Stem Cell Therapeutics Corp. Announces Completion of Further Analysis of the Modified REGENESIS Stroke Data
September 09 2010 - 10:25AM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:
SSS) wishes to announce that further analyses of the modified
REGENESIS stroke data base have been completed. First, no
dose-related treatment mortality was seen, confirming our earlier
observations. Second, in those patients who received occupational
therapy (OT) - approximately 25% of the total - the NTx®-265
regimen had a statistically significant beneficial effect on the
National Institute of Health Stroke Score ("NIHSS", the defined
primary endpoint in the study), showing a mean reduction of 5.1
points for placebo vs. 8.6 points for NTx®-265 therapy.
Additionally, in this subgroup, the effect of NTx®-265 was also
statistically significant versus placebo on the secondary endpoint
of modified Rankin and trended in favor of NTx®-265 for geriatric
depression score, an important measure of "well being" in
post-stroke patients.
Separately, in an analysis of the approximately 69% of patients
who had one observer throughout the study versus multiple
observers, all endpoints, primary and secondary, were in favor of
the NTx®-265 regimen, although the effects were not as dramatic as
that seen in the OT subgroup, and were not statistically
significant. In the much smaller subgroup that combined criteria,
OT plus a single observer, separation of drug and placebo effect
was even more dramatic for NIHSS. Specifically, the NTx®-265
regimen reduced the NIHSS by a mean of 9.1 points whereas the
placebo mean response was only 3.3 points, and again this
difference was statistically significant.
Dr. Alan Moore, President & CEO of SCT stated "While these
subgroup analyses were not pre-specified, they provide key
information going forward with clinical evaluation of the NTx®-265
regimen, and in discussions with the FDA, on the importance of OT
and one versus multiple assessors. Further, the OT findings appear
to confirm the original mechanistic understanding of the NTx®-265
regimen - that it works by amplifying a natural process, the
restructuring of neural functioning post stroke"
As stated previously, the Company continues to move forward 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 while concurrently
reviewing alternatives for pursuing the traumatic brain injury
("TBI") and multiple sclerosis ("MS") study opportunities, as well
as various external 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.
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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