Athersys Provides Update on One-Year ARDS Study Data

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 MultiStemA® 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:

Previously observed lower mortality for MultiStem-treated subjects compared to placebo (particularly among the prospectively defined subset of more severe ARDS patients) persisted out to one-year of follow-up;

Day-365 Quality of Life (QoL) outcomes, assessed by the EQ-5D, were meaningfully better among all survivors who received MultiStem treatment compared to those who received placebo;

Within the prospectively defined group of patients with more severe ARDS, MultiStem treatment was associated with a markedly greater rate of survival and progression to functional independence at one year (i.e., self-care);

As measured at day-28, MultiStem treatment was associated with a higher mean ventilator-free day (VFD) score of 12.9 vs. 9.2 in the placebo group, and a higher mean intensive care unit (ICU)-free day score of 10.3 vs. 8.1 in the placebo group;

As measured at day-28, among more severe ARDS patients, mean VFD in the MultiStem subgroup was 14.6 vs. 8.0 in placebo subgroup. Mean ICU-free days were 11.4 vs. 5.9 for MultiStem and placebo recipients, respectively;

Lower inflammatory cytokine levels at day-7 in the MultiStem group relative to the placebo group, including IFNg, IL-6 and IL-1b among others, suggest the potential for MultiStem treatment to abate the severe inflammatory response associated with ARDS; and

MultiStem treatment was well tolerated in this very sick ARDS patient population, with no serious adverse events related to administration through one year of follow-up.

a??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,a?? noted Dr. Anthony Ting, Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs at Athersys. a??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.a??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.About ARDS
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