September 12, 2016 8:26am
The race has not started; it’s the sign and limber-up period with the pre-market UP +$0.05 or 2.62%
The planned study will be a randomized, double-blind, placebo-controlled clinical trial conducted at hospitals in Japan that have extensive experience at providing care for stroke victims. Based on the experience from the B01-02 study, subjects enrolled in the trial will receive either a single dose of MultiStem or placebo, administered within 18--36 hours of the occurrence of the stroke, in addition to standard of care.
As previously disclosed, the study will evaluate patient recovery through approximately 90 days following initial treatment based on Excellent Outcome and other neurological, functional and clinical endpoints.
The Bottom Line: ATHX completes Japan's Pharmaceutical and Medical Devices Agency review of the Clinical Trial Notification allowing the commencement by HEALIOS of a confirmatory clinical trial evaluating the safety and efficacy of administration of MultiStem
ATHX had closed Friday at $1.91 which was down -0.04 or -2.05%
The pre-market is UP +$0.05 or 2.62%
Additional patient follow up will occur through one year, and other design elements of the Japan trial are consistent with a planned international Phase 3 study, and what has been described previously at the Stroke 2016 conference held in Sapporo earlier this year.
