FDA Authorizes Initiation of a Phase 2 Trial Evaluating MultiStem® Cell Therapy in Trauma Patients

Maybe, just maybe you would like your hospital to be closely following this even though it is for TBI.  But since your hospital doesn't follow research at all NOTHING WILL HAPPEN. 

FDA Authorizes Initiation of a Phase 2 Trial Evaluating MultiStem® Cell Therapy in Trauma Patients

Athersys, Inc. (NASDAQ: ATHX) announced today that the U.S. Food and Drug Administration (FDA) has authorized an Investigational New Drug (IND) application to initiate a Phase 2 clinical trial evaluating Athersys’ MultiStem^® cell therapy for early treatment of traumatic injuries and the subsequent complications that result following severe trauma. The trial will be conducted by The University of Texas Health Science Center at Houston (UTHealth) at Memorial Hermann-Texas Medical Center in Houston, Texas, one of the busiest Level 1 trauma centers in the United States. The study represents another important application of the company’s MultiStem cell therapy in the critical care area, targeting the severe inflammatory responses associated with poor outcomes.

The objective of the clinical study is to evaluate the safety and effectiveness of MultiStem for the treatment of severely injured patients for the prevention and mitigation of complications that can result following severe traumatic injury. The proposed study will be a randomized, double-blind, placebo-controlled Phase 2 clinical trial estimated to enroll approximately 150 severely injured trauma patients following hospitalization, initial treatment and admission to the intensive care unit. These patients will be randomly assigned to receive MultiStem or placebo and both groups will receive the standard of care for their injuries.

A frequent complication following trauma is the occurrence of Systemic Inflammatory Response Syndrome (SIRS), which can contribute to organ failure or other severe complications. MultiStem has shown promise in reducing the hyperinflammatory response that occurs in a range of situations, by upregulating key reparative mechanisms that may reduce complications and meaningfully improve patient recovery.

"We are appreciative of the FDA’s efforts and their timely feedback on the trauma IND, especially in light of all of the demands on the agency related to the COVID-19 pandemic. We are excited to collaborate with our colleagues at UTHealth and at Memorial Hermann to evaluate the potential for safety and efficacy of MultiStem cell therapy for treating patients that have sustained a severe traumatic injury," stated Dr. Robert W. Mays, Vice President of Regenerative Medicine at Athersys. "Based on results from previous clinical experience evaluating MultiStem in other critical care indications, such as ischemic stroke and acute respiratory distress syndrome, as well as published studies in models of traumatic brain injury, spinal cord injury and other forms of trauma, we believe that the early administration of MultiStem cells can meaningfully mitigate, or lessen, the overt and often detrimental inflammatory cascade that results from the activation of the immune system following occurrence of traumatic injury.

"We believe that the timely administration of our MultiStem cell therapy, regardless of the nature of the acute injury, could lead to fewer complications, quicker recoveries and a better long-term outcome for patients," added Dr. Mays. "The authorization of this study by the FDA is an important step forward that will help us better understand the potential of our technology in this clinical indication."

As previously disclosed, this study is being supported under a grant awarded to McGovern Medical School at UTHealth from the Medical Technology Enterprise Consortium (MTEC). Also, Memorial Hermann Foundation will provide additional funding. The study will be conducted under an Athersys IND, and Athersys will provide the investigational clinical product for the conduct of the trial, as well as regulatory and operational support. The trial protocol authorized by the FDA will be reviewed by the UTHealth Institutional Review Board to provide approval before trial initiation.

According to the Centers for Disease Control (CDC), trauma is the leading cause of death for individuals under the age of 45 and the third leading cause of death in the U.S., accounting for approximately 180,000 fatalities each year. It is also a leading cause of serious disability, especially among young people and members of the military that suffer trauma. According to independent research there are more than 31 million instances of non-fatal injury related hospitalizations annually.¹

¹Zonfrillo, M.R., Spicer, R.S., Lawrence, B.A. et al. Incidence and costs of injuries to children and adults in the United States. Inj. Epidemiol. 5, 37 (2018). https://doi.org/10.1186/s40621-018-0167-6

About MultiStem^®

MultiStem^® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. MultiStem represents a unique "off-the-shelf" stem cell product candidate that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon favorable efficacy data, its novel mechanisms of action, and favorable and consistent tolerability data in clinical studies, we believe that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

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