Stem Cell Therapeutics Corp. to Present Published Data at the IXth World Conference on Clinical Pharmacology & Therapeutics
July 28 2008 - 11:00AM
Marketwired
CALGARY, ALBERTA (TSX VENTURE: SSS) announced today that Dr.
Allen Davidoff, VP Product Development, will be presenting data
from the Phase I open labeled, uncontrolled pharmacokinetic study
of a single intra-muscular (IM) hCG dose in healthy male volunteers
at the IXth World Conference on Clinical Pharmacology and
Therapeutics being held in Quebec City, Quebec, July 27th - August
1st, 2008.
The Phase I study was conducted to compare blood and
cerebrospinal fluid (CSF) pharmacokinetic characteristics of two
forms of human chorionic gonadotropin (hCG): Pregnyl(TM), derived
from human urine, and Ovitrelle(TM) a recombinant form. This
preliminary study showed that the two forms of hCG tested,
Ovitrelle(TM) and Pregnyl(TM), when administered IM, distributed in
a similar fashion into the circulation and CSF. Consequently, it
was concluded that these two drugs demonstrate similar
pharmacokinetics with respect to the CSF.
This study used two separate groups of six older male human
subjects. Each individual was dosed once with either form of the
drug at 10,000 IU IM, and subjects were followed over a 36-hour
period. When plasma levels of hCG were studied for either
preparation of hCG, no difference was observed. Additionally both
forms of hCG distributed to the central nervous system (CNS) as
manifest by an increased number of subjects whose CSF samples
showed detectable levels of hCG in their CSF over a 36-hour period.
Similarly, there was no significant difference between the two
forms when distribution to the CSF was compared at 36 hours.
Dr. Allen Davidoff, VP of Product Development, commented as
follows:
"This important study, for the first time, demonstrated that
administering hCG systemically in man results in appreciable
amounts of hCG in the central nervous system and established that
drug would be present and available to signal neurogenesis and
promote a patient's functional recovery during the time of an acute
neurological injury. This finding permitted initiation of the now
complete and very successful BETAS trial."
About the IXth World Conference on Clinical Pharmacology &
Therapeutics (CPT 2008)
(http://www.cpt2008.com/e_mainmenu/welcome_e.shtml): The CPT
Conference is an international meeting held every four years to
bring together the largest, most comprehensive group of researchers
and decision makers in the field of Clinical Pharmacology and
Therapeutics. The purpose of this conference is to promote
international sharing, co-operation and open discussions on the
advances in drug research and utilization. For CPT 2008 in Quebec
City, 2500 physicians, pharmacists, researchers, university
professors and graduate students from all over the world are
expected to attend.
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. SCT is recruiting patients for the
multi-centre, double-blind, placebo-controlled REGENESIS Phase IIb
stroke study for NTx(TM)-265 with primary endpoints of efficacy.
Patient enrollment is expected to be complete by the end of 2008
with top-line efficacy data expected to be released before the end
of the first quarter of 2009.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp.
is a Canadian public biotechnology company (TSX-V: 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
Webmail: www.stemcellthera.com
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