The University of Texas Health Science Center at Houston (UTHealth)
and Athersys, Inc. (NASDAQ:ATHX) today announced plans to conduct a
Phase 2 clinical trial evaluating Athersys’ MultiStem® cell therapy
for early treatment and prevention of complications after severe
traumatic injury. This first-ever study of a cell therapy for
treatment of a wide range of traumatic injuries will be conducted
at Memorial Hermann-Texas Medical Center, one of the busiest Level
1 trauma centers in the United States.
In conjunction with this planned study, UTHealth
reported that its McGovern Medical School has received a grant
award from the Medical Technology Enterprise Consortium (MTEC) to
support the study. The MTEC grant will provide $2.0 million in
funding and the Memorial Hermann Foundation will provide an
additional $1.5 million. Athersys will provide the investigational
clinical product for the conduct of the trial, as well as
regulatory and operational support, as its contribution to the
trial. Dr. Charles S. Cox Jr., the George and Cynthia Mitchell
Distinguished Chair in Neurosciences in the Department of Pediatric
Surgery and co-Director of the Red Duke Trauma Institute at
Memorial Hermann-Texas Medical Center, will serve as principal
investigator. Co-investigators are Charles Wade, Ph.D. and John B.
Holcomb, M.D. Memorial Hermann-Texas Medical Center is the teaching
hospital of McGovern Medical School.
“Traumatic injury is the leading cause of death
and disability among children and members of the military and also
has a significant impact on the elderly,” commented Dr. Cox.
“Extensive clinical experience indicates that following serious
trauma, an acute hyperinflammatory response is frequently
triggered, resulting in Systemic Inflammatory Response Syndrome, a
condition that can impair recovery and lead to additional
complications. Our prior research demonstrates that administration
of MultiStem following acute neurological injury can help improve
recovery and reduce the occurrence or severity of certain
complications, so we are excited about the clinical potential in
this area.”
The objective of the clinical study, as proposed
by UTHealth in its grant application, is intended to evaluate the
safety and effectiveness of MultiStem for the treatment of severely
injured patients for the prevention and early treatment of
complications after severe traumatic injury. The proposed study is
anticipated to be a randomized, double-blind, placebo-controlled
Phase 2 clinical trial estimated to enroll approximately 150
severely-injured trauma patients within hours of hospitalization
who have survived initial treatment and are admitted to the
intensive care unit. These patients will be randomly assigned to
receive MultiStem or placebo and both groups will receive standard
care for their injuries. The MTEC grant will provide funding for
approximately 50% of the trial cost, with additional funding being
provided by the Memorial Hermann Foundation. Athersys’ support will
include its cost of providing clinical product for the conduct of
the trial and regulatory and operational support. The proposed
Phase 2 clinical trial must still go through review and approval by
the U.S. Food and Drug Administration (FDA), and therefore, the
design is subject to additional input.
“Our preclinical data suggest that
administration of MultiStem following injury mitigates the
inflammatory cascade that ensues after traumatic injury that causes
considerable damage to end organs, such as the lungs and kidneys,”
said Dr. Robert Mays, Vice President of Athersys and Head of the
company’s neuroscience programs. “We and the team at UTHealth also
believe MultiStem has the potential to respond to signals of
inflammation and tissue damage in various ways, including
protection of injured cells, stimulation of new blood vessels, and
the recruitment of other cell types to promote tissue repair and
healing, as well as the reduction of complications following the
initial injury.”
“Now that the formal grant award has been
awarded, we will continue our preparations with UTHealth to
finalize the design and planning for the study and will
subsequently present that information to the FDA and other relevant
regulators for their review, consideration and input,” concluded
Dr. Mays.
