11/7/2016 6:51:27 AM
November 7, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Shares of Fortress Biotech, Inc. (formerly known as Coronado Biosciences) are up about 3 percent this morning after the company announced it launched a subsidiary , Cellvation, Inc., to develop therapies for the treatment of traumatic brain injuries (TBI). Coupled with that announcement, Cellvation entered into an agreement with The University of Texas Health Science Center at Houston for worldwide rights to three programs for TBI, including two Phase II cell therapies.
Among the programs, the new company acquired a Phase II study of autologous bone marrow-derived stem cells for the treatment of severe TBI in pediatric patients. Also, Cellvation acquired a Phase II TBI candidate for adults – an autlogous bone marrow-derived stem cells therapy. Both trials are expected to enroll about 50 patients and are supported by a $10 million grant from the National Institutes of Health and the Department of Defense. Cellvation said it will supplement that grant funding in order to open additional clinical sites and accelerate study outcomes.
In addition to the two Phase II candidates, Cellvation also licensed a next-generation bioreactor that enhances the anti-inflammatory potency of bone marrow-derived cells without genetic manipulation from UT Health.
Cellvation said it intends to continue conducting clinical trials here in the United States, but will explore early market entry in Japan under the recently revised Pharmaceutical Affairs Law. Japan’s newly revised law provides for conditional approval of regenerative medicine products upon demonstration of safety and efficacy in early clinical studies, the company said.
According to the Centers for Disease Control and Prevention, TBI is a leading cause of death and disability in adults and children in the United States, contributing to almost one third of all injury-related mortalities.
Lindsay Rosenwald, chairman and chief executive officer of Fortress Biotech, said the company is pleased with its collaboration with UT Health and the potential benefits from the therapies that were developed by Charles Cox, the neurosciences chair at the university.
“TBI is associated with significant unmet medical need and a standard of care that hasn’t evolved much over the past two decades. Data generated by Cox and his team suggest a cell therapy could reduce further injury following a head trauma and improve long-term outcomes,” Rosenwald said in a statement.
Cellvation will be helmed by Frank Taffy, who also serves as CEO of Helocyte, Inc., a company focused on the development of novel immunotherapies for cancer and infectious disease. Taffy previously held the positons of senior director of business affairs at Forest Laboratories (now Allergan) and director of corporate development at Life Technologies (now Thermo Fisher Scientific).
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