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Stem Cell Therapeutics Receives Clearance From Health Canada To Proceed With The Phase IIb Clinical Stroke Trial
Posted by: admin in Pharmacy Drugs on August 11th, 2009
Stem Cell Therapeutics Corp. (TSX VENTURE:SSS)(”SCT” or “the Company”) has received a No Objection Letter (”NOL”) from Health Canada for the modified REGENESIS protocol using NTx®-265 for a Phase IIb clinical trial treating acute ischemic stroke.
Dr. Alan Moore, President and CEO, commented as follows:
“We are pleased that Health Canada has issued an NOL for the modified REGENESIS clinical trial. This welcome development means that we are able to proceed with recruitment of patients, testing the NTx®-265 regimen in patients with acute ischemic stroke in Canada again and demonstrating the ability of this novel approach to speed recovery from stroke disabilities. This satisfying development can be directly attributed to the perseverance and strong belief of all the SCT staff that NTx®-265 will, in the future, redefine the therapies available to patients recovering from acute ischemic stroke, traumatic brain injury, and neurological disease.”
About REGENESIS (a Phase II prospective, randomized, double-blind, placebo controlled study of NTx®-265: hCG and epoetin alfa in acute ischemic stroke patients): NTx®-265 is SCT’s lead 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 treatment 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 the acute ischemic stroke. Encouraging clinical results from SCT’s BETAS Phase IIa stroke trial were presented at the International Stroke Conference in February 2009, showing clinically relevant recovery in 12 of 12 patients who received the complete treatment. SCT received clearance from the FDA to proceed with the Phase IIb stroke trial on May 15, 2009.
Source
Stem Cell Therapeutics Corp.
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