Stem Cell Therapeutics Corp.
TSX VENTURE : SSS

Stem Cell Therapeutics Corp.

September 15, 2008 16:13 ET

Stem Cell Therapeutics Corp. Receives 'No Objection Letter' From Health Canada for Its Traumatic Brain Injury Trial

First of its kind, Phase IIa traumatic brain injury trial given go-ahead by Health Canada

CALGARY, ALBERTA--(Marketwire - Sept. 15, 2008) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT") is pleased to announce it has received a No Objection Letter (NOL) from Health Canada for the Company supported, investigator led Phase IIa single centre, open label study to characterize the safety of human Chorionic Gonadotropin (hCG) & Erythropoietin (EPO) in severe traumatic brain injury (TBI). Dr. David Zygun, MD, MSc, FRCPC, Assistant Professor in the Departments of Critical Care Medicine, Clinical Neurosciences and Community Health Sciences, University of Calgary, Foothills Medical Centre, Calgary Health Region, will be the Principal Investigator for this Phase IIa TBI study.

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

"TBI represents a logical expansion of our therapeutic and clinical program scope. The therapeutic need in this area is extremely high as there are no marketed products approved for the treatment of TBI. The Phase IIa TBI therapeutic regimen is the same treatment being used in the Phase IIb REGENESIS stroke program thus we anticipate a supportive and expanding safety database in addition to endpoint measures of activity and efficacy."

The protocol of the Phase IIa TBI study has been reviewed by Health Canada. Approval by the University of Calgary's Office of Medical Bioethics is pending and once received will permit immediate enrollment at the Calgary Foothills Medical Centre.

Dr. David Zygun, Phase IIa TBI study Principal Investigator, Foothills Medical Centre, commented as follows:

"Traumatic injury is the most important cause of preventable morbidity and mortality in North America. Traumatic brain injury is common and is the single most important injury contributing to traumatic mortality and morbidity. Severe traumatic brain injury comprises only 10% of all brain injuries, but contributes the greatest proportion of deaths, disability, and cost related to traumatic brain injury both in Canada and around the world. Thus, the development of new a therapeutic regimen is urgently warranted. Utilizing rigorous methodology, we hope to ultimately translate initial discoveries from the laboratory of Dr. Samuel Weiss at the University of Calgary into improvements in patient outcomes. This initial safety assessment is an essential component of the process that will lead to larger efficacy trials."

About Traumatic Brain Injury: Traumatic injury to the head resulting from automobile accidents, concussive explosions or serious athletic impact to the head represents serious events that cause loss of independence and demand intense medical intervention with recovery periods that often persist for months or years. A therapy that induces improved neurological recovery or functional recovery after an acute injury would increase patient independence, decrease rehabilitation time and cost, represent a new important scientific advancement and medical development.

NTx(TM)-265 for Traumatic Brain Injury: The NTx(TM)-265 regimen is similar to that used in the REGENESIS Phase IIb stroke program. The 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 severe brain injury, and importantly, to direct functional recovery of motor, visual and cognitive capacity.

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.

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.

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