Stem Cell Therapeutics Corp. Announces Top-Line Results for the Modified REGENESIS Phase IIb Stroke Trial
May 25 2010 - 7:00AM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:
SSS) announced today the top-line results for the modified
REGENESIS-Phase IIb stroke trial. The modified REGENESIS- Phase IIb
trial, a placebo controlled, double blinded, 3:1 randomized
clinical study, enrolled 96 patients with acute ischemic stroke
between August 2009 and January 24, 2010. SCT reports that the
top-line primary endpoint results for this Phase IIb clinical trial
of NTx®-265 in acute stroke showed that there was substantial
improvement in the primary endpoint absolute change in NIHSS in
both placebo treated patients and those receiving NTx®-265 with no
statistical differences between the groups.
"The profile and magnitude of the placebo response is extremely
surprising and merits further examination" said Dr. Alan Moore, CEO
and President of Stem Cell Therapeutics. "We are currently
conducting a validation review process of the full trial. We expect
to report on the outcome of this within the next 2-3 weeks,
together with results from a number of secondary endpoints such as
modified Rankin and Barthel index, which may provide an alternative
to NIHSS as a pathway forwards."
The results show that NTx®-265 was well tolerated in treated
patients with no adverse affect on mortality. Of the 96 patients
enrolled in the trial, 72 patients were administered a course of
NTx®-265, sequential administration of human chorionic gandotropin
(hCG) followed by erythropoietin (EPO), with the first dose at
24-48 hours after stroke onset while 24 patients were treated with
placebo. All patients were then monitored for 90 days. The top-line
data show that the NTx®-265 treated group showed a drop of 6.3 +/-
0.5 NIHSS compared to placebo drop of 7.3 +/- 0.9 NIHSS. This
difference was not statistically significant. Additionally, none of
the individual dose groups showed a statistically significant
effect compared to placebo.
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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