Athersys Craters as Stem Cell Therapy Fails Phase II Stroke Study
April 17, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Athersys, Inc. ' saw its shares plummet 50 percent in early trading Friday, after the company that its stem cell treatment for stroke had failed to beat a placebo in a Phase II trial.
The therapy, dubbed MultiStem, is Atherys’ only candidate and without it, the company is facing almost certain disaster—a development being closely watched by its partner Japanese drugmaker Chugai, which coughed up $10 million up-front payment and $195 million more in milestone and development fees to buy the rights to MultiStem in Japan.
Atherys struggled mightily Friday to find any possible positive stem it could find for the news, after a separate drug failed in an inflammatory bowel disease trial last year. But CEO Gil Van Bokkelen said in a release today that while MultiStem did not reach its objectives, a small subset of 140 patients tested did see an easier recovery.
"While the trial did not achieve the primary or component secondary endpoints, we believe the evidence indicating that patients who received MultiStem treatment early appeared to exhibit meaningfully better recovery is very important and promising," Van Bokkelen said in a statement. "We anticipate additional data and information from the study and will conduct further analyses to generate more insight about the potential for MultiStem treatment in this area."
Atherys had tested the treatment on 140 patients to see if it could stop or reverse the brain damage caused by a stroke. But when measured on the Global Stroke Recovery Assessment scale, the 90-day interim results showed that no significant difference when compared to a placebo.
But Bokkelen said that the 27 out of the 60 patients who received the stem cell treatment saw an easier recovery the earlier in the disease progression they were treated.
Ischemic stroke is caused by a blockage of blood flow to the brain, with 15 million people annually experiencing one, including more than two million people in the United States, Japan and European Union, combined. According to the American Heart Association, ischemic strokes comprise more than 85 percent of all strokes.
Current standard of care for ischemic stroke involves the administration of a thrombolytic (clot dissolving) agent within three to four hours after a stroke has occurred, a narrow window that results in only a small percentage of patients receiving such treatment.
Still, despite the failure, Bokkelen tried his best to tout other programs the company says are ongoing to test MultiStem for other indications.
"We also continue to advance other clinical programs in acute myocardial infarction (AMI) and acute respiratory distress syndrome (ARDS). In AMI, we have previously published promising data from our Phase I study, testing localized delivery of MultiStem shortly following a heart attack, and look forward to completing this Phase II study as soon as possible,” he said. “With respect to ARDS, we are encouraged by the apparent impact in this study on mortality, life threatening adverse events, infection and pulmonary events, which together with our non-clinical study results in pulmonary injury models, suggests the potential for benefit in this patient population.”
“We have a good balance sheet to support this ongoing work and remain confident that our MultiStem therapy and other technologies will have an important impact," added Van Bokkelen.
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