Healios Aims for a Novel Cellular Treatment of ARDS

Healios has acquired the right to develop and commercialize the stem cell product MultiStem® (HLCM051), created by Athersys, for domestic use in the treatment of ARDS.

This cellular treatment involves an intravenous administration of HLCM051, within a certain period of time, patients diagnosed with ARDS.

HLCM051, applied intravenously to ARDS patients, accumulates in the lungs and controls excessive inflammation. Furthermore, by protecting damaged tissue and facilitating healing, it is conceivable that it could lead to improvement in lung function. Because of these effects, earlier removal from ventilation and lower mortality rates are anticipated.

Athersys conducted its exploratory clinical study of the intravenous administration of MultiStem cell therapy to treat patients who are suffering from ARDS in the United States and Europe, and announced summary results in January 2019. The study results provide further confirmation of tolerability and a favorable safety profile associated with MultiStem treatment. Importantly, MultiStem treatment was associated with lower mortality and a greater number of ventilator-free and intensive care unit (ICU) free days in the first month following diagnosis relative to patients receiving placebo.

Expected mechanism of action of HLCM051 against ARDS (Produced by Athersys Inc.)

Healios is conducting clinical trials in Japan for patients with pneumonia induced ARDS (trial name: ONE-BRIDGE). The details of the ONE-BRIDGE trial are registered at ClinicalTrials.gov. (Identifier: NCT03807804).