," Mashiach said.
"If successful, the DFU clinical trial will be one of two pivotal trials to support our Biologics License Application for CureXcell, which we believe has the potential to change how chronic, hard-to-heal wounds are treated."