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news.Aastrom Biosciences has completed an important product manufacturing milestone with the transfer of cell cassette manufacturing to ATEK Medical under the strategic partnership announced in October 2010.
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The single-use cell cassettes are the central component used in Aastrom’s proprietary culturing process at its cell manufacturing facility in Ann Arbor, Michigan.
In addition, Aastrom’s ixmyelocel-T has been formally accepted by the US Food and Drug Administration’s Center for Biologics Evaluation and Research and the US Adopted Names Council as the non-proprietary name for Aastrom’s investigational cell therapy product.
Aastrom CEO and president Tim Mayleben said the milestone will ensure that Aastrom has the inventory of high-quality cell cassettes necessary for the planned mid-2011 start of the Phase 3 clinical program in critical limb ischemia.
"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," Mayleben said.
Aastrom Biosciences is a developer of patient-specific cellular therapies for use in the treatment of severe, chronic cardiovascular diseases.
The company’s cell-processing technology enables the manufacture of mixed-cell therapies expanded from a patient’s own bone marrow and delivered directly to damaged tissues.
Aastrom has advanced its cell therapies into late-stage clinical development, including a planned Phase 3 clinical program for the treatment of patients with critical limb ischemia and two ongoing Phase 2 clinical trials in patients with dilated cardiomyopathy.