Cell Therapy Development Advances in Hemorrhagic Trauma, Acute Ischemic Stroke

Clinical development is progressing for Athersys’ cell therapy MultiStem (invimestrocel), with enrollment having completed in the second cohort of the MATRICS-1 clinical trial (NCT04533464) in hemorrhagic trauma and enrollment having reached the halfway mark in the MASTERS-2 trial (NCT03545607) in ischemic stroke.

“We are pleased to report these enrollment updates as they demonstrate both increasing interest in MultiStem and improved execution by our team and our partners. We’ve been able to significantly accelerate patient enrollment in MASTERS-2 due to more effective site management, enhanced clinician confidence based on TREASURE results and the opening of more sites. Athersys’ enthusiasm about MultiStem for the treatment of ischemic stroke has been bolstered by results from completed clinical trials, and we look forward to providing updates on MASTERS-2 after we engage with regulatory authorities during the first quarter of 2023,” Dan Camardo, chief executive officer, Athersys, said in a statement, also noting results from Athersys’ partner Healios’ phase 2/3 TREASURE study of MultiStem for ischemic stroke conducted in Japan.

TREASURE, along with the previous MASTERS-1 trial (NCT01436487), has produced data supporting an increased recovery benefit in patients with acute ischemic stroke treated with MultiStem.

The phase 1/2, double-blind, randomized, placebo-controlled MATRICS-1 investigator-initiated study is underway at the University of Texas-Houston and the Memorial Hermann Hospital and is partly supported by Medical Technology Enterprise Consortium in partnership with the Department of Defense. The second cohort was dosed with cells manufactured under Athersys’ new 3D manufacturing process and data will be compared against patients treated with 2D-manufactured cells in the first cohort. The trial plans to enroll 156 participants total with enrollment of the third and final cohort expected to begin later in 2023.

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“Cell therapy is among the most promising treatment paradigms for neurological and other disorders. MultiStem’s unique mechanism may shift the treatment of stroke by expressing a range of therapeutically relevant proteins and other factors to deliver multiple clinical benefits, including reducing inflammation, protecting damaged or injured tissue, and enhancing the formation of new blood vessels in regions of ischemic injury. By considering the effects of secondary immune modulation, therapeutic benefit may be better observed over longer periods of time versus current commercial treatments like tPA,” Sean I. Savitz, MD, director, World Stroke Organization and Frank M. Yatsu, MD, chair, neurology, McGovern Medical School, UTHealth Houston, added to the statement.

The phase 3, double-blind, randomized, placebo-controlled MASTERS-2 company-sponsored trial is underway at multiple, international centers, with more sites expected to be activated throughout 2023. The trial has now enrolled over half of the 300 expected participants.

“Clinical results to date – including those from TREASURE and MASTERS-1 – demonstrate success that meets or even exceeds the efficacy that tPA delivers to stroke patients after 90 days when administered within approximately 30 minutes of the ischemic event. I believe that MultiStem holds potential to be a significant advancement in the treatment of stroke with longer-term patient benefits by providing a solution as impactful as tPA while significantly extending the treatment window. In fact, I see strong parallels between tPA treatment results in the 1990s and MultiStem today,” David Chiu, MD, FAHA, professor, Elizabeth Blanton Wareing Chair in the Eddy Scurlock Stroke Center, Houston Methodist Hospital, Weill Cornell Medical College, added to the statement.

Chiu, along with other key opinion leaders were part of a November 2022 meeting convened by Athersys that discussed potential changes to the MASTERS-2 trial design. The company is considering adjusting protocols to de-risk the program based off data from the previous clinical trials. Any possible changes would be subject to regulatory agency submission and approval.

“Following productive discussions during our recent meeting with stroke KOLs, the totality of data from MASTERS-1 and TREASURE gives us confidence that MultiStem progressively improves patient outcomes, with emerging evidence of meaningful benefit 365 days post-treatment. We intend to share these data with the FDA and EMA later this quarter to evaluate the design of the MASTERS-2 trial and ensure it supports this hypothesis,” Willie Mays, PhD, Executive Vice President and Head, Regenerative Medicine and Neuroscience Programs, Athersys, added.

REFERENCE

Athersys provides MultiStem clinical update. News release. Athersys. January 9, 2023. https://www.businesswire.com/news/home/20230109005293/en/Athersys-Provides-MultiStem-Clinical-Update