Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine company developing MultiStem® (invimestrocel) cell therapy for critical care indications, announces patient enrollment has begun in the third and final cohort in MATRICS-1, the Phase 2 clinical study evaluating MultiStem® in patients following resuscitation from hemorrhagic trauma. This study is being conducted at The University of Texas Health Science Center at Houston (UTHealth Houston) and Memorial Hermann-Texas Medical Center, a leading certified Level One Trauma Center, and approximately 140 patients will be enrolled in cohort three. MATRICS-1 is supported in part by MTEC (Medical Technology Enterprise Consortium) in partnership with the Department of Defense, and funding from Memorial Hermann Foundation.
Patients in the third cohort will be dosed with MultiStem cells produced under Athersys’ novel 3D bioreactor-based manufacturing process, a process that was first utilized to produce product for patients in cohort two of MATRICS-1. MultiStem is believed to deliver benefit for treating complications due to trauma through mechanisms including reducing inflammatory damage, protecting at-risk tissue at the site of injury and upregulating reparative aspects of the local and systemic immune system in a more timely way.
“We’re excited to move forward and initiate cohort 3 of this important trial with our partners at UTHealth Houston, Hermann-Texas Medical Center and DoD/MTEC based on a positive DSMB review. MultiStem’s unique mechanism of action has the potential to address the often fatal complications that occur following a severe traumatic event. The final cohort will utilize clinical product manufactured using a 3D bioreactor process and all doses are readily available through our contract manufacturer,” said Dan Camardo, Chief Executive Officer of Athersys.
“When administered soon after a traumatic injury, MultiStem holds potential to reduce the inflammatory cascade and mitigate secondary tissue damage. With the third cohort now being enrolled, I’m pleased we have entered the final stretch of our important research to try to improve trauma outcomes,” said Dr. Charles S. Cox Jr., the George and Cynthia Mitchell Distinguished Chair in Neurosciences and the Glassell Family Distinguished Chair in the Department of Pediatric Surgery with McGovern Medical School at UTHealth Houston, who is Principal Investigator of the study at the Memorial Hermann-Texas Medical Center site.
The MATRICS-1 double-blind, placebo-controlled Phase 2 study is evaluating the safety and effectiveness of MultiStem for the prevention and early treatment of complications after severe traumatic injury. The study is enrolling severely injured trauma patients who have survived initial treatment and are admitted to the intensive care unit, where they are randomized to receive MultiStem or placebo within hours of hospitalization, along with standard of care.
MultiStem® (invimestrocel) cell therapy is a patented regenerative medicine product in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy’s potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The therapy 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. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent tolerability demonstrated in clinical studies, we believe that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.
About UTHealth Houston
Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth Houston) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth Houston is home to Jane and Robert Cizik School of Nursing, John P. and Kathrine G. McGovern Medical School, D. Bradley McWilliams School of Biomedical Informatics, and schools of biomedical sciences, dentistry, and public health. UTHealth Houston includes the UTHealth Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UTHealth Neurosciences, UT Dentists, and UT Health Services. The university’s primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children’s Memorial Hermann Hospital, and Harris Health Lyndon B. Johnson Hospital. For more information, visit www.uth.edu.
About Memorial Hermann Health System
Charting a better future. A future that’s built upon the HEALTH of our community. This is the driving force for Memorial Hermann, redefining health care for the individuals and many diverse populations we serve. Our 6,700 affiliated physicians and 32,000 employees practice the highest standards of safe, evidence-based, quality care to provide a personalized and outcome-oriented experience across our more than 260 care delivery sites. As one of the largest not-for-profit health systems in Southeast Texas, Memorial Hermann has an award-winning and nationally acclaimed Accountable Care Organization, 17* hospitals and numerous specialty programs and services conveniently located throughout the Greater Houston area. Memorial Hermann-Texas Medical Center is one of the nation's busiest Level I trauma centers and serves as the primary teaching hospital for McGovern Medical School at UTHealth. For more than 115 years, our focus has been the best interest of our community, contributing nearly $500 million annually through school-based health centers and other community benefit programs. Now and for generations to come, the health of our community will be at the center of what we do – charting a better future for all.
*Memorial Hermann Health System owns and operates 14 hospitals and has joint ventures with three other hospital facilities, including Memorial Hermann Surgical Hospital First Colony, Memorial Hermann Surgical Hospital Kingwood and Memorial Hermann Rehabilitation Hospital-Katy.
Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for disease indications in the neurological, inflammatory and immune, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance MultiStem cell therapy toward commercialization. Investors and others should note that we may post information about the Company on our website at www.athersys.com and/or on our accounts on Twitter, Facebook, LinkedIn or other social media platforms. It is possible that the postings could include information deemed to be material information. Therefore, we encourage investors, the media and others interested in the Company to review the information we post on our website at www.athersys.com and on our social media accounts. Follow Athersys on Twitter at www.twitter.com/athersys. Information that we may post about the Company on our website and/or on our accounts on Twitter, Facebook, LinkedIn or other social media platforms may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. You should not place undue reliance on forward-looking statements contained on our website and/or on our accounts on Twitter, Facebook, LinkedIn or other social media platforms, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
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. In addition, 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 risk that we will be unable to raise capital to fund our operations in the near term and long term, including our ability to obtain funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, on terms acceptable to us or at all, and to continue as a going concern and our ability to successfully resolve the payment issues with our primary contract manufacturer and gain access to our clinical product. The following risks and uncertainties 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: our ability to raise capital to fund our operations in the near term and long term, including our ability to obtain funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, on terms acceptable to us or at all, and to continue as a going concern; our ability to successfully license our SIFU technology; our collaborators’ ability and willingness to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the possibility of unfavorable results from ongoing and additional clinical trials involving MultiStem; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in an early stage clinical trial may not be predictive of results in later stage or large scale clinical trials; our ability to regain compliance with the Nasdaq continued listing requirements; the timing and nature of results from MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial evaluating the administration of MultiStem for the treatment of ischemic stroke; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; the success of our MACOVIA clinical trial evaluating the administration of MultiStem for the treatment of ARDS induced by COVID-19 and other pathogens, and the MATRICS-1 clinical trial being conducted with The University of Texas Health Science Center at Houston evaluating the treatment of patients with serious traumatic injuries; the availability of product sufficient to meet our clinical needs and potential commercial demand following any approval; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints, contamination, operational restrictions due to COVID-19 or other public health emergencies, labor constraints, regulatory issues or other factors that could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for neurological, inflammatory and immune, cardiovascular and other critical care indications; changes in external market factors; changes in our industry’s overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; the success of our efforts to enter into new strategic partnerships and advance our programs; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; the success of our competitors and the emergence of new competitors; and the risks mentioned elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2021 under Item 1A, “Risk Factors” and our other lings with the SEC. You should not place undue reliance on forward-looking statements, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.