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Positive One-Year Data From MultiStem ARDS Study.

CLEVELAND, Ohio, January 14, 2020 -- One-year follow-up summary results from an exploratory clinical study of the intravenous MultiStem cell therapy to treat acute respiratory distress syndrome (ARDS) found "further potential benefits" from the treatment, Athersys, Inc. (NASDAQ: ATHX) announced.

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.

ARDS is a serious immunological and inflammatory condition 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.

ARDS is associated with a high mortality rate and significant sequelae among survivors.

Highlights from the new (and previously disclosed) data include:

* Previously observed lower mortality for Multi-Stem-treated subjects compared to placebo (particularly among the prospec vely 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 prospec vely 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.

"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," said Anthony Ting, vice president of regenerative medicine at Athersys.

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.

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.

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.

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Title Annotation:Clinical TRIALS
Publication:Stem Cell Research News
Geographic Code:4EUUK
Date:Jan 27, 2020
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