Stem Cell Therapeutics Corp. Confirms Receipt of FDA Minutes
March 18 2011 - 1:29PM
Marketwired
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) ("SSS" or "Stem
Cell Therapeutics") is pleased to announce that it has received the
minutes from the FDA meeting of December 20, 2010. The purpose of
that meeting was to present data from the NTx®-265 Phase I and
Phase II studies to obtain medical, safety and statistical input
about a planned pivotal study design.
Management is encouraged that the FDA minutes confirm their
understanding of the discussions during the meeting.
Management is currently reviewing the minutes and incorporating
them into the ongoing planning and design of another NTx®-265
trial. The next steps for this pivotal trial will include
finalizing the protocol, planning the execution of the trial,
determining appropriate financing and evaluating feasibility.
Further details about the planned trial will be announced once they
are available.
This news release shall not constitute an offer to sell nor the
solicitation of an offer to buy nor shall there be any sale of
these securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of any such
jurisdiction.
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 stroke,
traumatic brain injury, multiple sclerosis, Huntington's disease,
Alzheimer's disease, and ALS.
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. Allen Davidoff, PhD CSO
403-245-5495 ext.226 adavidoff@stemcellthera.com Stem Cell
Therapeutics Corp. Michael Cook CFO 403-245-5495 ext. 229
mcook@stemcellthera.com Stem Cell Therapeutics Corp. Angelika
Goncalves DaSilva Operations Manager 403-245-5495 ext. 230
adasilva@stemcellthera.com www.stemcellthera.com
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