Athersys
A biopharmaceutical company developing therapeutic products for the treatment of diseases.
All edits by Jordan Cannan
Cleveland biotechnology company Athersys Inc has received Fast Track designation from the U.S. Food and Drug Administration in acute respiratory distress syndrome, or ARDS.
The designation comes in the wake of what the company in a news release characterized as "favorable top-line results from a randomized, double-blind placebo-controlled exploratory Phase 2 clinical study" in January evaluating MultiStem administration to patients with ARDS.
In what Athersys calls the "MUST-ARDS study," patients who received MultiStem treatment within several days after being diagnosed with ARDS and being placed on a ventilator "experienced lower mortality, increased ventilator-free days, and increased ICU-free days during the initial 28-day clinical assessment period relative to patients receiving placebo," according to the release.
Athersys' partner in Japan, Healios K.K., has initiated and is enrolling patients in a clinical trial evaluating administration of MultiStem to pneumonia-induced ARDS patients in Japan.
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