Athersys Receives FDA Agreement Under Special Protocol Assessment for Phase 3 Study of MultiStem® Treatment for Ischemic Stroke

Athersys Receives FDA Agreement Under Special Protocol Assessment for Phase 3 Study of MultiStem® Treatment for Ischemic Stroke

CLEVELAND, Sept. 28, 2016 – Athersys, Inc. (NASDAQ:ATHX) announced today that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of a Phase 3 clinical trial of Athersys’ novel MultiStem® cell therapy product for the treatment of ischemic stroke. The SPA provides agreement from the FDA that the protocol design, clinical endpoints, planned conduct and statistical analyses encompassed in Athersys’ planned Phase 3 study are acceptable to support a regulatory submission for approval of the MultiStem product for treating ischemic stroke patients. The results from the Phase 3 trial entitled, “MultiStem Administration for Stroke Treatment and Enhanced Recovery Study-2” (MASTERS-2), together with other available clinical data, would provide the foundation of the regulatory package to be submitted for marketing approval.

One-Year Results From Phase 2 Stroke Study of MultiStem® Cell Therapy Demonstrate a Significantly Higher Rate of Complete or Nearly Full Recovery

CLEVELAND February 17, 2016 (GLOBE NEWSWIRE) — Athersys, Inc. (Nasdaq:ATHX) today announced positive results from the analysis of one-year follow-up data from its Phase 2 clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who have suffered an ischemic stroke. Dr. David Hess, lead clinical investigator of this study and a stroke specialist and Chairman of the Department of Neurology at the Medical College of Georgia, Augusta University, presented the summary results today at the 2016 International Stroke Conference in Los Angeles. The one-year data demonstrates that MultiStem-treated subjects on average continued to improve through one year and had a significantly higher rate of “Excellent Outcome” (defined clinically as attaining mRS 0-1, NIHSS 0-1 and BI ≥95) compared to placebo subjects at one year when evaluating all subjects enrolled in the study (p=0.02), i.e., the intent-to-treat population. The relative improvement in Excellent Outcomes was even more pronounced in the patients who received MultiStem treatment within 36 hours of the stroke (p < 0.01).

Healios and Athersys Enter Into Regenerative Medicine Partnership for Treatment of Stroke Using MultiStem(R) Therapy

CLEVELAND and TOKYO, Jan. 08, 2016 – Healios K.K. (“Healios”) (Tokyo Stock Exchange:4593) and Athersys, Inc. (“Athersys”) (NASDAQ:ATHX) have announced a partnership and license agreement that will focus on the development and commercialization of novel cell therapy treatments, including MultiStem® for the treatment of ischemic stroke and potentially other indications, in Japan. The partnership involves MultiStem, a proprietary, patented off-the-shelf stem cell therapy being developed by Athersys, with an initial focus on treating ischemic stroke.

Athersys and Chugai Enter License Agreement and Collaboration to Develop MultiStem(R) Cell Therapy for Ischemic Stroke in Japan

Regenerative Medicine Partnership Focused on Development of Novel Stem Cell Therapy
CLEVELAND and TOKYO, March 2, 2015 (GLOBE NEWSWIRE) — Athersys, Inc. (Nasdaq:ATHX) and Chugai Pharmaceutical Co., Ltd. (Tokyo Stock Exchange: 4519) have announced a partnership and license agreement to exclusively develop and commercialize MultiStem® cell therapy for ischemic stroke in Japan. Ischemic stroke represents a priority disease area in Japan, given the high healthcare burden of the condition and the expected increase in incidence associated with Japan’s aging population.

Athersys and Cell Therapy Catapult Announce Grant to Support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory Condition

Innovate UK Grant Awarded for MultiStem(R) Therapy Clinical Trial in United Kingdom
LONDON and CLEVELAND, Jan. 22, 2015 (GLOBE NEWSWIRE) — Athersys Limited (an affiliate of Athersys, Inc.) (Nasdaq:ATHX) and the Cell Therapy Catapult, a not-for-profit centre, which is focused on the development of the United Kingdom cell therapy industry to increase the nation’s health and wealth, are pleased to announce that Athersys Limited has been awarded a grant from Innovate UK, formerly the Technology Strategy Board, which will support a Phase 2a clinical study evaluating the administration of MultiStem® cell therapy to acute respiratory distress syndrome (ARDS) patients.

