CALGARY, ALBERTA--(MARKET WIRE)--Sep 4, 2008 -- Stem Cell Therapeutics Corp.(CDNX:SSS.V - News) (“SCT”) has received results from the Data Safety Monitoring Board (DSMB) that provides oversight for the Company’s Phase IIb REGENESIS trial. The DSMB has completed a safety analysis and has recommended the trial continue as per the protocol.
The REGENESIS Phase IIb clinical trial is designed to demonstrate that the NTx(TM)-265 therapy is both a safe and effective therapy capable of improving recovery after acute ischemic stroke. The mandate of the DSMB is to provide objective, independent monitoring of patient safety during the REGENESIS trial. This review was the second of several regularly scheduled reviews by the four-member DSMB that will occur over the duration of the trial.
Dr. Alan Moore, President and CEO, commented as follows:
“With the DSMB’s decision to proceed, we are pleased to continue with this pioneering neuro-regenerative trial and we look forward to increasing enrollment at our Canadian sites through the coming months.”
About REGENESIS: NTx(TM)-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 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 functional recovery of motor, visual and cognitive capacity after acute ischemic stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx(TM)-265 regimen 24-48 hours post stroke. Encouraging clinical results from SCT’s Phase IIa BETAS stroke trial were presented at the International Stroke Conference in February 2008, showing clinically relevant recovery in 8 of 8 patients who received the complete regimen. SCT is recruiting patients for the multi-centre, double-blind, placebo-controlled Phase IIb REGENESIS study for NTx(TM)-265 with primary endpoints of efficacy and safety.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (CDNX:SSS.V - News) 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.
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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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Contact: Contacts: Stem Cell Therapeutics Corp. Alan Moore, PhD President and CEO (403) 245-5495 ext.224 Email: amoore@stemcellthera.com
Stem Cell Therapeutics Corp. Chloe Douglas-Crampton Investor Relations (403) 245-5495 ext. 221 Email: crampton@stemcellthera.com Website: http://www.stemcellthera.com Source: Stem Cell Therapeutics Corp.
