Stem Cell Therapeutics Corp. Announces Publication of Phase I Stroke Data
30 July 2009 - 10:38PM
Marketwired
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE:
SSS) is pleased to announce the acceptance and publication of the
paper entitled "Open labeled, uncontrolled pharmacokinetic study of
single intramuscular hCG dose in healthy male volunteers" by the
International Journal of Clinical Pharmacology and Therapeutics,
Vol. 47, August 2009. This paper was authored by Drs. Alan Moore,
President & CEO, Allen Davidoff, VP Product Development and Yan
Yang, Clinical Research Associate, all of SCT; Dr. Michael D. Hill
of Foothills Hospital at the University of Calgary, and Dr. Steven
C. Cramer, from the University of California, Irvine.
Dr. Allen Davidoff, VP of Product Development, commented as
follows:
"Acceptance by this highly respected, peer reviewed journal not
only permits us to share more of our knowledge of hCG's novel
effects with the scientific community but it is also a meaningful
developmental step for NTx®-265. Importantly, this study
demonstrated for the first time that hCG circulating in the blood
crosses the blood brain barrier leading to concentrations of hCG in
the cerebral-spinal fluid. This fundamental evidence, combined with
strong supportive basic science studies, supported initiation of
the BETAS Phase IIa clinical trial in patients with acute ischemic
stroke."
This study was designed to compare blood and cerebrospinal fluid
("CSF") pharmacokinetic characteristics of two forms of human
chorionic gonadotropin ("hCG"): Pregnyl® and Ovitrelle®. Two
separate groups, each with six older male human subjects, were
administered a single dose of either form of the drug at 10,000 IU
intramuscularly ("IM"), and then followed over a 36-hour period. No
significant difference was observed when plasma levels of hCG were
measured for either preparation of hCG (Peak plasma concentration:
316ï¿1/253 versus 270ï¿1/260 at 12 hours, 311ï¿1/238 versus
321ï¿1/260 IU/L at 24 hours; AUC: 10053ï¿1/21268 versus
8793ï¿1/21768, Pregnyl® and Ovitrelle®, mean ï¿1/2 SD,
respectively). Additionally, both forms of circulating 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 (2.0 and 1.2 IU/L;
range 1.9-2.1 and 1-1.4 IU/L for Pregnyl® and Ovitrelle®,
respectively). This preliminary study in normal human volunteers
suggested that the two forms of hCG tested, Pregnyl® and
Ovitrelle®, when administered IM, distribute in a similar fashion
into the circulation and CSF. Consequently, SCT concluded that
these two drugs likely demonstrate bioequivalent pharmacokinetics
with respect to the CSF.
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 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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