Athersys has reported positive results from a trial evaluating MultiStem cell therapy for the treatment of patients with acute respiratory distress syndrome (ARDS).
Initial data from the double-blind, randomised, placebo-controlled portion of the trial demonstrated that 25% of patients treated with MultiStem achieved lower mortality rate than the 40% of patients treated with placebo.
It was also found that patients in the MultiStem treatment group achieved higher ventilator-free (VF) days and ICU-free days compared to the patients in the placebo group.
The trial also showed that MultiStem was well tolerated in very sick ARDS patients, with no serious adverse events related to the therapy.
Evaluation of biomarker data showed lower levels of inflammatory markers / cytokines following MultiStem treatment.
Patients were studied for 28 days for the study’s primary clinical assessment. They are expected to undergo further analysis during a one-year follow-up period.
Athersys chairman and CEO Dr Gil Van Bokkelen said: “We believe this exploratory study met all of its key objectives and view it as an important indication of the potential relevance of MultiStem in another critical care area where there is substantial unmet medical need.
“The consistent pattern of results suggesting a beneficial effect on mortality and key clinical parameters provides us with confidence that this is another condition where administration of MultiStem can have a meaningful therapeutic impact.”
The ARDS trial was designed to investigate the impact of MultiStem and was conducted at sites in the US and UK.
It comprised a small initial dose confirmation phase followed by a larger double-blinded, placebo-controlled and randomised stage called Phase IIa.
The first phase saw six subjects receive MultiStem. In Phase IIa, 20 subjects were treated with an intravenous (IV) administration of 900ml of MultiStem cells, while ten participants received IV placebo.