The lead center for the study is the Russian Oncological Scientific Center n.a. N.N. Blokhin (ROSC) in Moscow. The national coordinator for the study is Professor S.A. Tyulyandin, MD, D. Med. Sc., Deputy Director of Clinical Oncology and Director of Clinical Pharmacology and Chemotherapy at ROSC.
CBL0137 is a proprietary small molecule with a unique mechanism of action that is in development for oncology applications. A program aimed at developing an intravenous formulation of CBL0137 is ongoing in the United States. A pre-Investigational New Drug Application (IND) meeting was conducted over the summer with the U.S. Food and Drug Administration in anticipation of filing an IND in the first quarter of 2013.