The Phase I study will be an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of single or multiple dose administration of allogeneic MultiStem in patients with acute leukemia, chronic myeloid leukemia, or myelodysplasia. Patients will receive treatment with MultiStem following a bone marrow transplant conditioning regimen and hematopoietic stem cell transplantation.
MultiStem has been shown to be non-immunogenic, even when administered without the genetic matching that is typically required for conventional bone marrow or stem cell transplantation. Furthermore, Athersys says that in animal model systems testing immune reactivity of T-cells against unrelated donor tissue, MultiStem has been shown to suppress the undesired T-cell-mediated immune responses that are an important factor in causing graft versus host disease (GVHD). When administered to animals experiencing GVHD, MultiStem-treated animals also displayed a significant increase in survival relative to controls.
Gil Van Bokkelen, chairman and CEO of Athersys, said: “We believe that MultiStem may provide key benefits over current standards of care in the bone marrow transplantation area, as well as other areas such as heart attack, stroke and other ischemic neurological disorders. With this investigational new drug authorization, we now plan to initiate the Phase I trial for use of MultiStem in bone marrow transplant support as soon as possible after receiving clearance from the institutional review boards of clinical institutions participating in this trial.”