Athersys (ATHX) Stock Heads Up On Phase II Trial Approval

Athersys ATHX Stock News

Athersys Inc (NASDAQ: ATHX) is heading for the top in the market this morning, and for good reason. The company announced that the FDA has authorized the initiation of a Phas II clinical trial. Here’s what’s happening:

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ATHX Stock Climbs On Phase II Study Approval

In a press release, Althersys said that the United States Food and Drug Administration has authorized its application to initiate a Phase II clinical trial. In the trial, the company will evaluate its MultiStem cell therapy.

In particular, the company is going to be assessing efficacy and safety of the treatment in patients with traumatic injuries and and the subsequent complications associated with severe trauma.

ATHX said that the study will be randomized, double-blind, and placebo controlled. It is expected that about 150 severely injured trauma patients will be enrolled following hospitalization, initial treatment, and admission to the ICU.

Through the study, the patients will be randomized, with one group receiving MultiStem therapy and both groups receiving the current standard of care for their injuries.

Ultimately, the company intends to reduce the occurence of Systemic Inflammatory Response Syndrome, or SIRS. This is a major contributing factor with regard to organ failure and other severe complications in this patient population.

In a statement, Dr. Robert W. Mays, Vice President of Regenerative Medicine at ATHX, had the following to offer:

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. 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. 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.

This Is Big News

While it seems as though investors are only reacting in a big way to COVID-19 related news, the news that came out of Athersys today is huge. The fact of the matter is that trauma is a major cause of death for individuals under the age of 45. In fact, it is the third leading cause of death in the United States.

Not to mention, trauma is also the leading cause of serious disability, especially among young patient populations and members of the millitary. There are about 31 million cases of non-fatal injury rlated to hospitalizations annually.

Should MultiStem therapy prove to be effective, the demand for this treatment could be incredible. As such, this is just another straw in the MultiStem hat, making ATHX an even more interesting investment opportunity.

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