The News

Diatos moves its lead drug, DTS-201, toward clinical trials in Europe

16/12/2004

PARIS, FRANCE – Dec. 16, 2004 –  Diatos S.A., a privately held biopharmaceutical company, announced today 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.”

About DTS-201
DTS-201 consists of doxorubicin (a marketed cytotoxic compound used in treating several cancer types) conjugated to a proprietary peptide technology discovered in 1996 by Pr. André Trouet and his team at Université Catholique de Louvain (Belgium). DTS-201 comprises a four-amino acid peptide chemically conjugated to the doxorubicin compound whose activity is inhibited when conjugated to the peptide (DTS-201 is a prodrug of doxorubicin).  Preclinical studies indicate that the peptide is cleaved off by endopeptidases released by cancer cells when the prodrug molecule reaches the vicinity of a tumor, thereby freeing the doxorubicin compound. The free doxorubicin is then expected to exert its cytotoxic effects on the cancer cells.  The ability to target and deliver anti-cancer agents preferentially to tumors and limit their toxic effect on normal cells is expected to result in better clinical outcomes both in terms of improved response rates and lower toxicity.

About Diatos
Diatos is using its proprietary Diatos Peptide Vector (DPV) intra-cellular/intra-nuclear delivery technology (VectoCell®) and Tumor-Selective Prodrug (TSP) cancer-targeting technology to develop new therapies for cancer and other serious diseases. With its first compound, DTS-201, expected to enter clinical trials beginning of 2005, Diatos is also expanding its product pipeline with new compounds that utilize its VectoCell® or TSP technologies as well as with in-licensed clinical-stage cancer therapies. Diatos has entered into research collaboration agreements with several European and US biotechnology and pharmaceutical companies for the use of VectoCell® technology.

Founded in 1999 as a spin-off from Institut Pasteur, Diatos has raised 33 million Euro to date from Sofinnova Partners (France), GIMV (Belgium), InterWest Partners (USA), Credit Lyonnais Private Equity (France), AGF Private Equity (France), NIF Ventures (Japan), Société Générale Asset Management (France), Sopartec (Belgium), Innoven Partenaires (France) and BFF (Belgium). Diatos is headquartered in Paris and has operations in Belgium and the United States.