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news.Canadian biotechnology firm Hemostemix has prepared an investigational new drug (IND) application for its lead product, ACP-01, a potential breakthrough stem-cell therapy for critical limb ischemia (CLI), a severe form of peripheral artery disease (PAD).
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The company said that the time frame for FDA review is about 30 days.
CLI is caused by reduced blood flow to the legs and about half of CLI patients either die or require amputation of the affected limb within one year of diagnosis.
Hemostemix clinical research and operations vice-president Dr Hardean Achneck said: "Submitting an IND is the necessary first step in seeking permission from the FDA to initiate clinical trials in the US.
"Several hundred patients in different countries have previously been treated with ACP-01, and the clinical results of that activity are supporting our submission."
CLI predominately affects the growing population aged 50 and older, with demand for a treatment on the rise.
Hemostemix president and CEO Dr Elmar Burchardt said: "Subject to FDA clearance of the IND, we are poised to add clinical trial sites in the US, which would greatly expand participant enrollment in our ongoing phase-II clinical trial that has active sites in South Africa and Canada, providing significant value to the company."
Hemostemix is focused on developing and commercializing new blood-derived cell therapies for medical conditions not adequately addressed by current treatments.