A CD&D

Stem Cell Therapeutics (SCT; Calgary, Alberta) at this year's Stroke meeting reported favorable results from its Beta-hCG + Erythropoietin in Acute Stroke (BETAS) Phase IIa, open label, safety trial conducted at the University of California, Irvine and Hoag Presbyterian Memorial Hospital (Newport Beach, California). The company said that the BETAS trial is the first to test the safety of NTxTM-265 in patients suffering acute ischemic stroke and to conduct a preliminary assessment of functional recovery in this patient population.

The trial showed no serious adverse events related to NTxTM-265 in the 13 patients enrolled. Of these, eight patients completed the 90-day assessment term and each showed a clinically relevant improvement in their National Institutes of Health Stroke Scale (NIHSS) score of 4 points or greater. Patients entered the trial with NIHSS scores ranging from 6 to 19 (moderate to severe).

In these patients, average baseline NIHSS was 8.3 plus/minus 4.1 (mean plus/minus SD) and improved in eight of eight patients to an average day-90 NIHSS of 2.5 plus/minus 1.8, an improvement in NIHSS score of 5.8 plus/minus 2.5 points.

Five of the eight patients had a day-90 Barthel Index score of 95-100 (out of 100), a score consistent with "excellent" outcome. Specific assessments of neurological recovery affected by NTxTM-265 were also favorable, including the Arm Motor Fugl-Meyer Scale, an arm motor recovery assessment; Trailmaking A test, a measure of cognitive function; and measures of neglect and aphasia.

Further, the drug regimen decreased the size of the infarct in six out of eight patients overall, given a mean decrement in all eight of about 10%.

Dr. Alan Moore, president/CEO of SCT, said, "The encouraging results from this trial are consistent with results previously reported as an interim analysis on April 10, 2007, and suggest great promise for our NTxTM-265 treatment for stroke, but interpretation of results from the BETAS trial is limited by small patient sample size and absence of a placebo control group.

"Nevertheless, these results represent an important first step in defining the safety of the NTxTM-265 regimen in patients with acute neurologic injury. Equally promising is early evidence in a small group of patients that consistent recovery of motor, cognitive and visual function may occur as a result of NTxTM-265 neuro-regenerative therapy for stroke."

The company said that the next development step for SCT is to build on the results from the BETAS trial with the initiation of the REGENESIS proofo-f-concept study.

REGENESIS is a Phase IIb prospective, randomized, double-blind, placebo controlled study of NTxTM-265: human Chorionic Gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients. The REGENESIS trial will be conducted at approximately 15-20 Canadian clinical trial centers and aims to enroll 134 patients in 2008.

NTxTM-265 is a therapeutic regimen of two approved and clinically-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke.

The objective of the regimen is to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke. Animal studies have shown a significant recovery in motor function after receiving the NTxTM-265 regimen 24 to 48 hours post-stroke.

The company said that similar results have been found in its Phase IIa BETAS safety trial, as announced on April of last year.

SCT also has initiated a multi-centre, double-blind, placebo-controlled Phase IIb REGENESIS study for NTxTM-265 with primary endpoints of efficacy.