World News: 10:30 GMT Monday 20th March 2017. [Athersys, Inc. via Globe Newswire via SPi World News]
CLEVELAND, March 20, 2017 (GLOBE NEWSWIRE) -- Athersys, Inc. (NASDAQ:ATHX) announced today that clinical investigators have published results from Athersys’ Phase 2 trial of MultiStem cell therapy for treating ischemic stroke patients (the “MASTERS” trial) in the peer-reviewed journal, . The article highlights the feasibility and safety of intravenous MultiStem treatment for patients who have suffered a moderate to severe stroke, the progressive improvements in recovery experienced by these patients through one year, and the increased benefit for those patients receiving MultiStem treatment within 36 hours of their stroke. In addition, the article describes how patients receiving intravenous MultiStem treatment demonstrated a significant reduction in inflammatory cytokines and immune cells and a decrease in infections associated with immunodepression, compared to patients receiving placebo. These trial findings, together with the article below, provide further clarity about important mechanisms of benefit when treating stroke patients with MultiStem – the modulation of the inflammatory response and preservation of immune system homeostasis – promoting accelerated recovery.
“As described in the clinical paper, there were several important observations from the MASTERS study, including evidence that intravenous administration of MultiStem was associated with a substantial increase in the proportion of stroke victims who achieved an Excellent Outcome (defined below) at one year, particularly when treatment occurred within 36 hours of the ischemic event,” commented Dr. David Hess, stroke specialist and Professor & Chairman of the Department of Neurology at the Medical College of Georgia at Augusta University, primary author of the article and lead clinical investigator in the MASTERS trial. “The combination of these observations in conjunction with the clinical safety data and supportive biomarker data from the trial provide a clear basis for moving forward in the MASTERS-2 study.”
This publication coincides with another independent article highlighting additional evidence from preclinical studies of how MultiStem cell therapy provides multiple biological benefits following an ischemic stroke, including data supporting key mechanisms of action. The preclinical research, published in the journal, demonstrates that following a stroke, administration of the cell therapy modulates the inflammatory response initiated by the stroke injury, by down-regulating inflammatory cytokines and immune cells that cause extensive damage in the brain following a stroke or other neurological injury. The publication describes how MultiStem cells minimize this acute inflammatory response by interacting with peripheral immune organs, most notably the spleen. By inhibiting the body’s inflammatory response to the stroke injury and stimulating key reparative mechanisms, MultiStem treatment results in less damage in the brain and promotes more effective recovery.
“A strong foundation of data has been established that illustrates the importance of the spleen and peripheral immune system following an acute neurological injury such as a stroke,” commented Dr. Sean Savitz, Professor of Neurology and Chair of the Department of Neurology at University of Texas, Health Science Center at Houston and McGovern Medical School. “Our preclinical work demonstrates that administration of MultiStem cell therapy has a profound effect on neutralizing the inflammatory-mediated damage that occurs acutely following an ischemic stroke, as well as upregulating reparative pathways, which is consistent with the biomarker data from the MASTERS trial,” concluded Dr. Savitz.
Athersys is planning a Phase 3 study entitled, MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2 (“MASTERS-2”). The MASTERS-2 study has received authorization from the U.S. Food and Drug Administration (“FDA”) under a Special Protocol Assessment (“SPA”) for the design and planned analysis of the pivotal Phase 3 clinical trial. The SPA provides formal agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses in the Phase 3 study are acceptable to support a regulatory submission for marketing approval of MultiStem cell therapy as a product for treating ischemic stroke patients, if the trial is successful. Additionally, the Ministry of Health Labor and Welfare recently provided public notification that the TREASURE Phase 2/3 stroke study being conducted in Japan by Athersys’ partner, HEALIOS K.K., has received a priority review designation, enabling acceleration of the potential assessment time to six months for Japan’s Pharmaceutical and Medical Devices Agency review (under the recently implemented accelerated review pathway for innovative medicines, or ).
The MASTERS-2 clinical trial is a randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to enroll 300 patients at stroke clinical centers in North America and Europe. These patients will have suffered a moderate to severe stroke and will receive either a single intravenous dose of MultiStem cell therapy or placebo, administered within 18-36 hours of the occurrence of the stroke, in addition to the standard of care. The primary endpoint will evaluate disability using modified Rankin Scale (“mRS”) scores at three months, comparing the distribution, or the “shift”, between the MultiStem treatment and placebo groups. The mRS shift analysis considers disability across the full spectrum, enabling recognition of large and small improvements in disability and differences in mortality and other serious outcomes, among strokes of different severities. The study will also assess the defined Excellent Outcome (mRS ≤1, NIHSS ≤1, and Barthel Index ≥95) at three months and one year as key secondary endpoints. Additionally, the study will consider other measures of functional recovery, biomarker data and clinical outcomes, including hospitalization, mortality and life-threatening adverse events and post-stroke complications such as infection.
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Globe Newswire: 10:30 GMT Monday 20th March 2017
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