CALGARY, AB--(Marketwired - June 18, 2015) - Hemostemix Inc. (“Hemostemix” or the “Company”) (TSX VENTURE: 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.
About Hemostemix
Hemostemix is a public clinical-stage biotechnology company that develops and commercializes innovative blood-derived cell therapies for medical conditions not adequately addressed by current treatments. It is the first clinical-stage biotech company to test a potential breakthrough stem-cell therapy in an international, multicenter, phase-2 clinical trial for patients with critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. The phase-2 trial targets a participant’s diseased tissue with proprietary cells that are grown from his or her blood and capable of supporting the formation of new blood vessels. Hemostemix currently enrolls participants in the phase-2 trial at four sites in South Africa and two sites in Canada.
Hemostemix Inc. is traded on the TSX Venture Exchange under the trading symbol HEM. For more information, visit hemostemix.com or email office@hemostemix.com.
Neither the TSX Venture Exchange, Inc. nor its Regulation Service Provider (as that term is defined under the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
This release may contain forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential,” and similar expressions, or that events or conditions “will,” “would,” “may,” “could,” or “should” occur. Although Hemostemix believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of Hemostemix management on the date such statements were made. Hemostemix expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Help employers find you! Check out all the jobs and post your resume.
