The trial showed that the company’s MultiStem technology may reduce the incidence and severity of graft-versus-host disease, according to a statement from Cleveland-based Athersys. Graft-versus-host disease (GvHD) often occurs after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient’s body.
Athersys made a similar announcement last May about the interim results of the trial.
The company’s next step in the GvHD application is to meet with regulators to discuss future plans for development, which could include a phase 2/3 trial, according to the statement.
In September 2010, Athersys was granted orphan drug designation by the U.S. Food and Drug Administration for GvHD. The orphan drug designation is important to Athersys because its benefits to the company include funding for certain clinical studies, study-design assistance, tax incentives and seven years of market exclusivity for the product upon regulatory approval, the company said at the time.
Athersys’ MultiStem technology is 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.
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