Incuron Announce Start of Phase 1 Trial for CBL0137

The trial is being conducted at five leading oncology centers in the Russian Federation. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBL0137. Secondary objectives of the study include describing the safety profile, pharmacokinetics, and tumor response to CBL0137. The study includes a dose escalation arm of up to 36 patients divided into six cohorts, and a dose confirmation arm with an additional nine to twelve patients to be enrolled at the selected therapeutic dose. 

 

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. 

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