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Cell therapy safe, effective in mitigating neuroinflammatory response and preserving brain tissue after TBI
Positive Phase 1 data support ongoing Phase 2 trials in pediatric and adult patients

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New York, NY November 17, 2017 – Cellvation, Inc., a clinical‐stage biopharmaceutical company and majority‐owned subsidiary of Fortress Biotech, Inc. (NASDAQ: FBIO) developing novel cell therapies for the treatment of traumatic brain injury (“TBI”), announced today data demonstrating a patient’s own stem cells may be safe and effective in diminishing neuroinflammatory response and preserving brain tissue in adults following severe TBI. Data from a Phase 1 study of Cellvation’s CEVA101, an autologous bone marrow‐derived mononuclear cell therapy, were published online this month in the journal STEM CELLS.

Researchers at The University of Texas Health Science Center at Houston (UTHealth) conducted the dose‐escalation study in 25 adults with severe TBI and without signs of irreversible brain injury. Bone marrow harvest,  cell  processing  and  re‐infusion  occurred  within  48  hours  after  injury.  The  bone  marrow  mononuclear cells were observed to be safe and well‐tolerated, with no serious adverse events related to the harvest or infusion. Furthermore, investigators in the study found evidence of central nervous system structural preservation, consistent with data from a Phase 1 pediatric trial of Cellvation’s CEVA101, and the mitigation of inflammatory biomarkers following cell infusion.

“The data derived from this trial moves beyond just testing safety of this approach,” said Charles S. Cox, Jr., M.D., principal investigator, the George and Cynthia Mitchell Distinguished Chair in Neurosciences at UTHealth, professor in the Department of Pediatric Surgery and co‐director of the Memorial Hermann Red Duke Trauma Institute. “We now have a hint of a treatment effect that mirrors our pre‐clinical work, and we are  now pursuing  this approach in a Phase 2b  clinical  trial sponsored  by the  Joint Warfighter  Program within the U.S. Army Medical Research Acquisition Activity, as well as our ongoing Phase 2b pediatric severe TBI clinical trial – both using the same autologous cell therapy.”

The Phase 1 study was supported by U.S. Department of Defense grant W81XWH‐11‐1‐0460, National Institutes of Health grant 2T32 GM 0879201‐11, the Glassell Foundation Stem Cell Research Program and The Brown Foundation, Inc. “To our knowledge, the STEM CELLS publication is the first reported clinical assessment of an IV‐infused cell  therapy  for  the  treatment  of  severe  TBI  in  adults.  The  data  set  is  compelling  and  suggests  that  CEVA101 could be a safe and effective approach in the acute trauma setting,” said Frank Taffy, co‐founder, interim CEO, President and a member of Cellvation’s Board of Directors. “We are thrilled to be working with UTHealth to advance this innovative program in a high‐risk setting characterized by significant unmet medical need.”
Charles S. Cox, Jr., M.D., and UTHealth have research‐related financial interests in Fortress, including its subsidiary Cellvation.

About Bone Marrow‐Derived Stem Cells for the Treatment of Traumatic Brain Injury

Traumatic brain injury (“TBI”) remains one of the greatest unsolved problems in clinical trauma care today. Cell‐based  therapy  is  distinguished  from  small  molecule  strategies  by  the  pleiotropic  mechanisms  of  action that have been determined in preclinical data and an excellent safety profile in early clinical trials. The mechanism of action appears to be related to down‐regulation of neuroinflammatory response of the innate immune system. Proof of concept data have been generated by The University of Texas Health Science Center at Houston (UTHealth) using bone marrow mononuclear cells (BMMNCs) in both stroke and  TBI.  These  data  formed  the  foundation  for  Phase  1  and  2  clinical  trials  of  Cellvation’s  BMMNCs  (CEVA101) in pediatric patients with severe TB and in adults with severe TBI. Cellvation also maintains rights to CEVA‐D, a novel bioreactor that amplifies anti‐inflammatory gene programs in adherent bone marrow‐derived mesenchymal stromal cells without external gene transfection approaches. The utility of this approach has been confirmed using in vivo models of TBI. Development of this pipeline of cellular therapeutics represents an opportunity to fundamentally change the approach to TBI treatment.

About The University of Texas Health Science Center at Houston
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education,  innovation,  scientific  discovery  and  excellence  in  patient  care.  The  most  comprehensive  academic health center in The UT System and the U.S. Gulf Coast region, UTHealth is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine  G.  McGovern  Medical  School.  UTHealth  includes The University  of  Texas  Harris  County  Psychiatric Center and a growing network of clinics throughout the region. The university’s primary teaching  hospitals  include Memorial  Hermann‐Texas  Medical  Center, Children’s  Memorial  Hermann  Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit

UTHealth is a leader in cell therapeutics for neurological injury and has developed novel approaches to the  treatment  of  traumatic  brain  injury.  McGovern  Medical  School  at  UTHealth  is  a  collaborator  with  Memorial Hermann‐Texas Medical Center in the Memorial Hermann Red Duke Trauma Institute and Memorial Hermann Mischer Neuroscience Institute. Memorial Hermann‐TMC is one of the busiest Level 1 American College of Surgeons‐verified Adult and Pediatric Trauma Centers in the country.

About Cellvation
Cellvation, Inc., is a clinical‐stage biopharmaceutical company developing novel cellular therapeutics for the  treatment  of  traumatic  brain  injury  (“TBI”).  Cellvation  is  currently  advancing  clinical‐stage  cell  therapies in severe TBI: a Phase 2 study of CEVA101 in pediatric patients ( Identifier: NCT01851083), and a Phase 2 study of CEVA101 in adults ( Identifier: NCT02525432). These studies are supported by grants of approximately $10 million from the National Institutes of Health and the Department of Defense. Cellvation is also developing CEVA‐D, a novel bioreactor that enhances the anti‐inflammatory potency of bone marrow‐derived cells without genetic manipulation. Cellvation is a majority‐owned subsidiary of Fortress Biotech (NASDAQ: FBIO) and is based in New York City.

About Fortress Biotech
Fortress Biotech, Inc.(“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and  commercializing  novel  pharmaceutical  and  biotechnology  products.  Fortress  develops  and  commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. Additionally, Fortress recently acquired a controlling interest in National Holdings Corporation (NASDAQ: NHLD), a diversified independent brokerage company (together with its subsidiaries,  “NHLD”).  In  addition  to  its  internal  development  programs,  Fortress  leverages  its  biopharmaceutical business expertise and drug development capabilities and provides funding and management  services  to  help  the  Fortress  Companies  achieve  their  goals.  Fortress  and  the  Fortress  Companies may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings  to  accelerate  and  provide  additional  funding  to  support  their  research  and  development  programs. For more information, visit

Forward‐Looking Statements
This press release may contain “forward‐looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and  any  other  statements  that  are  not  historical  facts.  Forward‐looking  statements  are  based  on  management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate, and retain key personnel;  the early stage of products  under development; our need for substantial  additional funds;  government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law.


Cellvation, Inc.
Frank Taffy, Co‐Founder, Interim CEO, President, Board Member
(212) 554‐4520

Fortress Biotech Media Relations
Laura Bagby
6 Degrees
(312) 448‐8098