Stem Cell Therapeutics Corp. Reports Positive Results of Phase I Clinical Trial

21-Mar-2006

Stem Cell Therapeutics Corp. (SCT) reported positive results from its Phase I pharmacokinetic clinical trial in support of its lead therapeutic program for stroke, NTx(TM)-265. The trial demonstrated that, for the two drugs administered to healthy volunteers, no drug related adverse events were encountered and both drugs were detected in the cerebrospinal fluid (CSF) following intramuscular administration. The study was conducted on SCT's behalf by Medicon A/S of Birkerod, Denmark.

This Phase I clinical trial permitted characterization of the relationship between intramuscular administration, passage into blood and subsequent transport into the CSF. The study also generated new evidence that these two neural stem cell (NSC) proliferation inducing drugs reach the CSF when administered to human subjects with an intact blood-brain barrier.

NTx(TM)-265 is a therapeutic regimen of two drugs being developed by SCT for the treatment of stroke. The first drug administered in the regimen increases the number of NSCs located in the brain of a patient suffering from a recent stroke, which is accomplished by the systemic administration to the patient of an NSC proliferation inducing drug. There are several potentially useful versions of the proliferation inducing drug available and from amongst which SCT has the option to choose. Some of these versions are already approved and on market while other versions have not yet been approved for clinical use. The second drug administered in the regimen promotes the differentiation of these newly formed NSCs into new neurons. New neurons thus formed are anticipated to provide benefit to the patient through the replacement of the brain cells that were lost or damaged by the stroke. The differentiation step is achieved by administration of a differentiation inducing drug, one of several forms available, some approved and some not yet approved.

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