Stem Cell Therapeutics Corp. To Present Published Data At The IXth World Conference On Clinical Pharmacology & Therapeutics

Main Category: Neurology / Neuroscience
Article Date: 29 Jul 2008 - 4:00 PDT

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Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) announced 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): PregnylTM, derived from human urine, and OvitrelleTM a recombinant form. This preliminary study showed that the two forms of hCG tested, OvitrelleTM and PregnylTM, 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)

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 NTxTM-265

NTxTM-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 NTxTM-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 NTxTM-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.

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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.

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Stem Cell Therapeutics Corp.