Stem Cell Therapeutics Corp. Receives 'No Objection Letter' From Health Canada for Its Traumatic Brain Injury Trial
16 September 2008 - 6:13AM
Marketwired
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) ("SCT") is pleased
to announce it has received a No Objection Letter (NOL) from Health
Canada for the Company supported, investigator led Phase IIa single
centre, open label study to characterize the safety of human
Chorionic Gonadotropin (hCG) & Erythropoietin (EPO) in severe
traumatic brain injury (TBI). Dr. David Zygun, MD, MSc, FRCPC,
Assistant Professor in the Departments of Critical Care Medicine,
Clinical Neurosciences and Community Health Sciences, University of
Calgary, Foothills Medical Centre, Calgary Health Region, will be
the Principal Investigator for this Phase IIa TBI study.
Dr. Alan Moore, President and CEO, commented as follows:
"TBI represents a logical expansion of our therapeutic and
clinical program scope. The therapeutic need in this area is
extremely high as there are no marketed products approved for the
treatment of TBI. The Phase IIa TBI therapeutic regimen is the same
treatment being used in the Phase IIb REGENESIS stroke program thus
we anticipate a supportive and expanding safety database in
addition to endpoint measures of activity and efficacy."
The protocol of the Phase IIa TBI study has been reviewed by
Health Canada. Approval by the University of Calgary's Office of
Medical Bioethics is pending and once received will permit
immediate enrollment at the Calgary Foothills Medical Centre.
Dr. David Zygun, Phase IIa TBI study Principal Investigator,
Foothills Medical Centre, commented as follows:
"Traumatic injury is the most important cause of preventable
morbidity and mortality in North America. Traumatic brain injury is
common and is the single most important injury contributing to
traumatic mortality and morbidity. Severe traumatic brain injury
comprises only 10% of all brain injuries, but contributes the
greatest proportion of deaths, disability, and cost related to
traumatic brain injury both in Canada and around the world. Thus,
the development of new a therapeutic regimen is urgently warranted.
Utilizing rigorous methodology, we hope to ultimately translate
initial discoveries from the laboratory of Dr. Samuel Weiss at the
University of Calgary into improvements in patient outcomes. This
initial safety assessment is an essential component of the process
that will lead to larger efficacy trials."
About Traumatic Brain Injury: Traumatic injury to the head
resulting from automobile accidents, concussive explosions or
serious athletic impact to the head represents serious events that
cause loss of independence and demand intense medical intervention
with recovery periods that often persist for months or years. A
therapy that induces improved neurological recovery or functional
recovery after an acute injury would increase patient independence,
decrease rehabilitation time and cost, represent a new important
scientific advancement and medical development.
NTx(TM)-265 for Traumatic Brain Injury: The NTx(TM)-265 regimen
is similar to that used in the REGENESIS Phase IIb stroke program.
The objectives of the regimen are to stimulate the growth and
differentiation of new neurons to replace the brain cells that were
lost or damaged by the severe brain injury, and importantly, to
direct functional recovery of motor, visual and cognitive
capacity.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp.
is a Canadian public biotechnology company (TSX VENTURE: SSS)
focused on the development and commercialization of drug-based
therapies to treat central nervous system diseases. SCT is a leader
in the development of therapies that utilize drugs to stimulate a
patient's own resident stem cells. The Company's programs aim to
repair neurological function lost due to disease or injury. The
Company's extensive patent portfolio of owned and licensed
intellectual property supports the potential expansion into future
clinical programs in numerous neurological diseases such as
traumatic brain injury and multiple sclerosis.
These securities have not been registered under the United
States Securities Act of 1933, as amended, or the securities laws
of any state, and may not be offered or sold within the United
States or to, or for the account or benefit of U.S. persons unless
an applicable exemption from U.S. registration requirements is
available.
Except for historical information, this press release may
contain forward-looking statements, which reflect the Company's
current expectation regarding future events. These forward-looking
statements involve risk and uncertainties, which may cause but are
not limited to, changing market conditions, the successful and
timely completion of clinical studies, the establishment of
corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the
regulatory approval process and other risks detailed from time to
time in the Company's ongoing quarterly and annual reporting.
The TSX Venture Exchange does not accept responsibility for the
adequacy or accuracy of this release.
Contacts: Stem Cell Therapeutics Corp. Alan Moore, PhD President
and CEO (403) 245-5495 ext.224 Email: amoore@stemcellthera.com Stem
Cell Therapeutics Corp. Chloe Douglas-Crampton Investor Relations
(403) 245-5495 ext. 221 Email: crampton@stemcellthera.com Website:
www.stemcellthera.com
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