Stem Cell Therapeutics Corp. Announces Second Positive Review by Data Safety and Monitoring Board for the Modified REGENESIS Pha
January 11 2010 - 8:30AM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:
SSS) announced today it has been advised by the Data Safety
Monitoring Board ("DSMB") that its second regularly scheduled
safety analysis has been completed and the DSMB has recommended for
the Phase IIb acute ischemic stroke trial to continue as per
protocol.
Dr. Alan Moore, President and CEO, commented as follows:
"64 patients have been enrolled to-date in our modified
REGENESIS Phase IIb acute ischemic stroke study. With all of the
planned clinical trial sites in India, Canada and the U.S.
recruiting patients for the Phase IIb acute ischemic stroke trial,
and continuing with the steady patient enrollment rate, we
anticipate Phase IIb patient enrollment to be complete by the end
of Q1 2010 and for top-line data to be available after the 90-day
patient assessment review period is complete, approximately by the
end of Q2 2010. Notably, this remains aligned with the timeline
stated in the announcement of the first positive DSMB review on
November 20, 2009."
In regard to the traumatic brain injury ("TBI") clinical trial,
the Company continues to work with Dr. David Zygun from the
Department of Critical Care at the University of Calgary, Foothills
Medical Centre. The Phase IIa TBI clinical trial is expected to
begin enrolling patients in the first half of this year.
SCT is also working closely with Drs. Luanne Metz and Fiona
Costello of the Multiple Sclerosis Clinic at the Foothills Medical
Centre in Calgary, Alberta to facilitate the advancement of the
multiple sclerosis clinical program.
"2010 is going to be a banner year for SCT," said Dr. Alan
Moore, "and we are working diligently to achieve a number of
important company milestones that should, in turn, translate into
maximized shareholder and corporate value."
About the Data Safety Monitoring Board ("DSMB"): The DSMB is a
group of independent clinical experts that review the ongoing
conduct of a clinical trial to ensure continuing patient safety.
The mandate of SCT's DSMB is to provide objective, independent
monitoring of patient safety during the Phase IIb acute ischemic
stroke trial. This review was the second of three formal meetings
scheduled that will occur over the duration of the Phase IIb stroke
trial.
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.
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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