Stem Cell Therapeutics to support clinical safety study for stroke patients

By Elaine Rigoli

Tampa, Fla., April 25 - Stem Cell Therapeutics Corp. has entered into an agreement to support a phase 2a safety study, reviewed and approved by both the Food and Drug Administration and by the institutional review board of the University of California, Irvine, examining the effects of NTx-265 in stroke patients.

Patient screening for this open label study, expected to enroll about 12 subjects, is anticipated to begin soon.

This phase 2a safety trial is designed to explore the safety profile of NTx-265, a regimen of two currently marketed drugs, in new stroke patients.

The protocol of this study directs that the start of drug administration take place 24 to 48 hours after stroke onset.

Stem Cell said it anticipates that, if demonstrated to be successful, initiation of drug administration during such a therapeutic window would provide a greater potential for clinical usage than currently exists for thrombolytic drugs.

The design of this safety trial is based on the company's previously reported, non-clinical animal study, which was carried out in a clinically relevant model of stroke.

The primary study objective is to determine whether the therapy is safe as compared to historical controls, as assessed in terms of adverse events.

Secondary objectives will provide further information on safety.

Stem Cell Therapeutics is a Calgary, Alta.-based biotechnology company focused on the development of its technology platform and intellectual property to selectively induce a patient's own stem cells to proliferate in the brain.

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