Stem Cell Therapeutics Corp. Receives Formal Clearance From the FDA to Proceed With Their Phase IIb Stroke Trial
May 15 2009 - 8:00AM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or "the Company") (TSX VENTURE:
SSS) is pleased to announce the U.S. Food and Drug Administration
("FDA") has now issued a formal letter to the Company confirming
immediate removal of the clinical hold placed on the Phase IIb
stroke trial, September 18, 2008. This permits re-initiation of
clinical studies for NTx�-265.
Dr. Alan Moore, President and CEO, commented as follows:
"We are very pleased that the FDA has followed up their verbal
confirmation so quickly with a formal letter to lift the clinical
hold, allowing us to initiate the Phase IIb clinical trial with
limited delay."
About REGENESIS: 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.
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 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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