SSS NEWS:Headline: Stem Cell Therapeutics Corp. Provides Update on Modified REGENESIS Phase IIb Stroke Trial
Symbol: SSS
CALGARY, ALBERTA--(Marketwire - Feb. 16, 2010) - Stem Cell TherapeuticsCorp. (TSX VENTURE:SSS) ("SCT" or the "Company") announced today thatit will focus the remaining patient enrollment of the modified PhaseIIb stroke trial in Canada and the U.S. and will no longer recruitpatients from India. As standard practice, the Drug Controller Generalof India ("DCGI") limits the amount of patients that participate inclinical trials from companies that are not located in India and SCThas been advised that the stroke trial has reached its limit ofrecruiting patients from India.
This decision by the DCGI was not based on any safety or mortalityconcerns. As announced, the Data Safety Monitoring Board ("DSMB")completed three safety analyses and recommended for the Phase IIb acuteischemic stroke trial to continue as per protocol after each analysis.
Dr. Alan Moore, President and CEO, commented as follows:
"We have moved quickly through the modified REGENESIS Phase IIb stroketrial so far, having enrolled 96 patients in six months, and we willnow be focusing our remaining patient recruitment efforts in Canada andthe U.S. instead of India. Given our historic recruiting rate in NorthAmerica, it now appears unlikely that we will able to complete theenrollment of 128 patients by the end of Q1 2010, as previouslyannounced. We will also be reviewing alternate methods of data analysisto possibly allow an earlier study conclusion prior to recruiting theoriginal goal of 128 patients."
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is apublic biotechnology company (TSX VENTURE:SSS) focused on thedevelopment and commercialization of drug-based therapies to treatcentral nervous system diseases. SCT is a leader in the development oftherapies that utilize drugs to stimulate a patient's own resident stemcells. The Company's programs aim to repair brain and nerve functionlost due to disease or injury. The Company's extensive patent portfolioof owned and licensed intellectual property supports the potentialexpansion into future clinical programs in numerous neurologicaldiseases such as traumatic brain injury, multiple sclerosis,Huntington's disease, Alzheimer's disease, and ALS.
For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.
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Except for historical information, this press release may containforward-looking statements, which reflect the Company's currentexpectation regarding future events. These forward-looking statementsinvolve risk and uncertainties, which may cause but are not limited to,changing market conditions, the successful and timely completion ofclinical studies, the establishment of corporate alliances, the impactof competitive products and pricing, new product development,uncertainties related to the regulatory approval process and otherrisks detailed from time to time in the Company's ongoing quarterly andannual reporting.
