CALGARY, April 25 /PRNewswire-FirstCall/ - Stem Cell Therapeutics Corp. ("SCT") is pleased to announce that it has entered into an agreement to support a Phase IIa safety study examining the effects of NTx(TM)-265 in stroke patients. The regimen of drugs being tested in this study is referred to by SCT as NTx(TM)-265. The Phase IIa safety study has been reviewed and approved by both the United States Food and Drug Administration (FDA) and by the institutional review board (IRB) of the University of California, Irvine (UCI). The study will be conducted by Dr. Steven Cramer, a leading stroke specialist at UCI.
Dr. Joseph Tucker, President and CEO of SCT commented on today's announcement, "We are very pleased with the advancement of the NTx(TM)-265 stroke program into this Phase IIa safety study, now that approval to proceed has been received from both the FDA and the IRB. We believe that SCT's therapeutic approach holds great promise for the millions of individuals worldwide that suffer a stroke, and the initiation of this study brings us another step closer to our goal of developing this therapy".
Patient screening for this open label study, expected to enrol approximately 12 subjects, is anticipated to begin in the near future. This Phase IIa safety trial is designed to explore the safety profile of NTx(TM)- 265, a regimen of two currently marketed drugs, in new stroke patients. The protocol of this study directs that the initiation of drug administration takes place 24-48 hours after stroke onset. SCT anticipates that, if demonstrated to be successful, initiation of drug administration during such a therapeutic window would provide a greater potential for clinical usage than currently exists for thrombolytic drugs.
The design of this Phase IIa safety trial is based on that of SCT's previously reported, non-clinical animal study, which was carried out in a clinically relevant model of stroke. The primary study objective is to determine whether the therapy is safe as compared to historical controls, as assessed in terms of adverse events. Secondary objectives will provide further information on safety. The secondary objectives are to address, as compared to historical controls, clinical outcome, infarct volumes, and laterality towards activation in relevant stroke hemisphere regions when examined using functional magnetic resonance imaging (fMRI). Enrolment in this Phase IIa safety trial is expected to be completed approximately one year following study initiation.
"Establishing the safety of NTx(TM)-265 in stroke patients is a vital step in advancing SCT's goal of developing a much-needed therapy to promote the restoration of motor and neurological function lost due to stroke," remarked Dr. Alan Moore, Chief Clinical and Regulatory Officer of SCT.
About Stroke: Stroke represents the third leading cause of death in the United States and second worldwide, has an incidence of 700,000 victims in the U.S. each year. With current available therapies, less than 4% of stroke patients are treated with interventional drugs. The American Heart Association estimated the economic costs in the US at $54B in 2004 accompanied by an incalculable social cost.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a biotechnology company focused on the development of its technology platform and intellectual property to selectively induce a patient's own stem cells to proliferate in the brain. SCT's core technology, which includes its lead therapeutic product NTx(TM)-265, has been demonstrated to increase the number of innate adult stem cells that grow in place when this therapeutic approach is applied to test animals. SCT plans to develop this fundamental technology further for specific disease treatments such as stroke and potentially Huntington's disease, Alzheimer's disease and other neurodegenerative conditions.
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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.
Stem Cell Therapeutics Corp.CONTACT: For further information on Stem Cell Therapeutics Corp., visitwww.stemcellthera.com or contact : Dr. Joseph Tucker, Chief ExecutiveOfficer, Stem Cell Therapeutics Corp., Phone : (403) 245-5495,info@stemcellthera.com
