Acorda Therapeutics selected CMC Icos Biologics as contract manufacturer for GGF2, the lead molecule in its neuregulin program. Acorda also has the option to utilize the CMC CHEF1® expression technology, a system that generates production cell lines and provides flexibility to quickly increase manufacturing capacity as needed, notes CMC Icos.
In preclinical studies, neuregulins have demonstrated potential for neurological protection in a number of indications including models of MS and stroke, according to Acorda. Neuregulins have also shown the potential to reduce and even reverse dysfunction in preclinical models of congestive heart failure by directly strengthening and protecting heart muscle cells, the firm adds.
Process development, manufacturing scale-up, and cGMP production will be handled by CMC Icos. Acorda plans to use this supply for continued toxicology studies and early phase clinical trials.
“We anticipate filing an Investigational New Drug application to the U.S. Food and Drug Administration for GGF2 in late 2009 pending results of toxicology studies,” says Andrew R. Blight, Ph.D., CSO of Acorda.