The study illustrated the potential benefits of MultiStem therapy for treating stroke using standard preclinical models. Researchers observed that intravenous administration of MultiStem one day after a stroke resulted in a substantial reduction in brain tissue loss 28 days post-stroke. The spleen is believed to play a significant role in the body's immune response to the stroke that can result in additional damage following the primary ischemic event. After administration, MultiStem cells limit the inflammatory cascade that results from the initial stroke, thereby reducing the secondary damage that occurs.
"A range of studies show that MultiStem can reduce tissue damage and promoting healing and repair in multiple ways following a stroke, as well as in other acute neurological injuries. This data confirms prior findings and extends our understanding of how MultiStem can work through several distinct and important mechanisms, illustrating how we might be able to have a dramatic impact on outcomes and standard of care for stroke victims," said Dr.
In the preclinical model of stroke used in the study, animals that received treatment with MultiStem versus placebo showed statistically significant increases in the percentage of T regulatory (Treg) cells, which may play an important role in the healing process, and decreases in inflammatory T cells, which are believed to exacerbate damage in the brain following a stroke; a statistically significant reduction in the pro-inflammatory cytokine levels of IL-1β and TNF-α; and a statistically significant increase in levels of the anti-inflammatory cytokine IL-10, also known as human cytokine synthesis inhibitory factor (CSIF). At four days after stroke, animals treated with MultiStem had reduced levels of the serum cytokine IL-6 compared with placebo.
These outcomes support prior research at UTHealth, in which researchers found that animals treated with MultiStem showed normal spleen size and increased levels of anti-inflammatory cytokines in the blood whereas animals treated with placebo showed a reduction in spleen size and an increase in inflammatory cytokines in the blood. Through its multiple pioneering trials and clinical practice, UTHealth has become a leader in developing stem cell therapies for stroke and other neurological disorders that can be translated quickly into patient care.
According to the
MultiStem® cell therapy is a patented product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop cell therapy for use with a bone allograft product in the orthopedic market.
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," "suggest," "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 that could cause actual results to differ materially from those implied by forward-looking statements 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, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of inflammatory bowel disease, acute myocardial infarction, stroke and other disease indications, and the prevention of graft-versus-host disease. 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: our ability to raise additional capital; final results from our MultiStem clinical trials; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials; 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 ability to meet milestones under our collaboration agreements; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; 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.
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