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news.Stem Cell Therapeutics has entered into an agreement to support a phase IIa safety study examining the effects of NTx-265 in stroke patients.
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The study has been reviewed and approved by both the FDA and by the institutional review board (IRB) of the University of California, Irvine (UCI).
Patient screening for the open label study, which is expected to enrol approximately 12 subjects, is anticipated to begin in the near future. Thesafety trial is designed to explore the safety profile of NTx-265, a regimen of two currently marketed drugs, in new stroke patients.
According to study protocol, drug administration will take place 24 to 48 hours after stroke onset. Stem Cell Therapeutics (SCT) anticipates that, if demonstrated to be successful, initiating drug administration during such a therapeutic window would provide a greater potential for clinical usage than currently exists for thrombolytic drugs.
“We are very pleased with the advancement of the NTx-265 stroke program into this phase IIa safety study, now that approval to proceed has been received from both the FDA and the IRB,” commented Dr Joseph Tucker, president and CEO of SCT. “We believe that SCT’s therapeutic approach holds great promise for the millions of individuals worldwide that suffer a stroke, and the initiation of this study brings us another step closer to our goal of developing this therapy.”