Stem Cell Therapeutics Corp.

Stem Cell Therapeutics Corp.

July 30, 2009 08:38 ET

Stem Cell Therapeutics Corp. Announces Publication of Phase I Stroke Data

CALGARY, ALBERTA--(Marketwire - July 30, 2009) - 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: 316±53 versus 270±60 at 12 hours, 311±38 versus 321±60 IU/L at 24 hours; AUC: 10053±1268 versus 8793±1768, Pregnyl® and Ovitrelle®, mean ± 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.

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