Stem Cell Therapeutics Corp.

Stem Cell Therapeutics Corp.

May 15, 2009 08:00 ET

Stem Cell Therapeutics Corp. Receives Formal Clearance From the FDA to Proceed With Their Phase IIb Stroke Trial

CALGARY, ALBERTA--(Marketwire - May 15, 2009) - Stem Cell Therapeutics Corp. ("SCT" or "the Company") (TSX VENTURE:SSS) is pleased to announce the U.S. Food and Drug Administration ("FDA") has now issued a formal letter to the Company confirming immediate removal of the clinical hold placed on the Phase IIb stroke trial, September 18, 2008. This permits re-initiation of clinical studies for NTx®-265.

Dr. Alan Moore, President and CEO, commented as follows:

"We are very pleased that the FDA has followed up their verbal confirmation so quickly with a formal letter to lift the clinical hold, allowing us to initiate the Phase IIb clinical trial with limited delay."

About REGENESIS: 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.

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 brain and nerve 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, multiple sclerosis, Huntington's disease, Alzheimer's disease, and ALS.

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.

The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

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