2023-03-22 09:17:44 ET
Athersys ( NASDAQ: ATHX ) said it was making planned amendments to a clinical trial of ischemic stroke therapy MultiStem following a Type B meeting with the U.S. Food & Drug Administration (FDA) on March 21.
The company noted that it had proposed four changes to its ongoing phase 3 study , dubbed MASTERS-2, protocol all of which were accepted by the FDA.
Athersys will change the timing of the main goal assessed by shift analysis in modified Rankin Scale (mRS) score to Day 365 from Day 90 previously.
The company will remove eligibility caps on concomitant reperfusion therapy (such as tPA, MR imaging or tPA+MR imaging) so that the final study population reflects current standard of care in the population eligible for this therapy.
In addition, the company may elect to have an independent statistician carry out an interim analysis to check potential sample size adjustment. The study is currently planned to enroll 300 patients and about 50% enrollment is complete, according to the company.
Athersys added that it retain shift analysis in mRS score at Day 90 as a key secondary goal, along with other revised secondary objectives.
Athersys said the modifications reflect observations seen from a phase 2 trial, dubbed MASTERS-1; a trial called TREASURE carried out by the company's partner in Japan Healios; and evolution of standard of care in treating acute ischemic stroke.
"Although changing the primary endpoint to Day 365 extends the duration of MASTERS-2, we believe our accepted modifications enable accelerated patient enrollment and provide a higher conviction for demonstrating treatment potential," said Athersys CEO Dan Camardo.
MultiStem (invimestrocel) cell therapy is a regenerative medicine being developed which has shown the ability to promote tissue repair and healing, according to the company.
Ischemic stroke happens when the blood supply to part of the brain is interrupted or reduced,
ATHX +8.47% to $1.28 premarket March 22
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Athersys stock rises as FDA accepts changes to phase 3 trial of stroke therapy MultiStem