Stem Cell Therapeutics Corp. Provides Corporate Update
27 July 2009 - 10:30PM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:
SSS) announces today an update on key corporate developments and
strategies.
"As announced throughout the past few months, we now have full
regulatory approval to proceed with the modified REGENESIS Phase
IIb stroke trial in the U.S., Canada and India. The Company is in
the process of recruiting patients in these jurisdictions placing
the trial in an excellent position to complete recruitment by the
end of calendar year 2009, and have top-line data available by the
end of Q1 09," stated Dr. Alan Moore, President and CEO. "Our
confidence in the effect of the NTx®-265 regimen on acute ischemic
stroke has been elevated further given the results of a recent
meta-analysis of available clinical data".
SCT conducted a meta-analysis of the combined BETAS Phase IIa
clinical stroke trial data and REGENESIS Phase IIb clinical stroke
trial data. At the time the clinical hold was placed on the
REGENESIS Phase IIb trial, seven patients had been recruited, and
subsequently they completed their 90-day evaluation period. Because
this trial was placebo controlled, patients received either placebo
or NTx®-265 and so could be combined with patient data from the
non-placebo controlled BETAS Phase IIa trial where patients only
received NTx®-265. By performing this type of statistical analysis,
the Company was able to compare the combined data from 19 patients:
14 of which received drug (12 from BETAS Phase IIa and 2 from
REGENESIS Phase IIb) and 5 patients who received placebo (all from
REGENESIS Phase IIb). A decrease in the National Institute of
Health Stroke Score ("NIHSS") represents an improvement in a
patient's functionality, and importantly for a recovering patient,
a decrease of 4 units in the NIHSS scale is considered a clinically
relevant improvement. Of the 5 patients who received placebo, the
average NIHSS actually increased by +0.7 points and out of the 14
patients who received NTx®-265, the NIHSS decreased by 8.1 points.
The p-value from this meta-analysis was greater than 0.0001,
statistically significant.
For both the BETAS Phase IIa trial and REGENESIS Phase IIb
trial, a patient that showed a decrease of 4 NIHSS points or
greater was considered a responder. Hence the meta-analysis, when
expressed as percentage responders, stated that the placebo group
showed a 40% response (2 out of 5) whereas the NTx®-265 treated
group showed a 100% response (14 out of 14) resulting in a p-value
of p greater than 0.01, again statistically significant. The
diagram below summarizes the improvement of patients in both the
placebo group and NTx®-265 treated group.
To view the bar graph associated with this press release, please
visit the following link:
http://media3.marketwire.com/docs/SSS727G.pdf.
"In parallel with re-initiating the Phase IIb stroke trial, we
continue to work on two additional programs, traumatic brain injury
("TBI") and multiple sclerosis ("MS"), both of which should also
reach clinical milestones towards the second half of this calendar
year. We will provide updates on the progress of these efforts as
they reach fruition during the next few months," stated Dr. Alan
Moore, President and CEO. "Concurrently, we are also in discussions
with potential partners for all programs."
As previously announced on July 8, 2009, SCT has offered an
early warrant exercise incentive program (the "Program") designed
to encourage the early exercise of up to 17,250,000 outstanding
share purchase warrants (the "Warrants") for gross proceeds of up
to $2,760,000. The Program is open for a 30 day period which ends
on August 7, 2009. The Program is applicable only to holders of
warrants issued in connection with the Company's financing
completed on November 9, 2007. The warrants have an original
exercise price of $0.50 per Warrant and expire on May 9, 2010.
Holders of Warrants may exercise their Warrants at a temporarily
discounted price of $0.16 per Warrant during the Early Warrant
Exercise Period. Following the early Warrant Exercise Period, the
outstanding Warrants will revert back to being exercisable to
acquire common shares of the Company at a price of $0.50 per
share.
The Company's current cash position is sufficient to complete
all planned milestones including the modified REGENESIS Phase IIb
clinical stroke trial. This is, in part, a result of cost cutting
initiatives that include, but are not limited to, a reduction in
executive salaries (as announced February 9, 2009).
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp.
is a Canadian 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. Chloe Douglas-Crampton Investor Relations
403-245-5495 ext. 221 crampton@stemcellthera.com
www.stemcellthera.com
Sunvest Minerals Corp (TSXV:SSS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Sunvest Minerals Corp (TSXV:SSS)
Historical Stock Chart
From Jul 2023 to Jul 2024