Athersys IND for MultiStem Authorized for Phase I Clinical Trial in Bone Marrow Transplant Support
First IND for Company's Proprietary Stem Cell Product
CLEVELAND, Nov 15, 2007 (PrimeNewswire via COMTEX News Network) -- Athersys, Inc. (OTCBB:AHYS) announced today that it has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug, MultiStem(r), can proceed to a Phase I clinical trial evaluating the safety of MultiStem administration in support of bone marrow transplantation for the treatment of certain cancers of the blood and immune system. This study is the first of several planned clinical trials for MultiStem, which the company believes has broad potential in a number of indications based on its multiple mechanisms of action, its ability to be delivered "off-the-shelf" like a pharmaceutical product, and the safety and effectiveness that have been demonstrated in preclinical studies by the company and its collaborators.
MultiStem cells are proprietary adult stem cells derived from bone marrow, which have the demonstrated ability to form a wide range of cell types. MultiStem may work through several mechanisms, but a primary mechanism appears to be the production of multiple therapeutic molecules produced in response to inflammation and tissue damage. Athersys believes that MultiStem acts as a multi-factor drug delivery system, and represents a unique "off-the-shelf" stem cell product based on its apparent ability to be used without tissue matching or immunosuppression and its capacity for large scale production. Based on research conducted by Athersys and its manufacturing partner, Lonza, the company believes that material from a single qualified donor may be used to produce hundreds of thousand or even millions of clinical doses of MultiStem.
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. There are frequently severe complications associated with such procedures, including infection, damage to tissues with rapidly dividing cells such as in the gastrointestinal tract, and Graft Versus Host Disease, or GVHD, a condition in which transplanted immune cells react against the transplant recipient, that may be life threatening.
Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer of Athersys, commented, "We are excited at the opportunity to begin our first clinical evaluation of the MultiStem platform. Based on our research to date, 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 IND 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."
Athersys has evaluated the safety and efficacy of MultiStem in multiple animal models, including well-validated preclinical models of bone marrow transplantation and GVHD. 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, 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 GVHD. When administered to animals experiencing GVHD, MultiStem-treated animals also displayed a significant increase in survival relative to controls. |
