FDA gives Athersys green light for AMI drug trial
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 (AMI).
The authorization will allow commencement of the second clinical study for MultiStem, a stem cell product candidate, and its first trial in the cardiovascular disease area, the Cleveland-based Athersys said. MultiStem may have a potential to be used off-the-shelf, according to the company.
Athersys said that 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 AMI. Following standard treatment, enrolled patients will receive MultiStem delivered via a micro-infusion catheter. The patients will then be evaluated and compared to patients receiving standard-of-care only.
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.
The authorization will allow commencement of the second clinical study for MultiStem, a stem cell product candidate, and its first trial in the cardiovascular disease area, the Cleveland-based Athersys said. MultiStem may have a potential to be used off-the-shelf, according to the company.
Athersys said that 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 AMI. Following standard treatment, enrolled patients will receive MultiStem delivered via a micro-infusion catheter. The patients will then be evaluated and compared to patients receiving standard-of-care only.
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.