CALGARY, Sept. 29 /PRNewswire-FirstCall/ - Stem Cell Therapeutics Corp. ("SCT") announced today that they have signed a contract with Medicon A/S ("Medicon") of Birkerod, Denmark to perform a Phase I clinical trial. The contract encompasses submission of SCT's Phase I clinical trial protocol, screening, conduct and reporting of trial results. This agreement follows the successful clinical trial feasibility assessment and positive regulatory response that Medicon and SCT have achieved to date.
"This contract marks another step in the evolution of SCT into a clinical stage company. Medicon is a highly proficient and professional clinical trial institution, and this agreement represents our confidence in Medicon's ability to conduct clinical trials of the highest quality" said Dr. Joseph Tucker, President and CEO of SCT.
SCT's Phase I clinical trial protocol submission is expected in the next quarter with a response from Danish regulatory authorities anticipated within 30-40 days of submission.
The proposed Phase I clinical trial will be conducted at Medicon Clinical Pharmacology facilities in Denmark. The trial will enrol, study, and report data from 12 subjects over a duration of 2 months, following approval of the trial protocol by the Danish Regulatory Authorities.
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,firstname.lastname@example.org; For further information on Medicon, visitwww.medicon.dk or contact : Dr. Poul-Martin Haahr, Vice President ClinicalPharmacology, Medicon A