Fortress Biotech said today it has formed a subsidiary that will carry out three programs to develop new therapies for traumatic brain injury (TBI) under an exclusive license from The University of Texas Health Science Center at Houston (UTHealth).

Two of the three programs will entail Phase II trials for an autologous bone marrow-derived stem cell therapy for severe TBI. One trial is an ongoing randomized, multicenter, double-blind, placebo-controlled study of the therapy set to enroll up to 50 pediatric patients ages 5–17. The other is a randomized, double-blind, placebo-controlled trial set to start in up to 55 adults ages 18–55.

The Phase II studies are being funded by approximately $10 million in grants from the NIH and Department of Defense, Fortress said.

Cellvation’s research will build on proof-of-concept data using bone marrow mononuclear cells in both stroke and TBI—data that has formed the foundation for translation into Phase I and II clinical trials at UTHealth. The mechanism of action appears to be related to downregulation of neuroinflammatory response of the innate immune system.

Also licensed by Cellvation were rights from UTHealth to a next-generation bioreactor designed to enhance the anti-inflammatory potency of bone marrow-derived cells without genetic manipulation.

In addition to pursuing clinical development of its lead programs in the U.S., Cellvation will also explore early market entry in Japan under that nation’s recently revised Pharmaceutical Affairs Law, Fortress said. The law provides for conditional approval of regenerative medicine products upon demonstration of safety and efficacy in early clinical studies.

Cellvation programs were developed by Charles S. Cox Jr., M.D., director, Children’s Regenerative Medicine, McGovern Medical School at the UTHealth Department of Pediatric Surgery, who will serve as a key scientific advisor to the company. Dr. Cox is also co-director of the Memorial Hermann Red Duke Trauma Institute and is the George & Cynthia Mitchell distinguished chair in neurosciences.

“Cellular therapies are a highly promising strategy to mitigate the neuroinflammatory response to TBI that amplifies the initial injury,” Dr. Cox said in a statement. “Targeting this ‘secondary brain injury’ is designed to preserve injured tissue and ultimately improve outcomes.”

Fortress said Frank Taffy will serve as Cellvation’s interim CEO, president, and a board member. Taffy now serves as president, CEO, and a board member of Helocyte, a company he also co-founded that is focused on developing novel immunotherapies for cancer and infectious disease.

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