Stem Cell Therapeutics Corp.

Stem Cell Therapeutics Corp.

December 04, 2007 08:34 ET

Stem Cell Therapeutics Announces Receipt of No Objection Letter From Health Canada for Its Phase IIb Clinical Trial in Stroke

CALGARY, ALBERTA--(Marketwire - Dec. 4, 2007) - Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) is pleased to announce that the Company has received a No Objection Letter (NOL) from Health Canada for the REGENESIS trial (a Phase II prospective, Randomized, double-blind, placEbo controlled study of NTx™-265: human chorionic Gonadotropin (hCG) and EpoetiN alfa (EPO) in acute iSchemIc Stroke patients), its Phase IIb clinical trial in acute stroke investigating efficacy and safety endpoints.

This Canadian based, double-blinded, placebo controlled trial with NTx™-265 in acute ischemic stroke patients will be conducted in association with the Canadian Stroke Consortium. The trial is projected to recruit at approximately 15 to 20 enrolling centers across Canada with a target enrollment of 120 patients. SCT is targeting to have one or two centers activated for recruitment before year-end and to have full enrollment of the trial completed before the end of 2008.

SCT is also pleased to announce the completion of the BETAS trial (Beta-hCG + EryThropoietin in Acute Stroke), an investigator lead Phase IIa clinical trial examining the safety profile, effects, and efficacy of the acute stroke-therapy regimen NTx™-265 after reaching the original target of 12 patients. Results of the Phase IIa acute stroke trial will be presented in February of 2008 at the American Stroke Association's International Stroke Conference in New Orleans, LA.

"We are delighted to receive the NOL from Health Canada as it marks a significant step in our clinical development program. With the hard work and dedication from the clinical team at SCT, we will progress swiftly and confidently into the REGENSIS trial in stroke patients with NTx™-265," said Dr. Alan Moore, President and CEO of SCT. "Additionally, we are pleased with the safety and efficacy information received to date from the patients enrolled in the BETAS trial, and final results will be reported by Dr. Steven Cramer, Principal Investigator for the study, at the International Stroke Conference in New Orleans this coming February."

About NTx™-265: NTx™-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 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 NTx™-265 regimen 24-48 hours post stroke. Similar results have been found in SCT's phase IIa safety trial, BETAS, as announced on April 10, 2007. SCT will be initiating a multi-centre, double-blind, placebo-controlled Phase IIb study, REGENESIS with NTx™-265 by the end of this year.

About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The company's programs aim to repair neurological function lost due to disease or injury. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.

Stem Cell Therapeutics Corp. was also recently selected to be one of Canada's Top 10 Life Sciences Companies for the second year running (

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Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.

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