15 November 2021 | Monday | News
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Healios noted that following its third quarter 2021 announcement of topline data from its ONE-BRIDGE clinical trial evaluating the safety and efficacy of MultiStem cell therapy in patients with ARDS, it has continued to consult with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding preparations for filing for regulatory approval for MultiStem for the treatment of ARDS. Currently, Healios is targeting the filing of the application for this orphan regenerative medicine product for Q4 2021/Q1 2022.
Healios also provided an update regarding the timing of disclosure of topline data from its double-blind, placebo-controlled TREASURE study to evaluate MultiStem treatment in ischemic stroke patients. As a result of advice from the PMDA, Healios now plans to disclose topline results from the study after data has been collected from the one-year follow-up visit of the last patient enrolled. Healios expects this last follow-up visit to take place in March 2022. Unblinding for data analyses will occur after the collection of information from the last patient follow-up visit.
The update on timing suggests that one-year topline data should be available in the second quarter of 2022. As previously reported, based on results from the MASTERS-1 study for patients who received cell therapy within 36 hours of stroke, recovery outcomes for MultiStem-treated subjects compared to placebo were good at 90 days but even better at one year, including for Excellent Outcome and the mRS “shift” analysis.