“We are conducting the phase 2 clinical study at many high volume clinical sites across the U.S., including in California. With respect to the process development work intended to support scaled-up / optimized manufacturing for subsequent phase 3 studies and commercialization, we plan to complete key elements of this work in California, with collaborators such as UC-Davis. We are in the process of building up our California beachhead, and plan that several California-based employees will manage the clinical study, as well as the process development work. Ultimately, success in the phase 2 clinical study and in the process development work would lead to the establishment of a manufacturing plant in California to support later stage development and commercialization in the western half of the U.S. and Asia.”
Wednesday, October 24, 2012
One of the co-founders of Athersys, Inc., of Cleveland, Ohio, is attempting to overturn reviewer rejection of his company's application for an $8.3 million award from the California stem cell agency to assist in a clinical trial for a therapy for stroke victims.
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The application by Robert Mays, who co-founded Athersys in 1995 and is head of neuroscience at the publicly traded firm, was turned down by reviewers who gave it a scientific score of 60 out of 100. Reviewers expressed “concerns related to limited preclinical data, lack of evidence that this therapeutic approach will benefit stroke, and concerns regarding manufacturing within the proposed timeline.”
A document from Mays that CIRM released said reviewers' objections could be addressed by “information that may not have been adequately conveyed at the time or with new information that has since become available.” The document laid out several “recent” studies that it said supported its pitch for funding in a phase two clinical trial.
CIRM's review summary also raised the question of how much of the work would be done in California. The stem cell agency is limited to funding research in California.
May's appeal said,
The Athersys application came in CIRM's first strategic partnership round. Two out of six applications were approved by reviewers. The winners, whose identities are being withheld until tomorrow by the stem cell agency, received scores of 88 and 73. The scores of the other applicants and their identities were also withheld by the agency.
The Athersys appeal will come before the CIRM governing board at its meeting tomorrow in Burlingame, Ca.