New EORTC compounds

Abstract

(NDDCC) was created with the purpose to establish a comprehensive anticancer drug development program covering all essential preclinical and clinical stages, a task executed by the New Drug Development Office (NDDO). The NDDCC makes selections of new candidates for development and has established guidelines for the formulation of investigational cytotoxic drugs (4), for toxicological studies (13) and phase I clinical trials (9). The NDDO aims at reducing the time lag between drug synthesis and introduction into the clinic, and maintaining an “EORTC Standard of Drug Development”. The NDDO has contact with drug suppliers, it decides which additional tests should be performed, it collects all available (screening) data for a new drug that is under development, and issues Information Sheets. Within the EORTC Screening and Pharmacology Group (SPG), chemists synthesize new compounds, others evaluate them for potential antitumour activity in primary and secondary in vitro and in vivo screening systems. In addition to this type ofdrug development for EORTC, agents are tested in selected models at the request of European national cancer research centers. The Clonogenic Assay Screening Study Group (CASSG) evaluates new drugs using clonogenic and other in vitro methods, and performs studies on tumour biology and normalization procedures. The main emphasis of the Pharmacokinetics and Metabolism Group (PAM) is on analytical methodology, quality control, classical pharmacokinetics, metabolism and formulation. With respect to drug formulation, cooperation exists between the EORTC, CRC and NC1 through the Joint Formulation Working Party. Before clinical evaluation by the Early Clinical Trials Group (ECTG) or the Clinical Screening Group (CSG), sufficiently large quantities of the drugs may be synthesized at the EORTC synthetic laboratory, located at the University of Twente, The Netherlands. Preclinical toxicology studies under strict Good Laboratory Practice (GLP) procedures are performed at TNO, Zeist, The Netherlands. A few examples of compounds that have been developed by the SPG or by national cancer research institutes with the help of the SPG, and that were studied in the clinic by members of the EORTC, are listed in Table 1. Special attention is drawn to their main