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加拿大Stem Cell Therapeutic
加拿大干細胞治療公司

Stem Cell Therapeutics Corp. is a Canadian biotechnology company (TSX-V: 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.

Stem Cell Therapeutics Corp. is a biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system (“CNS”) disorders. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident autologous stem cells. The Company's programs aim to repair neurological functions lost due to disease or injury. SCT’s stem cell regenerative therapeutic approach was founded on the work of Dr. Samuel Weiss, Director of the Hotchkiss Brain Institute at the University of Calgary, who was awarded the Gairdner Award in April 2008 for this work on neural stem cells. SCT’s lead product, NTx?-265, targets the treatment of stroke by repurposing approved and clinically well defined drugs. The Company's extensive patent portfolio supports the potential expansion into future clinical programs in numerous other neurological diseases such as traumatic brain injury and multiple sclerosis.

SCT’s primary program, 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 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 NTx?-265 regimen 24-48 hours post stroke. Encouraging final clinical results from SCT’s completed BETAS (Beta-hCG + Erythropoietin in Acute Stroke) 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 regimen. In May of 2008, SCT began recruiting patients for its multi-centre, double-blind, placebo-controlled REGENESIS (a Phase II prospective, randomized, double-blind, placebo controlled study of NTx?-265: hCG and epoetin alfa in acute ischemic stroke patients) Phase IIb stroke study for NTx?-265 with primary endpoints of safety and efficacy.

Due to an unrelated German clinical study, the REGENESIS Phase IIb clinical trial was officially placed on clinical hold in September 2008 at the request of Health Canada and the U.S. Food and Drug Administration (“FDA”). The clinical hold was formally lifted by FDA on May 14, 2009. Health Canada approved the modified REGENESIS Phase IIb stroke trial on July 20, 2009and the Drug Controller General of India (“DCGI”) followed shortly thereafter on July 21, 2009 issuing the Company a No Objection Letter (“NOL”) for the same protocol. This trial is co-Led by two principal investigators: Dr. Steven C. Cramer from the University of California, Irvine and Dr. Michael D. Hill of Foothills Hospital at the University of Calgary. The recruitment target for this study is to enroll 128 patients. The Indian, U.S., and Canadian protocols share similar design, as well as safety and efficacy endpoints.

On August 11, 2009, the Company announced the enrollment of its first patient in the dose response designed modified REGENESIS Phase IIb stroke trial. It is expected that the Company will complete recruiting by the end of Q1 2010 in the modified REGENESIS phase IIb stroke trial using NTx?-265. A top-line read of the data is anticipated to be available.