Stem Cell Therapeutics Corp. Receives "May Proceed" From FDA for Its Phase IIb Clinical Stroke Trial and IND
April 23 2008 - 10:00AM
Marketwired
CALGARY, ALBERTA (TSX VENTURE: SSS) is pleased to announce that
the U.S. Food and Drug Administration (FDA) has allowed its
investigational new drug application (IND) to proceed. The
IND-opening study is a double-blind, randomized, placebo-controlled
Phase IIb clinical trial of its lead program, NTx(TM)-265, for the
treatment of acute ischemic stroke. The FDA response allows
initiation of the U.S Phase IIb clinical trial in acute ischemic
stroke, led by the Principle Investigator of the Phase IIa 'BETAS'
stroke trial, Dr. Steven C. Cramer, at the University of
California, Irvine. Dr. Cramer is also the co-Lead Investigator of
the Canadian Phase IIb 'REGENESIS' trial along with Dr. Michael
Hill at the Foothills Hospital, University of Calgary.
This U.S. Phase IIb acute ischemic stroke trial is similar to
the previously announced Canadian-based 'REGENESIS' trial. The
recruitment target for this US study is to enroll 20-30 patients at
3-4 enrolling sites. This will accompany the currently enrolling
Canadian Phase IIb 'REGENESIS' stroke trial, projected to enroll
134 patients at approximately 18 sites. The U.S. and Canadian Phase
IIb clinical stroke studies share similar protocols, safety and
efficacy endpoints.
Dr. Alan Moore, President and CEO of SCT commented as
follows:
"We are very excited by the FDA's acceptance of the IND for our
U.S. Phase IIb acute ischemic stroke trial. This acceptance
demonstrates that SCT has met an important clinical development
milestone especially for a non-U.S. biotech company. This U.S.
companion study of the Canadian Phase IIb study is a key component
of the pre-pivotal Phase III program as we aspire to meet worldwide
regulatory acceptance and because the FDA sets a critical
regulatory standard."
Part of the FDA evaluation process included reviewing the
patient safety and efficacy results from the Phase IIa 'BETAS'
clinical stroke trial. Favorable results from the Phase IIa 'BETAS'
stroke trial were released February 20, 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
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 enrolling sites for the multi-centre, double-blind,
placebo-controlled Phase IIb 'REGENESIS' study for NTx(TM)-265 with
primary endpoints of efficacy; enrolment to be complete by the end
of 2008 with top-line efficacy data 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.
SCT's Annual General Meeting will take place on Friday May 16th
at 2:30pm MT at the Sheraton Suites Eau Clare, 255 Barclay Parade
SW, Calgary, Alberta.
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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