Print page
Email page
Download PDF
« Previous Release | Next Release »
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.
About Athersys, Inc.
Athersys is a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The company's lead product candidate, ATHX-105, is an oral, selective 5HT2c receptor agonist in Phase I clinical trials for the treatment of obesity. The company is developing other orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE). Athersys is also developing MultiStem(r), a patented, adult-derived "off the shelf" stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation/oncology support, ischemic stroke and other indications.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the possibility of delays in, adverse results of, and excessive costs of the development process; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
This news release was distributed by PrimeNewswire, www.primenewswire.com
SOURCE: Athersys, Inc.
Athersys, Inc.
William (B.J.) Lehmann, J.D., President and
Chief Operating Officer
(216) 431-9900
bjlehmann@athersys.com
In-Site Communications
Lisa M. Wilson
(917) 543-9932
insiteco@ix.netcom.com
(C) Copyright 2007 PrimeNewswire, Inc. All rights reserved.
News Provided by COMTEX