NewsJan 11, 2010 08:30 ET
Stem Cell Therapeutics Corp.Announces Second Positive Review by Data Safety and Monitoring Boardfor the Modified REGENESIS Phase IIb Stroke Trial and ProvidesCorporate Update
CALGARY, ALBERTA--(Marketwire - Jan.11, 2010) - Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSXVENTURE:SSS) announced today it has been advised by the Data SafetyMonitoring Board ("DSMB") that its second regularly scheduled safetyanalysis has been completed and the DSMB has recommended for the PhaseIIb acute ischemic stroke trial to continue as per protocol.
Dr. Alan Moore, President and CEO, commented as follows:
"64 patients have been enrolled to-date in our modified REGENESISPhase IIb acute ischemic stroke study. With all of the planned clinicaltrial sites in India, Canada and the U.S. recruiting patients for thePhase IIb acute ischemic stroke trial, and continuing with the steadypatient enrollment rate, we anticipate Phase IIb patient enrollment tobe complete by the end of Q1 2010 and for top-line data to be availableafter the 90-day patient assessment review period is complete,approximately by the end of Q2 2010. Notably, this remains aligned withthe timeline stated in the announcement of the first positive DSMBreview on November 20, 2009."
In regard to the traumatic brain injury ("TBI") clinical trial, theCompany continues to work with Dr. David Zygun from the Department ofCritical Care at the University of Calgary, Foothills Medical Centre.The Phase IIa TBI clinical trial is expected to begin enrollingpatients in the first half of this year.
SCT is also working closely with Drs. Luanne Metz and FionaCostello of the Multiple Sclerosis Clinic at the Foothills MedicalCentre in Calgary, Alberta to facilitate the advancement of themultiple sclerosis clinical program.
"2010 is going to be a banner year for SCT," said Dr. Alan Moore,"and we are working diligently to achieve a number of important companymilestones that should, in turn, translate into maximized shareholderand corporate value."
About the Data Safety Monitoring Board ("DSMB"): The DSMB is agroup of independent clinical experts that review the ongoing conductof a clinical trial to ensure continuing patient safety. The mandate ofSCT's DSMB is to provide objective, independent monitoring of patientsafety during the Phase IIb acute ischemic stroke trial. This reviewwas the second of three formal meetings scheduled that will occur overthe duration of the Phase IIb stroke trial.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. isa public 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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