Stem Cell Therapeutics Receives FDA End of Phase II Meeting Date
08 October 2010 - 11:00PM
Marketwired
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) ("SCT" or the
"Company") wishes to announce that a requested end of Phase II
meeting has been reviewed by FDA and a meeting date has been set
for December 20, 2010.
Dr. Allen Davidoff, Vice President, Product Development of SCT
stated "The Company looks forward to advancing discussions with the
FDA regarding the NTx®-265 programs. We anticipate that the meeting
will focus on a review of the positive safety data generated
to-date in administering NTx®-265, overall analysis of the clinical
efficacy data and the encouraging subgroup analysis of the
REGENESIS-LED trial. Importantly we will be exploring the design
requirements of pivotal trials for NTx®-265 in acute ischemic
stroke."
As stated previously, the Company continues to advance as a
biotech company considering a range of options, with management
focusing its efforts on pursuing the end-of-Phase II meeting with
the FDA for the NTx®-265 stroke therapy, developing a similar
regimen for traumatic brain injury (TBI) while reviewing
alternatives for pursuing multiple sclerosis ("MS") as well as
various other opportunities.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp.
is a 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 amoore@stemcellthera.com Stem Cell
Therapeutics Corp. Angelika Goncalves DaSilva Operations Manager
403-245-5495 ext. 221 adasilva@stemcellthera.com
www.stemcellthera.com
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