Stem Cell Therapeutics Corp.

Stem Cell Therapeutics Corp.

July 20, 2009 08:48 ET

Stem Cell Therapeutics Receives Clearance from Health Canada to Proceed with the Phase IIb Clinical Stroke Trial

CALGARY, ALBERTA--(Marketwire - July 20, 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.

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 such as traumatic brain injury and multiple sclerosis.

For further information on Stem Cell Therapeutics Corp., visit

These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.

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.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information