Stem Cell Therapeutics Corp. said the US Food and Drug Administration (FDA) has allowed its investigational new drug application (IND) to proceed. The IND-opening study is a double-blind, randomised, placebo-controlled phase IIb clinical trial of its lead programme, NTxTM-265, for the treatment of acute ischemic stroke.

The FDA response allows initiation of the US phase IIb clinical trial in acute ischemic stroke, led by the Principle Investigator of the phase IIa 'BETAS' stroke trial, Dr. Steven C. Cramer, at the University of California, Irvine. Dr. Cramer is also the co-Lead Investigator of the Canadian phase IIb 'REGENESIS' trial along with Dr. Michael Hill at the Foothills Hospital, University of Calgary.

This US phase IIb acute ischemic stroke trial is similar to the previously announced Canadian-based 'REGENESIS' trial. The recruitment target for this US study is to enrol 20-30 patients at 3-4 enrolling sites. This will accompany the currently enrolling Canadian phase IIb 'REGENESIS' stroke trial, projected to enrol 134 patients at approximately 18 sites. The US and Canadian phase IIb clinical stroke studies share similar protocols, safety and efficacy endpoints.

Dr. Alan Moore, President and CEO, SCT, said, "We are very excited by the FDA's acceptance of the IND for our US phase IIb acute ischemic stroke trial. This acceptance demonstrates that SCT has met an important clinical development milestone especially for a non-US biotech company. This US companion study of the Canadian phase IIb study is a key component of the pre-pivotal phase III programme as we aspire to meet worldwide regulatory acceptance and because the FDA sets a critical regulatory standard."

Part of the FDA evaluation process included reviewing the patient safety and efficacy results from the phase IIa 'BETAS' clinical stroke trial. Favourable results from the phase IIa 'BETAS' stroke trial was released February 20, 2008.

NTxTM-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke. The twin objectives of the regimen are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual and cognitive recovery after acute ischemic stroke. Animal studies have shown a significant recovery in motor function after receiving the NTxTM-265 regimen 24-48 hours post stroke. Encouraging clinical results in SCT's phase IIa 'BETAS' stroke trial were presented at the International Stroke Conference in February 2008, showing clinically relevant recovery in 8 of 8 patients who received the complete regimen. SCT is enrolling sites for the multi-centre, double-blind, placebo-controlled phase IIb 'REGENESIS' study for NTxTM-265 with primary endpoints of efficacy; enrolment to be complete by the end of 2008 with top-line efficacy data to be released before the end of the first quarter of 2009.