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news.Athersys has received authorization from the FDA to begin a Phase I clinical trial evaluating the safety of MultiStem administration in the treatment of acute myocardial infarction.
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The authorization will allow commencement of the second clinical study for MultiStem, a proprietary stem cell product candidate, its first trial in the cardiovascular disease area. The Phase I study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of single dose administration of allogeneic MultiStem following an acute myocardial infarction (AMI).
Following standard treatment, enrolled patients will receive MultiStem delivered via a micro-infusion catheter. These patients will then be evaluated and compared to patients receiving standard-of-care only.
Athersys has evaluated the safety and ability of MultiStem to improve heart function in multiple animal models, including well-validated preclinical models of AMI. Based on this preclinical work, the company believes that MultiStem may be administered safely and may provide functional benefit to patients suffering severe heart attacks.
Athersys is jointly developing MultiStem for AMI with Angiotech Pharmaceuticals. The partners entered into a collaborative development agreement in 2006 covering the joint development of MultiStem for AMI and certain other cardiovascular indications.
Gil Van Bokkelen, chairman and CEO of Athersys, said: “We believe that MultiStem has the potential to significantly enhance the treatment of heart attacks and other ischemic disorders.”