Athersys, the company developing MultiStem (invimestrocel) cell therapy for critical care indications, announced recently that it has been granted a clinical Type B meeting with the US Food and Drug Administration (FDA).
The company was previously granted Regenerative Medicine Advanced Therapy (RMAT) and fast-track designations for the use of MultiStem in the treatment of ischaemic stroke. In the Type B meeting with the FDA, scheduled for late March, Athersys intends to discuss proposed modifications to the ongoing pivotal, Phase 3 MASTERS-2 clinical trial, which is under special protocol assessment (SPA) agreement.
“This is an important step forward as we continue to advance MASTERS-2,” said Manal Morsy, the company’s executive vice president and head of Global Regulatory Affairs. “We are grateful to the FDA for its continued guidance and support for the development of high unmet medical need programmes. We look forward to a collaborative exchange regarding the proposed modifications for the pivotal ischaemic stroke study.”
During the upcoming Type B meeting, Athersys will bring forward proposed modifications to the MASTERS-2 trial, with the intent of establishing primary and secondary outcomes that best reflect the potential benefit of MultiStem treatment in ischaemic stroke patients.
The decision to request this meeting was made following data analysis from the Phase 2 MASTERS-1 trial and the more recent Phase 2/3 TREASURE ischaemic stroke trial, completed by Healios, in Japan—according to an Athersys press release.
Athersys also considered guidance from clinical key opinion leaders on the evolving practices in standard of care for acute ischaemic stroke treatment and engaged expert statisticians to confirm the potential of the proposed protocol amendments.
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, the company claims, including as a potential neuroprotective agent in patients experiencing an ischaemic stroke.