Stem Cell Therapeutics Corp. Releases Encouraging Clinical Results and Provides Corporate Update
May 21 2009 - 7:30AM
Marketwired
Stem Cell Therapeutics Corp. (TSX VENTURE: SSS) (the "Company" or
"SCT") is pleased to announce that as a result of the U.S. Food and
Drug Administration ("FDA") lifting the Phase IIb clinical hold as
announced on May 15, 2009, and encouraging results from the Phase
IIb patients enrolled prior to the clinical hold, it has decided to
commence the modified Phase IIb REGENESIS clinical stroke trial as
soon as possible, with the goal of completing patient enrollment by
the end of 2009.
Dr. Alan Moore, President and CEO of SCT, commented as
follows:
"Before starting the modified REGENESIS Phase IIb study, we
un-blinded results from the seven patients who were enrolled in the
halted Phase IIb trial. Although these results are not
statistically significant, due to the small number of patients,
they are encouraging and consistent with the Phase IIa results
announced in February of this year. We were also pleased to see
that there were no adverse health effects among the patients who
received the treatment, which is also consistent with our findings
in the Phase IIa trial. All of this has reinforced our confidence
in NTx�-265 and we are excited to proceed with the testing of our
treatment for stroke patients."
The results of the Phase IIb trial from the seven patients
indicated an improvement in the treated group as compared to the
placebo group. This is demonstrated by the graph below; of the
seven patients enrolled, five received placebo and two were treated
with NTx�-265: A decrease in the NIHSS score represents an
improvement in a patient's functionality. A change of 4 units in
the NIHSS scale is considered clinically significant. The placebo
patients score decreased by an average of 1.4 units, which did not
attain this level of clinical significance. The treated patients,
however, showed an average decrease of 9 units, exceeding the level
for clinical significance.
To view a graph of the REGENESIS-Effect of NTx�-265 on NIHSS
Score, please view the following link:
http://media3.marketwire.com/docs/sssgraph0521s.pdf
The Company is also pleased to announce the following corporate
developments:
- Mr. Robert W. Rieder, Chairman and CEO of Cardiome Pharma
Corp. ("Cardiome") has been elected to SCT's Board of Directors.
Mr. Rieder, an MBA, has been Chairman of Cardiome (formerly,
Nortran Pharmaceuticals Inc.) since March 12, 2007 and has been its
Chief Executive Officer since April 16, 1998. Mr. Rieder has
extensive experience in venture capital and in operational
management.
- Dr. W. Dalton Dietrich has joined SCT's Scientific Advisory
Board. Dr. Dietrich is the Kinetic Concepts Distinguished Chair in
Neurosurgery, Professor of Neurological Surgery, Neurology and Cell
Biology and Anatomy, as well as the Scientific Director of the
Miami Project to Cure Paralysis at the Miller School of
Medicine.
Finally, the Company wishes to announce that Dr. Francesco
Bellini of Bellus Health Inc., decided not to stand for re-election
to the SCT's Board of Directors. The Company would like to thank
Dr. Bellini for his contribution while serving on SCT's Board and
to wish him well with his future endeavors.
SCT has issued 100,000 stock options to Mr. Rieder and 25,000
stock options to Dr. Dietrich at an exercise price of C$0.10 per
share in connection with their appointments to the Company. These
options will expire no later than May 20, 2014 subject to
applicable vesting provisions. These options were awarded in
accordance with the Corporations Stock Option Plan.
About REGENESIS: NTx�-265 is SCT's lead therapeutic regimen of
two approved and clinically well-defined drugs, human Chorionic
Gonadotropin ("hCG") and Erythropoietin ("EPO"), targeting the
treatment of stroke. The twin objectives of the treatment are to
stimulate the growth and differentiation of new neurons to replace
the brain cells that were lost or damaged by the stroke, and
importantly, to direct motor, visual, and cognitive recovery after
the acute ischemic stroke. Encouraging clinical results from SCT's
BETAS Phase IIa stroke trial were presented at the International
Stroke Conference in February 2009, showing clinically relevant
recovery in 12 of 12 patients who received the complete
treatment.
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 neurological function lost due to disease or injury. SCT'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 Email: amoore@stemcellthera.com Stem
Cell Therapeutics Corp. Chloe Douglas-Crampton Investor Relations
(403) 245-5495 ext. 221 Email: crampton@stemcellthera.com Website:
www.stemcellthera.com
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