Stem Cell Therapeutics Corp. Receives 'No Objection Letter' From Health Canada for the Phase IIa Clinical Trial in Traumatic Bra
January 28 2010 - 8:30AM
Marketwired
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) ("SCT" or the
"Company") announced today 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") patients . 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 trial.
Dr. Alan Moore, President and CEO, commented as follows:
"We are pleased to receive the go-ahead from Health Canada for
this TBI clinical trial using the same drug regimen as in the
modified REGENESIS Phase IIb acute ischemic stroke study to treat
TBI patients. TBI represents such a huge unmet medical need as
currently there are no marketed products available to treat TBI,
leaving patients with lifelong disabilities. As the therapeutic
regimen for TBI is the same one being used in our Phase IIb acute
ischemic stroke trial, we anticipate this TBI trial to expand our
existing safety database for NTx®-265 as well as efficacy
measures."
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 TBI
patient enrollment in the Phase IIa TBI study at the Calgary
Foothills Medical Centre.
Dr. David Zygun, Principal Investigator, commented as
follows:
"The development of a new therapeutic regimen to treat traumatic
brain injury is urgently warranted. TBI 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 brain injuries both in Canada and
around the world. Using rigorous methodology, we hope to ultimately
translate initial discoveries from the laboratory of Dr. Samuel
Weiss at the University of Calgary into improvements in TBI 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. At
present there are 10 million TBI survivors worldwide, and the
Centers for Disease Control and Prevention estimates that at least
5.3 million Americans are currently living with long-term or
lifelong disabilities related to TBI. A therapy that induces
improved neurological recovery or functional recovery after an
acute injury would increase patient independence, decrease
rehabilitation time and cost, and represent a new important
scientific advancement and medical development.
NTx®-265 for Traumatic Brain Injury: The NTx®-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 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 brain and
nerve 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, multiple sclerosis, Huntington's disease, Alzheimer's
disease, and ALS.
For further information on Stem Cell Therapeutics Corp., visit
www.stemcellthera.com.
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 amoore@stemcellthera.com Stem Cell
Therapeutics Corp. Chloe Douglas-Crampton Investor Relations
403-245-5495 ext. 221 crampton@stemcellthera.com
www.stemcellthera.com
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