Stem Cell Therapeutics Corp. Announces Enrollment of the First Patient in its REGENESIS Phase IIb Stroke Trial
May 28 2008 - 8:30AM
Marketwired
CALGARY, ALBERTA (TSX VENTURE: SSS) is pleased to announce the
enrollment of the first patient in its REGENESIS Phase IIb stroke
trial. The REGENESIS trial is a double-blind, randomized,
placebo-controlled Phase IIb clinical trial for SCT's lead program,
NTx(TM)-265, for the treatment of acute ischemic stroke. This first
patient was enrolled by the clinical team of Judith Jarrett, Dr.
Gordon Gubitz and Dr. Stephen Phillips at the Queen Elizabeth II
Health Sciences Centre in Halifax, NS. Co-lead investigators for
the REGENESIS Phase IIb trial are Dr. Steven C. Cramer, Principle
Investigator of the BETAS Phase IIa stroke trial, at the University
of California, Irvine; and Dr. Michael Hill at the Foothills
Hospital at the University of Calgary.
As previously announced, the REGENESIS Phase IIb stoke trial
will be a multi-site trial projected to enroll 134 patients at
approximately 18 Canadian sites. A similar U.S. Phase IIb acute
ischemic stroke trial was recently approved by the U.S. Food and
Drug Administration and is projected to enroll 20-30 patients at
3-4 enrolling U.S. sites. The Canadian and U.S. Phase IIb clinical
stroke studies share similar protocols, safety and efficacy
endpoints.
Dr. Allen Davidoff, VP Product Development at SCT, commented as
follows:
"This is an exciting time for the Company as we continue to
advance our lead program in stroke. We hope the REGENESIS Phase IIb
trial will build upon the promising results from the BETAS Phase
IIa trial by demonstrating the positive effect that NTx(TM)-265
exerts on recovery of visual, motor and cognitive recovery in
patients who have suffered moderate to severe acute ischemic
stroke. We anticipate completing enrollment of the REGENESIS study
by the end of 2008."
About NTx(TM)-265: NTx(TM)-265 is a 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 motor, visual and cognitive recovery 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 in SCT's
BETAS Phase IIa 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 REGENESIS Phase IIb stroke study for NTx(TM)-265
with primary endpoints of efficacy. Patient enrollment is expected
to be complete by the end of 2008 with top-line efficacy data
expected to be released before the end of the first quarter of
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.
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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