Stem Cell Therapeutics Receives Clearance from Health Canada to Proceed with the Phase IIb Clinical Stroke Trial
20 July 2009 - 10:48PM
Marketwired
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS)("SCT" or "the
Company") has received a No Objection Letter ("NOL") from Health
Canada for the modified REGENESIS protocol using NTx�-265 for a
Phase IIb clinical trial treating acute ischemic stroke.
Dr. Alan Moore, President and CEO, commented as follows:
"We are pleased that Health Canada has issued an NOL for the
modified REGENESIS clinical trial. This welcome development means
that we are able to proceed with recruitment of patients, testing
the NTx�-265 regimen in patients with acute ischemic stroke in
Canada again and demonstrating the ability of this novel approach
to speed recovery from stroke disabilities. This satisfying
development can be directly attributed to the perseverance and
strong belief of all the SCT staff that NTx�-265 will, in the
future, redefine the therapies available to patients recovering
from acute ischemic stroke, traumatic brain injury, and
neurological disease."
About REGENESIS (a Phase II prospective, randomized,
double-blind, placebo controlled study of NTx�-265: hCG and epoetin
alfa in acute ischemic stroke patients): NTx�-265 is SCT's lead
therapeutic regimen of two approved and clinically well-defined
drugs, human Chorionic Gonadotropin ("hCG") and Erythropoietin
("EPO"), targeting the treatment of stroke. The twin objectives of
the treatment are to stimulate the growth and differentiation of
new neurons to replace the brain cells that were lost or damaged by
the stroke, and importantly, to direct motor, visual, and cognitive
recovery after the acute ischemic stroke. Encouraging clinical
results from SCT's BETAS Phase IIa stroke trial were presented at
the International Stroke Conference in February 2009, showing
clinically relevant recovery in 12 of 12 patients who received the
complete treatment. SCT received clearance from the FDA to proceed
with the Phase IIb stroke trial on May 15, 2009.
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.
For further information on Stem Cell Therapeutics Corp., visit
www.stemcellthera.com.
These securities have not been registered under the United
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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.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts 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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