According to the Centers for Disease Control
(CDC), trauma is the leading cause of death for individuals under
the age of 45 and the third leading cause of death in the U.S.,
accounting for approximately 180,000 fatalities each year. It is
also a leading cause of serious disability, especially among young
people that suffer trauma and members of the military. The CDC
reports that, in the most recent year evaluated, 2013, there were
more than 2.5 million emergency department visits for traumatic
brain injury (TBI) and more than 282,000 hospitalizations. Over 5
million people in the U.S. are living with a TBI-related
disability, and an estimated 80,000 – 90,000 people suffer a
serious disability from TBI each year in the U.S. at an estimated
cost of $37.8 billion, annually.Source:
https://www.cdc.gov/traumaticbraininjury/get_the_facts.html
Seventy-five percent of trauma-related deaths
occur during the first three days after injury and are primarily
due to uncontrolled bleeding and TBI. After three days, the
remaining twenty-five percent of deaths occur at a low, but steady,
rate and result from inflammation or immune complications, blood
vessel damage, and poor clotting associated with the initial
injury, shock and resuscitation. These inflammatory-related
complications include acute kidney injury, acute respiratory
distress syndrome, venous thromboembolic disease, multiple organ
failure, neurological swelling and tissue death after TBI, as well
as secondary infections.
About MTEC
MTEC is a biomedical technology consortium
collaborating with multiple government agencies under an agreement
with the U.S. Army Medical and Materiel Command. The MTEC mission
is to assist the Army’s Medical Research and Materiel Command by
providing cutting-edge technologies and effective materiel life
cycle management to transition medical solutions to industry.
About UTHealth
Established in 1972 by The University of Texas
System Board of Regents, The University of Texas Health Science
Center at Houston (UTHealth) 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 is home to schools of biomedical informatics,
biomedical sciences, dentistry, nursing and public health and the
John P. and Kathrine G. McGovern Medical School. UTHealth includes
The University of Texas Harris County Psychiatric Center, as well
as the growing clinical practices UT Physicians, 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 MultiStem
MultiStem cell therapy is a patented
regenerative medicine product that has shown the ability to promote
tissue repair and healing in a variety of ways, such as through the
production of therapeutic factors produced 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 product 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 safety profile
demonstrated in both preclinical and clinical settings, MultiStem
therapy could provide a meaningful benefit to patients, including
those suffering from serious diseases and conditions with unmet
medical need. Athersys has forged strategic partnerships and a
broad network of collaborations to develop MultiStem cell therapy
for a variety of indications, with an initial focus in the
neurological, cardiovascular and inflammatory and immune disorder
areas.
About Athersys
Athersys is an international 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,
cardiovascular, and inflammatory and immune disease areas, 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 the MultiStem cell therapy toward
commercialization. More information is available at
www.athersys.com.
Forward-Looking StatementsThis
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 regulatory approval and market acceptance of
our product candidates and our ability to generate revenues,
including MultiStem for the treatment of traumatic injury, ischemic
stroke, acute myocardial infarction, spinal cord injury, trauma and
acute respiratory distress syndrome and other disease indications,
including 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: the success of
our collaboration with Healios and others, including our ability to
reach milestones and receive milestone payments, and whether any
products are successfully developed and sold so that we earn
royalty payments; our possible inability to realize commercially
valuable discoveries in our collaborations with pharmaceutical and
other biotechnology companies; our collaborators' ability to
continue to fulfill their obligations under the terms of our
collaboration agreements; the success of our efforts to enter into
new strategic partnerships or collaborations and advance our
programs; our ability to raise additional capital; results from our
MultiStem clinical trials, including the Phase 2 clinical trial for
early treatment and prevention of complications after severe
traumatic injury, the MASTERS-2 Phase 3 clinical trial and the
TREASURE trial in Japan; the possibility of delays in, adverse
results of, and excessive costs of the development process; our
ability to successfully initiate and complete clinical trials
within the expected time frame or at all; 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 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.
ATHX-SCI
Contact:William (B.J.) LehmannPresident and
Chief Operating OfficerTel: (216)
431-9900bjlehmann@athersys.com
Karen Hunady Corporate Communications and Investor RelationsTel:
(216) 431-9900khunady@athersys.com
David SchullRusso Partners, LLCTel: (212) 845-4271 or (858)
717-2310David.schull@russopartersllc.com
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