CALGARY, Oct. 3 /PRNewswire-FirstCall/ - Stem Cell Therapeutics Corp. ("SCT") announced today that Medicon A/S ("Medicon") of Birkerod, Denmark has submitted a Phase 1 clinical trial study protocol to the Danish Regulatory Agency on behalf of SCT for its NTx(TM)-265 program for the treatment of stroke. Stroke, the third leading cause of death in the United States and second worldwide, has an incidence of 700,000 patients in the U.S. each year. With currently 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.
"I am pleased by the continued advancement of this clinical program," said Dr. Alan Moore, Chief Clinical and Regulatory Office of SCT. "With the successful achievement of each milestone we move closer to our goal of developing this novel treatment for the vast number of stroke victims who have no significant therapeutic options available to them".
Submission of the Phase I protocol for regulatory review advances SCT to the same developmental stage as other leading stem cell companies targeting neurological disorders. Dr. Joseph Tucker, President and CEO of SCT said, "To SCT's knowledge, none of the bellwether U.S.-based stem cell companies, such as Geron Corporation and StemCells Inc., developing treatments for neurological disorders have received approval to initiate clinical studies."
A protocol review by the Danish Medicines Agency is typically conducted within 30 to 40 days following receipt of the submission. Once approval from the Danish regulatory authorities is received, screening of subjects will be initiated. Administration of drug is expected to begin within 30 days of the first subject being screened. "Successful completion of this Phase I trial will provide key information regarding drug administration and pharmacokinetics in healthy volunteers and expedite advancement toward our planned Phase II trials in stroke patients," said Dr. Allen Davidoff, V.P. Product Development.
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, prior to evaluating safety and efficacy in stroke patients. The duration of the Phase I trial is expected to be eight weeks.
Several stem cell-based approaches for the treatment of neurological disorders exist, including transplantation of stem cells or progenitor cells, and stimulation of innate stem cells. To our knowledge, SCT is the only company using the stimulation of innate stem cells as its approach to develop a therapy for the vast and largely under-treated population of stroke patients.
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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Stem Cell Therapeutics Corp.