Athersys (NYSE:ATHX) is looking to Japan for potential opportunities to bring its MultiStem therapies to market quicker.
In its annual financial results call on Thursday, Athersys’ chief operating officer, BJ Lehmann, explained that legislation passed last fall in Japan could allow for conditional approval of new regenerative medicines that demonstrate strong safety profiles in clinical trials, even if efficacy hasn’t been fully demonstrated.
For Athersys, which is in phase 2 studies of a stem cell therapy for stroke, that’s a potentially exciting opportunity, as stroke is the leading cause of death in Japan. Cleveland-based Athersys develops an off-the-shelf biologic product made from adult stem cells that it’s exploring in inflammatory, neurological and cardiovascular diseases.
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Athersys secured some 60 patents last year covering its products in more than two dozen countries, including Japan, and Lehmann said the company is actively exploring opportunities to accelerate development there. “We are currently engaged with Japanese regulators, with possible clinical sites and with potential Japanese development and commercialization partners,” he said.
Meanwhile, it’s continuing a phase 2 clinical trial of its stroke therapy in the U.S. and UK. Enrollment should wrap up by the end of summer, Lehmann said, and initial results are expected later in the year. Athersys developers think MultiStem may be able to protect damaged neurons, reduce inflammation and augment tissue repair if administered up to one or two days after a stroke occurs.
This year, the company also expects to report initial results from a phase 2 clinical trial of MultiStem in patients with ulcerative colitis. It’s collaborating with Pfizer on the study, which completed enrollment late last year after experiencing delays in 2012. Initial results comparing MultiStem to placebo are expected by May.
2014 should also see the launch of two new phase 2 clinical trials of MultiStem in graft-versus-host disease and heart attack. Athersys will also continue collaborating with a group at the University of Regensburg in Germany on a small study of MultiStem in patients undergoing liver transplants.
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Additionally, the Cleveland-based company will continue looking for partners to advance development of small molecule drugs for treatment of obesity or schizophrenia, or both, Lehmann said.
Athersys finished 2013 with $31.9 million in cash and cash equivalents, then added $18.7 million to the balance sheet with a registered direct offering in January. It also re-upped on a deal with Aspire Capital Fund that will allow it to raise $25 million in equity from the fund if necessary.
Revenue was down last year to $2.4 million, from $8.7 million in 2012, and the company posted a net loss of $30.7 million.
[Image credit: Flickr user mmphotograpy]
