Athersys Provides Update on One-Year ARDS Study Data

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CLEVELAND, Jan. 14, 2020 (GLOBE NEWSWIRE) -- Athersys, Inc. (NASDAQ: ATHX) announced today the one-year follow-up summary results from its exploratory clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who are suffering from acute respiratory distress syndrome (ARDS). Participants in the MUST-ARDS study were evaluated through 28 days for the primary clinical assessment and further assessed through a one-year follow-up period. The one-year results were consistent with the positive day-28 results announced last year, and an evaluation of quality-of-life over the one-year period suggests further potential benefits from MultiStem treatment.

Highlights from the new and previously disclosed data include:

“We believe that the more favorable outcomes, as reflected in the patient reported self-assessments, particularly among patients recovering from more severe ARDS, suggest that administration of MultiStem has the potential to meaningfully enhance the ability of these patients to reestablish functional independence and restore quality of life,” noted Dr. Anthony Ting, Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs at Athersys. “Frequently, ARDS patients have a very challenging road to recovery, suffering depression or decreased physical abilities. Many are unable to return to work or engage in other activities. The prospect of being able to help many patients overcome these difficulties is very exciting, and we look forward to publishing these results.”

The MUST-ARDS study was designed to evaluate the impact of MultiStem treatment in subjects with acute onset of moderate to severe ARDS and was conducted at sites in the United States and United Kingdom. Treatment was required to begin within four days of ARDS diagnosis with an average treatment time of approximately two days from the diagnosis. In the Phase 2a portion of the study, 20 subjects were treated with an intravenous administration of 900 million MultiStem cells and 10 subjects received placebo; the study was not powered for the efficacy outcomes. Based on the study results, the Company is planning further development in this area and intends to submit for publication the detailed study data.

ARDS is a serious immunological and inflammatory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, trauma or other events and represents a major cause of morbidity and mortality in the critical care setting. ARDS is associated with a high mortality rate and significant sequelae among survivors. The condition prolongs ICU and hospital stays and often requires extended convalescence in the hospital and rehabilitation care settings. There are limited interventions and no effective drug treatments for ARDS. There is a large unmet need for a safe treatment that can reduced mortality and improve quality of life for those suffering with ARDS. Additionally, given the high treatment costs associated with ARDS, a successful therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU.

MultiStem® cell therapy is a patented regenerative medicine product 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 distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The therapy represents a unique "off-the-shelf" stem cell product 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 its efficacy profile, its novel mechanisms of action, and a favorable and consistent safety profile demonstrated in clinical studies, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at . Follow Athersys on Twitter at .

William (B.J.) LehmannPresident and Chief Operating Officer Tel: (216) 431-9900

Karen Hunady Director of Corporate Communications & Investor RelationsTel: (216) 431-9900

David SchullRusso Partners, LLCTel: (212) 845-4271 or (858) 717-2310


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Globe Newswire: 11:00 GMT Tuesday 14th January 2020

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