Diatos Moves Its Lead Drug Toward Clinical Trials in Europe
Diatos S.A. announced the positive review and regulatory clearance of its lead drug DTS-201 Investigational Drug application by the Ethics Committee of Toulouse 1 (France). The AFSSAPS (French Health Products Safety Agency) has already been notified and the company will conduct this initial Phase I study beginning early 2005 in three leading oncology clinical centers in France and Belgium. The Phase I trials will mainly study the safety and pharmacokinetics of DTS-201, a doxorubicin prodrug that can be delivered selectively to tumors, in patients with advanced or metastatic solid tumors.
"This regulatory approval of the DTS-201 Investigational Drug application and the imminent initiation of clinical trials for DTS-201 in Europe is a significant milestone for Diatos," said Dr. John Tchelingerian, President and Chief Executive Officer. "Since we in-licensed DTS-201 from Medarex in April 2003 as a research compound, we have demonstrated our ability to rapidly and professionally move the drug into a clinical development stage. I am very pleased with the progress we have made with DTS-201, advancing our core focus in oncology drug development."
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