NR: Stem Cell Therapeutics Corp. Announces Second Positive Review
posted on
Jan 11, 2010 07:18PM
Stem Cell is a public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases.
Stem Cell Therapeutics Corp. Announces Second Positive Review by Data Safety and Monitoring Board for the Modified REGENESIS Phase IIb Stroke Trial and Provides Corporate Update
CALGARY, ALBERTA, Jan 11, 2010 (MARKETWIRE via COMTEX News Network) --
Stem Cell Therapeutics Corp. ("SCT" or the "Company") (TSX VENTURE: SSS) announced today it has been advised by the Data Safety Monitoring Board ("DSMB") that its second regularly scheduled safety analysis has been completed and the DSMB has recommended for the Phase IIb 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 REGENESIS Phase IIb acute ischemic stroke study. With all of the planned clinical trial sites in India, Canada and the U.S. recruiting patients for the Phase IIb acute ischemic stroke trial, and continuing with the steady patient enrollment rate, we anticipate Phase IIb patient enrollment to be complete by the end of Q1 2010 and for top-line data to be available after the 90-day patient assessment review period is complete, approximately by the end of Q2 2010. Notably, this remains aligned with the timeline stated in the announcement of the first positive DSMB review on November 20, 2009."
In regard to the traumatic brain injury ("TBI") clinical trial, the Company continues to work with Dr. David Zygun from the Department of Critical Care at the University of Calgary, Foothills Medical Centre. The Phase IIa TBI clinical trial is expected to begin enrolling patients in the first half of this year.
SCT is also working closely with Drs. Luanne Metz and Fiona Costello of the Multiple Sclerosis Clinic at the Foothills Medical Centre in Calgary, Alberta to facilitate the advancement of the multiple 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 company milestones that should, in turn, translate into maximized shareholder and corporate value."
About the Data Safety Monitoring Board ("DSMB"): The DSMB is a group of independent clinical experts that review the ongoing conduct of a clinical trial to ensure continuing patient safety. The mandate of SCT's DSMB is to provide objective, independent monitoring of patient safety during the Phase IIb acute ischemic stroke trial. This review was the second of three formal meetings scheduled that will occur over the duration of the Phase IIb stroke trial.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a 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 www.stemcellthera.com.