Athersys shares plunge 65% after stem cell treatment for stroke fails clinical trials
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Athersys shares plunge 65% after stem cell treatment for stroke fails clinical trials
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Athersys shares plunge 65% after stem cell treatment for stroke fails clinical trials.
On May 20, 2022, Athersys announced that its stem cell therapy for stroke failed to meet the primary endpoint of a Phase 2/3 trial, and the company’s stock price plummeted more than 65% at the open today, with a current market value of only $67 million.
Athersys is an established stem cell company founded in 1995 and listed on the Nasdaq in 2007, Athersys aims to develop novel therapies that prolong and improve the quality of human life, especially in the field of regenerative medicine.
Athersys is developing MultiStem® , a patented, “off the shelf” stem cell therapy platform derived from adult bone marrow for disease indications in the areas of nervous system, inflammation and immunity, and cardiovascular disease, as well as other critical care indications .
MultiStem promotes tissue repair and healing in a number of ways and has previously received FDA Fast Track and Regenerative Medicine Advanced Therapy designations.
The clinical trial, conducted in Japan, is a randomized, double-blind Phase 2/3 clinical trial that enrolled 206 patients, with a mean age of 78 years, who had experienced moderate or moderately severe ischemic stroke.
Randomized to receive MultiStem stem cell therapy or placebo within 18-36 hours .
Results of the trial showed that after receiving a single dose of MultiStem stem cells, patients did not show a statistically significant improvement within 90 days, and the clinical trial missed its primary endpoint.
Athersys said the patients in this clinical trial were older and therefore recovered more slowly and less robustly. In another ongoing clinical trial of stem cells for the treatment of stroke, the average age of the participants is much younger and the likelihood of success is high.
Athersy ‘s also said that while the clinical trial fell short of its primary focus at 90 days, the function of essentially all tests continued to improve for a year over time, and the quality of life of the treated patients continued to improve.
Athersy ‘s R&D pipeline
Athersy ‘s R&D pipeline is divided into three major directions: Neurology , Inflammation and Immunity , and Cardiovascular Disease .
The research and development pipeline in the direction of neurology includes: ischemic stroke, hemorrhagic stroke, traumatic brain injury, multiple sclerosis, and spinal cord injury.
Among them, ischemic stroke has entered clinical phase 3, and the rest are in preclinical stage.
The research and development pipeline in the direction of validation and immunity includes: graft-versus-host disease (GvHD) brought about by hematopoietic stem cell transplantation , acute respiratory distress syndrome, trauma, and solid organ transplantation support.
The R&D pipeline of cardiovascular diseases includes: acute myocardial infarction, PVD/PAD/CLI, congestive heart failure.
References :
https://www.athersys.com/home/default.aspx
Athersys shares plunge 65% after stem cell treatment for stroke fails clinical trials
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