Stem Cell Therapeutics Corp has today announced that it will present the results of the Phase I open labeled, uncontrolled pharmacokinetic study of a single intra-muscular hCG dose in healthy male volunteers at the IXth World Conference on Clinical Pharmacology and Therapeutics.
The Phase I study was conducted to compare blood and cerebrospinal fluid (CSF) pharmacokinetic characteristics of two forms of human chorionic gonadotropin (hCG): Pregnyl.
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 as manifested 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.”
Source: Fox Business