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FDA Issues Fast-Track Designation For Multistem Program For ARDS.

CLEVELAND, Ohio, May 14, 2019 -- Athersys, Inc. (NASDAQ: ATHX) announced that its clinical program evaluating MultiStem cell therapy for the treatment of acute respiratory distress syndrome (ARDS) has been fast-tracked by the FDA.

Fast track designation allows for an expedited regulatory review process after the clinical data is submitted to help speed development of promising therapies to the market in order to help patients in areas where current standard of care is limited.

In January 2019, the company announced favorable top-line results from a randomized, doubleblind placebo-controlled exploratory Phase 2 clinical study evaluating MultiStem administration to patients with ARDS, referred to as the MUST-ARDS study.

ARDS is a serious life-threatening pulmonary condition that requires patients to be placed on a ventilator in the intensive care unit and is associated with a high level of mortality.

Many patients who survive face extended stays in the ICU and experience difficult and challenging recoveries.

In the MUST-ARDS study, patients who received MultiStem treatment within several days after being diagnosed with ARDS and being placed on a ventilator experienced lower mortality, increased ventilator-free days, and increased ICU-free days during the initial 28-day clinical assessment period relative to patients receiving placebo.

Additional data from the trial was presented on May 20 at the annual American Thoracic Society meeting.

The company's collaborator in Japan, HEALIOS K.K., is enrolling patients in its clinical trial evaluating administration of MultiStem to pneumonia-induced ARDS patients in Japan.

ARDS is characterized by widespread inflammation in the lungs. It can be triggered by pneumonia, sepsis, trauma or other events and represents a major cause of morbidity and mortality in the critical care setting.

It prolongs ICU and hospital stays and requires convalescence in the hospital and rehabilitation. There are limited interventions and no effective drug treatments for ARDS, making it an area of high unmet clinical need with high treatment costs.

MultiStem cell therapy has been shown to reduce inflammation, support tissue regeneration and promote homeostasis in acute immunological and injury settings. Preclinical data suggests that MultiStem cells may have a protective effect by shifting the physiological response from pro-inflammatory to antiinflammatory, and through the promotion of key reparative mechanisms.

Contact (fast track process):


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Title Annotation:Enforcement & Regulation
Publication:Stem Cell Research News
Geographic Code:4EUUK
Date:Jun 3, 2019
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