Aastrom Biosciences, Inc., a company who is leading the development of expanded, patient-specific cellular therapies for the treatment of severe cardiovascular disease, announced today that it has completed an important product manufacturing milestone.
The company has transferred its cell cassette manufacturing to ATEK Medical under the strategic partnership that was announced back in October 2010. The single-use cell cassettes are the central component used in Aastrom’s proprietary culturing process at its facility in Ann Arbor, MI.
“As a result of this milestone, which we achieved ahead of schedule, we now have a fully validated and reliable manufacturing partner to support our late stage clinical development programs,” remarked Tim Mayleben, president and CEO of Aastrom. “This will ensure that Aastrom has the inventory of high-quality cell cassettes necessary for the planned mid-2011 start of our Phase 3 clinical program in critical limb ischemia.”
Aastrom also announced today that the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research formally accepted ixmyelocel-T as the non-proprietary name for the company’s investigational cell therapy product. The decision included approval from United States Adopted Names Council as well.
Mr. Maylebeen commented, “We also reached an important product development milestone with the selection of ixmyelocel-T as the generic name of our expanded cell therapy product. This name was reviewed and accepted by the FDA and USAN Council and will be used by us and our collaborators going forward.”