Stem Cell Therapeutics Corp. Receives Green Light to Begin Enrolling Patients in the India Phase IIb Acute Ischemic Stroke Trial
July 21 2009 - 8:30AM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:
SSS) has received a No Objection Letter ("NOL") from the Drug
Controller General of India ("DCGI") to initiate the Phase IIb
acute ischemic stroke trial. This investigational new drug ("IND")
opening study is a double-blind, randomized, placebo-controlled
clinical trial of its lead program, NTx®-265, for the treatment of
acute ischemic stroke. The DCGI response allows initiation of the
modified REGENESIS protocol for the Phase IIb clinical trial in
acute ischemic stroke, which is co-Led by two principle
investigators: Dr. Steven C. Cramer, from the University of
California, Irvine and Dr. Michael D. Hill of Foothills Hospital at
the University of Calgary.
The recruitment target for this study is to enroll 128-130
patients. The Indian, U.S., and Canadian protocols share similar
design, as well as safety and efficacy endpoints.
Dr. Alan Moore, President and CEO, commented as follows:
"Approval from the DCGI to initiate recruitment for the modified
REGENESIS stroke trial in India is an exciting milestone for SCT.
Jurisdictional approvals have now been granted in India, U.S. and
Canada therefore we will begin recruiting patients as soon as
possible."
About the DCGI: Clinical trials are regulated by the Drug
Controller General of India ("DCGI"), who is responsible for
assuring that all clinical trials comply with the requirements of
the International Conference on Harmonization (ICH) of Technical
Requirements for Registration of Pharmaceuticals for Human Use, as
well as Good Clinical Practices. The DCGI approval process
categorizes clinical trials into two types. If the study protocol
has already been approved by a cognizant regulatory authority in
one or more developed countries (such as the U.S., Canada, U.K.,
Switzerland, Germany, Australia, Japan, and South Africa), the
study is classified as a Type A trial and can be approved using a
fast-track process within two to six weeks after the required
documentation has been submitted. All other studies are classified
as Type B. For these, the approval process is generally 8 to 12
weeks. The Institutional Review Board ("IRB") approval process can
be conducted in parallel with the DCGI review and, if import
licenses are needed, the applications for these can also proceed in
parallel. These provisions facilitate the process of getting study
protocols in place and quickly initiating the trials.
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 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®-265 regimen 24-48 hours post stroke. Encouraging final
clinical results from SCT's completed 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 regimen. SCT will soon begin recruiting
patients for the multi-centre, double-blind, placebo-controlled
Phase IIb stroke study for NTx®-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 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.
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 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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