Hemostemix Receives FDA Clearance for Phase-2 Clinical Trial of Lead Product ACP-01 in the United StatesAugust 10, 2015
Hemostemix Inc. (“Hemostemix” or the “Company”) (TSXV: HEM), a clinical-stage autologous cell-therapy company, announced that the Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to expand its trial for critical limb ischemia (CLI) to enroll patients at clinical sites across the United States. This is a key milestone in its international phase-2 double-blind, randomized, placebo-controlled clinical trial.
The ongoing phase-2 clinical trial investigates the safety and efficacy of the company’s lead product, 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, are able to support the formation of new blood vessels. The trial has enrolled 20 of its target 100 participants to date.
“The FDA’s favorable review of our IND application within the minimum statutory 30-day review period attests to the strength of our clinical trial design,” said Dr. Hardean E. Achneck, vice president of clinical research and operations at Hemostemix. “Our clinical trial is designed to rigorously evaluate our lead product, ACP-01, with high statistical power in 100 patients. Meeting the enrollment target of 100 patients is even more feasible now that Hemostemix has received FDA clearance of its IND application, which enables us to open additional clinical trial sites in the U.S. The phase-2 clinical trial has already experienced robust enrollment in large part because the existing six clinical sites in Canada and South Africa operate under the same protocol.”
“Together with the strong recruitment that we see from our existing trial sites, FDA clearance demonstrates that Hemostemix can expedite the development of ACP-01 for treating CLI patients in the U.S. and other major markets,” said Dr. Elmar Burchardt, president and CEO of Hemostemix. “This key milestone demonstrates our ability to meet the highest standards of the most important regulatory agencies in the world.”
About Critical Limb Ischemia (CLI)
CLI is a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. About half of CLI patients either die or require amputation of the affected limb within one year of diagnosis. Demand for a treatment is on the rise, as CLI predominately affects the growing population aged 50 and older.
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