A Medical Device Daily

Athersys (Cleveland, Ohio) and Angiotech Pharmaceuticals (Vancouver, British Columbia) reported that Athersys has received authorization from the FDA to begin a Phase I clinical trial evaluating the safety of MultiStem, Athersys' non-embryonic stem cell platform technology, in the treatment of acute myocardial infarction (AMI). The companies said they believe this represents the first clinical study of a scalable, allogeneic cell product injected directly into and around the zone of myocardial injury from an intra-coronary approach.

MultiStem cells are proprietary adult stem cells derived from bone marrow, which have the ability to form a range of cell types. A primary mechanism of MultiStem appears to be the production of multiple therapeutic molecules produced in response to inflammation and tissue damage, Athersys said, adding that MultiStem represents a unique "off-the-shelf" stem cell product based on its ability to be used without tissue matching or immunosuppression and its capacity for large-scale production. Based on research conducted by Athersys and its manufacturing partner, Lonza (Visp, Swizerland), the company said that material from a single qualified donor may be used to produce hundreds of thousands or even millions of clinical doses.

Angiotech and Athersys entered into an agreement in 2006 to co-develop and commercialize MultiStem for use in the indications of AMI and peripheral vascular disease. Upon completion of the Phase I trial, Angiotech will assume lead responsibility for further clinical development. Angiotech also owns commercial rights for this product.