News & Media
|Hemostemix Prepares Investigational New Drug Application for Review by U.S. Food and Drug Administration for Company’s ACP-01 Formulation to Treat Critical Limb Ischemia|
|Jun 18 2015 -
Hemostemix Inc. ("Hemostemix" or the “Company”) (TSXV: HEM), a clinical-stage autologous cell-therapy company, announced today that it has prepared an Investigational New Drug (IND) application for review by the U.S. Food and Drug Administration (FDA) for the Company’s lead product ACP-01, a potential breakthrough stem-cell therapy for critical limb ischemia (CLI). The time frame for FDA review is approximately 30 days.
“Submitting an IND is the necessary first step in seeking permission from the FDA to initiate clinical trials in the United States,” said Dr. Hardean E. Achneck, Hemostemix vice president of clinical research and operations. “Several hundred patients in different countries have previously been treated with ACP-01, and the clinical results of that activity are supporting our submission.” “The IND submission is the result of excellent teamwork within our Company,” said Dr. Elmar Burchardt, Hemostemix president and CEO. “Subject to FDA clearance of the IND, we are poised to add clinical trial sites in the United States, which would greatly expand participant enrollment in our ongoing phase-2 clinical trial that has active sites in South Africa and Canada, providing significant value to the Company.”
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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