Stem Cell Therapeutics Corp. Receives Positive Review from Data Safety & Monitoring Board
05 September 2008 - 6:54AM
Marketwired
Stem Cell Therapeutics Corp.(TSX VENTURE: SSS) ("SCT") has received
results from the Data Safety Monitoring Board (DSMB) that provides
oversight for the Company's Phase IIb REGENESIS trial. The DSMB has
completed a safety analysis and has recommended the trial continue
as per the protocol.
The REGENESIS Phase IIb clinical trial is designed to
demonstrate that the NTx(TM)-265 therapy is both a safe and
effective therapy capable of improving recovery after acute
ischemic stroke. The mandate of the DSMB is to provide objective,
independent monitoring of patient safety during the REGENESIS
trial. This review was the second of several regularly scheduled
reviews by the four-member DSMB that will occur over the duration
of the trial.
Dr. Alan Moore, President and CEO, commented as follows:
"With the DSMB's decision to proceed, we are pleased to continue
with this pioneering neuro-regenerative trial and we look forward
to increasing enrollment at our Canadian sites through the coming
months."
About REGENESIS: NTx(TM)-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 regimen 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 functional recovery of motor, visual and
cognitive capacity after acute ischemic stroke. Animal studies have
shown a significant recovery in motor function after receiving the
NTx(TM)-265 regimen 24-48 hours post stroke. Encouraging clinical
results from SCT's Phase IIa BETAS stroke trial were presented at
the International Stroke Conference in February 2008, showing
clinically relevant recovery in 8 of 8 patients who received the
complete regimen. SCT is recruiting patients for the multi-centre,
double-blind, placebo-controlled Phase IIb REGENESIS study for
NTx(TM)-265 with primary endpoints of efficacy and safety.
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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