Athersys Inc. (NSDQ:ATHX) has completed patient enrollment in the single-dose portion of a clinical trial that’s treating blood cancer patients with the company’s stem cell therapy.
The Phase 1 study involves dosing patients suffering from leukemia and other blood cancers with Athersys’ MultiStem, an off-the-shelf stem cell treatment derived from the bone marrow of adults or other non-embryonic sources, according to the company. The cells have a drug-like effect, reducing inflammation, protecting damaged tissue and forming new blood vessels, and then are cleared from the body.
The patients involved in the study have received radiation therapy and a stem cell transplant from an outside donor, the company said. Such patients are typically at risk for graft-versus-host disease, which occurs after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient’s body.
The Food & Drug Administration last fall granted MultiStem orphan drug designation by for graft-versus-host disease. 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 clinical trial is a multi-center dose escalation study aimed at evaluating the safety and maximum tolerated dose of MultiStem. The final patient in the single-dose arm was enrolled on Dec. 30. Athersys expects to complete enrollment in the multi-dose arm this year.
Athersys has exclusive development rights for oncology applications of MultiStem. The company has partnered with Pfizer for developing treatments for inflammatory bowel disease and Angiotech for cardiovascular disease treatments.