Athersys Finishes Enrollment of Phase 2 Study of MultiStem(R) Cell Therapy for Ischemic Stroke Top-Line Data Readout Expected Around the End of the First Quarter, 2015

Top-Line Data Readout Expected Around the End of the First Quarter, 2015

CLEVELAND, Dec. 29, 2014 (GLOBE NEWSWIRE) — Athersys, Inc. (Nasdaq:ATHX) today announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys’ MultiStem® cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015.

Stem cell therapy for transplants developed by Athersys Inc. may end need for long-term immunosuppressive drugs

 
CLEVELAND, Ohio (July 23, 2013) — One of the biggest problems facing anyone who receives an organ transplant is rejection. When the immune system, which is designed to keep us healthy, reacts to a donated organ as if it were a foreign invader and attacks, doctors have to prescribe powerful drugs to keep it in check.

Those drugs, called immunosuppressants, are a necessary evil for most transplant recipients for as long as they live. They prevent rejection, but can lead to infection, gastrointestinal disease, pancreatitis, cancer and kidney failure.

Athersys gets OK for German solid organ transplant clinical trial

Stem cell developer Athersys (NASDAQ:ATHX) has received German regulatory clearance for a physician-sponsored solid organ transplant clinical trial.

The study will enroll up to 24 patients and examine Athersys’ MultiStem technology in reducing the likelihood of rejection in patients who’ve undergone liver transplants, CEO Gil Van Bokkelen said in a call to discuss the company’s fourth-quarter earnings.

Enrollment will begin in the second half of the year and Athersys will provide “modest and limited” support, Van Bokkelen said.

Van Bokkelen provided updates on Athersys’ many clinical and preclinical programs with its MultiStem technology, an off-the-shelf stem cell treatment derived from the bone marrow of adults or other nonembryonic sources. The technology has shown promise in reducing inflammation, protecting damaged tissue and forming new blood vessels.

Athersys is investigating MultiStem for several applications, including heart attack, inflammatory bowel disease, stroke, traumatic brain injury and blood diseases.

The company’s most advanced clinical program involves a phase 2 trial in collaboration with Pfizer with inflammatory bowel disease patients. Enrollment in the 126-patient trial is ongoing and expected to be completed at the end of the year. Initial results are expected to be reported in early 2013, Van Bokkelen said.

Athersys gets OK for German solid organ transplant clinical trial

 
March 27, 2012

Stem cell developer Athersys (NASDAQ:ATHX) has received German regulatory clearance for a physician-sponsored solid organ transplant clinical trial.

The study will enroll up to 24 patients and examine Athersys’ MultiStem technology in reducing the likelihood of rejection in patients who’ve undergone liver transplants, CEO Gil Van Bokkelen said in a call to discuss the company’s fourth-quarter earnings.

Enrollment will begin in the second half of the year and Athersys will provide “modest and limited” support, Van Bokkelen said.

Van Bokkelen provided updates on Athersys’ many clinical and preclinical programs with its MultiStem technology, an off-the-shelf stem cell treatment derived from the bone marrow of adults or other nonembryonic sources. The technology has shown promise in reducing inflammation, protecting damaged tissue and forming new blood vessels.

Athersys is investigating MultiStem for several applications, including heart attack, inflammatory bowel disease, stroke, traumatic brain injury and blood diseases.

The company’s most advanced clinical program involves a phase 2 trial in collaboration with Pfizer with inflammatory bowel disease patients. Enrollment in the 126-patient trial is ongoing and expected to be completed at the end of the year. Initial results are expected to be reported in early 2013, Van Bokkelen said.

Stem Cell Therapy Holds Promise for Strokes

Every year, about 700,000 Americans suffer strokes, which occur when a blood vessel in the brain is blocked or bursts.

Stroke is the third leading cause of death in the United States.

Now stroke specialists say stem cells from adult bone marrow may improve patients’ recovery from the condition.

Georgia Health Sciences University is one of several study sites for a stem cell therapy developed by Cleveland-based Athersys. The therapy may reduce the extent of a stroke and enhance recovery even if it is administered more than a day after symptoms begin.

As things stand now, “we have very little to offer patients with moderate to severe strokes after the four-and-one-half-hour treatment window for the clot buster tPA has passed,” says Dr. David C. Hess, a stroke specialist who chairs the Medical College of Georgia Department of Neurology at GHSU.

GHSU researchers have been studying how the stem cells, in animal models, affect ischemic stroke, the most common form of the condition.

“We hope stem cell therapy will help patients get better and get better faster,” Hess says.

Hess speaks to Georgia Health News about the stem cell research and its potential in this video, courtesy of GHSU.