Stem Cell Therapeutics Corp. and Medicon A/S Sign Contract to Perform Phase I Clinical Study

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CALGARY, Sept. 29 /CNW/ - 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.


Source Stem Cell Therapeutics Corp.



Posted on October 17, 2005 05:32 PM

 
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