Incuron and Cleveland Biolabs launch clinical trials for new cancer drug
17 Oct '12
Moscow-based biotech company Incuron and its US partner Cleveland BioLabs, Buffalo, NY (Nasdaq:CBLI) have announced that the first patient was dosed in a Phase 1, single agent, dose escalation study of the oral formulation of CBL0137 in subjects with advanced solid tumors that are resistant or refractory to standard of care treatment.
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.
Incuron is a JV between Cleveland BioLabs and its Russian partner VC fund, Bioprocess Capital Ventures. Incuron is now also a resident of Skolkovo, Russia’s largest state-sponsored innovation hub just outside Moscow.
The trial is being conducted at five leading oncology centers in the Russian Federation. The lead center for the study is the N.N. Blokhin Russian Oncological Scientific Center (ROSC) in Moscow.
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.