Stem Cell Therapeutics Corp is pleased to announce positive interim results from its currently enrolling phase IIa- safety trial study "Beta-hCG + Erythropoietin in Acute Stroke".
This uncontrolled open label safety trial was designed to determine whether NTxTM-265 could be safely administered to a population of patients with acute stroke. In addition to the trial's primary safety endpoint, a number of secondary endpoints are being studied to characterize early indicators of efficacy in patients receiving this novel stroke therapy.
To date, five patients have been enrolled. Each had a moderate to severe stroke, defined by study entry criterion of National Institute of Health Stroke scale score between 6 (moderate) and 24 (severe); 0 being normal and 30 being non-responsive or comatose. Of these, four patients have safely completed the NTxTM-265 regimen of human chorionic gonadotropin (hCG) and erythropoietin (EPO), initiated 24-48 hours after stroke. Thus far, no drug-related Serious Adverse Events (SAE's) have been noted. A fifth study patient, a 79 year-old female with concomitant myocardial infarct and multi-organ failure, died before dosing was completed. This SAE was judged completely unrelated to the study drug regimen.
Accompanying the primary safety endpoint measures in this study is a battery of secondary endpoints that measure functional recovery. An earlier preclinical stroke study in rats established the proof of principle and impetus for proceeding into this clinical trial by demonstrating that administration of NTxTM-265, as compared to a placebo, was associated with rapid and robust recovery of visual and tactile motor control of forelimb function, as well as reduced final infarct volume. Infarct volume is the term used to describe the volume of brain tissue affected by blockage of blood flow to that tissue. Interim results from the current phase IIa NTxTM-265 stroke clinical trial show that each of the patients who completed the therapy demonstrated significant recovery from their stroke symptoms.