Advertisement
Advertisement
August 9, 2015
FDA Clears Phase-2 Trial for Hemostemix Drug to Treat CLI
August 10, 2015—Hemostemix Inc., a clinical-stage autologous cell-therapy company, announced that the US Food and Drug Administration cleared the company’s Investigational New Drug application for ACP-01. The clearance allows the company to expand its clinical trial to enroll patients at clinical sites across the United States. This is an international phase-2, double-blind, randomized, placebo-controlled clinical trial that is evaluating ACP-10 for the treatment of critical limb ischemia (CLI).
The ongoing phase-2 clinical trial is investigating the safety and efficacy of the company’s ACP-01, which uses angiogenic progenitor cells to combat the life-threatening complications of CLI. These proprietary cells are grown from a patient’s own blood and, once injected into his or her diseased tissue, support the formation of new blood vessels. The trial has enrolled 20 of its targeted 100 patients to date. The phase-2 clinical trial has enrolled patients at six clinical sites in Canada and South Africa, operating under the same protocol.
Advertisement
Advertisement
