Stem Cell Therapeutics Corp. Announces Second Quarter 2008 Financial Results

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Wed Aug 27, 2008 6:18pm EDT

  CALGARY, ALBERTA, Aug 27 (MARKET WIRE) -- 
Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE: SSS) today announced
its financial results for the period ended June 30, 2008.

    Selected Highlights

    During the second quarter of 2008 and up to August 27, 2008, SCT achieved
the following accomplishments:

    - On April 23, 2008, SCT announced that the U.S. Food and Drug
Administration has allowed its investigational new drug application (IND)
to proceed. The IND-opening study is a U.S. double-blind, randomized,
placebo-controlled Phase IIb clinical trial of its lead program,
NTx(TM)-265, for the treatment of acute ischemic stroke. The FDA response
allows initiation of the U.S. Phase IIb clinical trial in acute ischemic
stroke, led by the Principle Investigator of the Phase IIa BETAS stroke
trial, Dr. Steven C. Cramer, at the University of California, Irvine. Dr.
Cramer is also the co-Lead Investigator of the Canadian Phase IIb
REGENESIS trial along with Dr. Michael Hill at the Foothills Hospital,
University of Calgary. We anticipate patient enrollment for the U.S.
Phase IIb stroke study to begin in Q4 08 and to be complete in Q2 09.

    - On May 28, 2008, SCT announced the enrollment of the first patient in
its REGENESIS Phase IIb stroke trial. The REGENESIS trial is a
double-blind, randomized, placebo-controlled Phase IIb clinical trial for
SCT's lead program, NTx(TM)-265, for the treatment of acute ischemic
stroke.

    - On May 30, 2008, the Company announced the appointment of Thomas R.
Franck to the Executive Team as Vice President of Commercial Planning.
Mr. Franck is a 30-year veteran of Procter & Gamble and has extensive
experience and skill as a sales and marketing director. His current focus
on development projects will play a key role with SCT's pre-Phase III
planning. Mr. Franck's knowledge will assist in managing our pre-launch
professional relations as well as establish the valuation both of
individual programs and the Company as a whole.

    - On July 7, 2008, SCT announced the issuance of two keystone prolactin
patents. The U.S. patent, numbered 7,393,830 and entitled "Prolactin
induced increase in neural stem cell numbers" was issued July 1, 2008.
The Australian patent, numbered 2002325711 and entitled "Prolactin
induced increase in neural stem cell numbers and therapeutical use
thereof" was issued January 10, 2008. These are the first patents to
issue in this patent family. These patents cover the use of prolactin
alone, as well as in combination with other therapeutics that augment
recovery and therefore provide a broad base of protection. We have the
exclusive right to the use of prolactin for treating neurodegenerative
diseases and therefore have a strong foundation to develop many possible
products using prolactin, either as a single therapeutic or in
combination with other neurogenic agents.

    - On July 28 2008, SCT announced the presentation of data from the phase
I open labeled uncontrolled pharmacokinetic study of a single
intra-muscular hCG dose in healthy male volunteers at the IX World
Conference on Clinical Pharmacology and Therapeutics in Quebec City,
Quebec. This study demonstrated for the first time that administering hCG
systemically in man resulted in appreciable amounts of hCG in the central
nervous system and established that drug would be present and available
to signal neurogenesis during the time of an acute neurological injury.
Additionally, two forms of hCG were compared, Pregnyl(TM) derived from
human urine and Ovitrelle(TM) a recombinant form. These two forms of hCG
demonstrated similar pharmacokinetics when administered peripherally,
both in blood and cerebrospinal fluid.

    Dr. Alan Moore, President and CEO, commented on the Phase IIb acute
ischemic stroke trial as follows:

    "We were very pleased to begin recruiting patients for the REGENESIS
Phase IIb stroke trial in May of this year; however site initiation and
patient enrollment have been slower to date than anticipated. As a result
we are looking to do a portion of the trial in India. If we are
successful in this regard then we may be able to meet our milestone of
completing enrolment in the Phase IIb clinical stroke trial by the end of
this year."

    Upcoming 2008 Milestones

    - Complete enrollment in the REGENESIS Phase IIb clinical stroke study
for NTx(TM)-265

    - Initiate and enroll patients in the Phase IIa clinical study for
Traumatic Brain Injury

    - Initiate and enroll patients in the U.S. IND approved Phase IIb
clinical stroke study for NTx(TM)-265

    - Complete animal efficacy studies for Multiple Sclerosis

    Capital Position

    As of June 30, 2008 the working capital (current assets minus current
liabilities) of the Company was $6,515,537 ($9,138,263 as of December 31,
2007).

    Outstanding securities as of June 30, 2008 and August 26, 2008 totaled
103,529,864 common shares, 6,000,000 class B shares, 25,912,500 common
share purchase warrants and 7,930,556 common share options.

    Financial Review

    The Company's loss for the six month period ended June 30, 2008 increased
by $802,835 to $2,892,025 ($0.03 per common share) from the loss of
$2,089,190 ($0.03 per common share) reported for the six month period
ended June 30, 2007. The primary reason for the change in the reported
loss figure is the increase in research and development costs. The June
30, 2008 "Management Discussion and Analysis" provides further details on
these operating results.

    About NTx(TM)-265: NTx(TM)-265 is a 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 regimen 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 acute ischemic stroke. Animal studies have shown a
significant recovery in motor function after receiving the NTx(TM)-265
regimen 24-48 hours post stroke. Encouraging clinical results in SCT's
Phase IIa BETAS stroke trial were presented at the International Stroke
Conference in February 2008, showing clinically relevant recovery in 8 of
8 patients who received the complete regimen. SCT is recruiting patients
for the multi-centre, double-blind, placebo-controlled Phase IIb
REGENESIS study for NTx(TM)-265 with primary endpoints of efficacy.

    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. 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 and multiple sclerosis.

    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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