Athersys Inc. (NASDAQ: ATHX) has received the regulatory thumbs-up to begin a Phase 2 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 Inc. to develop and market MultiStem for patients suffering from inflammatory bowel disease (IBD).
Separately, the Cleveland-based company released its third-quarter financial data, showing that it lost $3.7 million on revenues of $2 million. That compares with a loss 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.
Though you wouldn’t guess this from its financials, there’s plenty of activity at Athersys with the company’s MultiStem product candidate. 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 U.S. Food and Drug Administration is allowing Pfizer and Athersys to skip the initial phase of testing and head straight to Phase 2. 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“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.
