CALGARY, Nov. 29 /PRNewswire-FirstCall/ - Stem Cell Therapeutics Corp. ("SCT") is pleased to announce completion of screening and initiation of dosing in its Phase I Clinical Study of NTx(TM)-265, SCT's program for the treatment of stroke. This Phase I Clinical Trial is currently being conducted on SCT's behalf by Medicon A/S ("Medicon") of Birkerod, Denmark.
The Phase I trial is designed to characterize the pharmacokinetic profile of two currently marketed drugs, identified by SCT as effective in non- clinical models of stroke. As previously reported, the Phase I study subjects will be dosed in two groups staggered by approximately two weeks. The duration of the Phase I trial is anticipated to be eight weeks. SCT also has a Phase II trial planned to evaluate safety and efficacy of its NTx(TM)-265 therapy in stroke patients.
"Dosing our first patient represents a turning point in the evolution of Stem Cell Therapeutics Corp. from a pre-clinical research and development company into a company with the capacity to rapidly graduate promising stem cell technologies through clinical safety and efficacy testing in man", said Dr. Alan Moore, Chief Clinical and Regulatory Officer of SCT.
Stroke, which is 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. The American Heart Association estimated the economic costs in the US at $56.8B for 2005. Because of the lack of effective therapies currently available it is estimated that less than 4% of stroke patients are treated with interventional drugs.
About Medicon A/S: Medicon A/S is a 20 year old Drug Development Organisation with a documented success in clinical research with scientific impact and with a track record of high quality trials. With its team of +60 FTE specialists it offers fast track solutions within all services for phases I-IV studies, from synopsis to NDA, data management & statistics, QM, audit and training. Medicon Clinical Pharmacology is one of Europe's largest and most modern facilities with 60 beds offering Phase I trials in healthy volunteers, Phase IIa trials in patients recruited from regional hospitals. Medicon Clinical Pharmacology offers special studies. i.e. glucose clamp studies and thorough QT-trials.
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. For further information on Medicon, visitwww.medicon.dk or contact Dr. Poul-Martin Haahr, Vice President ClinicalPharmacology, Medicon A/S, Phone : +45 7020 3139, pmh@medicon.dk
