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

Main Category: Stroke
Also Included In: Clinical Trials / Drug Trials
Article Date: 31 Jul 2009 - 1:00 PDT

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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.

Source
Stem Cell Therapeutics Corp.

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