Athersys Inc. (NSDQ:ATHX) received the regulatory thumbs-up to begin a Phase II clinical trial of its MultiStem stem cell treatment for inflammatory bowel disease.
Development partner Pfizer Inc. will bear the costs for the 126-patient clinical trial, which is expected to begin enrolling patients by the end of the year, Athersys CEO Gil Van Bokkelen said. Last December, Athersys inked a deal with Pfizer to develop and market MultiStem for patients suffering from inflammatory bowel disease.
Separately, Cleveland-based Athersys released its third-quarter results, reporting losses of $3.7 million on revenues of $2 million. That compares with losses of $3.4 million on revenues of $500,000 in last year’s third quarter.
Research and development expenses surged nearly 60 percent, to $4.3 million, due to an increase in spending on clinical and preclinical studies.
MultiStem is an off-the-shelf stem cell treatment derived from bone marrow or other non-embryonic sources. The cells have a drug-like effect, reducing inflammation, protecting damaged tissue and forming new blood vessels, and then are cleared from the body.
Talk of the Pfizer-IBD trial dominated most of a conference call that Athersys executives hosted for analysts and investors Monday afternoon, with most questioners congratulating the company for its progress. The financial markets also responded positively to the news, pushing Athersys’ stock up more than 4 percent Monday to $2.88.
In a rare move, the Food & Drug Administration is allowing Pfizer and Athersys to skip the initial phase of testing and head straight to Phase II. Van Bokkelen attributed the skipped step to the large amount of data the company has generated on testing of MultiStem for a a variety of diseases.
“It’s a signal of confidence, in terms of what we’re doing and how we’re doing it,” he said.
In addition to trials with Pfizer for IBD, Athersys is investigating its stem cell therapy in trials for Graft vs. Host Disease, heart attacks and orthopedics.
