Cleveland BioLabs (CBLI) Gets Russian Regulatory Approval for CBLC137 Phase 1B
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Cleveland BioLabs, Inc. (Nasdaq: CBLI) and its majority-owned subsidiary, Incuron, LLC today announced that a new Investigational New Drug (IND) application for clinical testing of CBLC137 was opened with the regulatory authority of the Russian Federation.
A Phase 1b, dose escalation study of the oral formulation of CBLC137 in subjects with advanced solid tumors that are resistant or refractory to standard care treatment, will be conducted at five sites in the Russian Federation. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBLC137. Secondary objectives of the study include describing the safety profile, pharmacokinetics, and anti-tumor response to CBLC137. 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, a leading oncology center in Russia. 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. Dr. Tyulyandin is one of the leading experts in cancer chemotherapy therapy in Russia. Innovative methods for the treatment of different malignant neoplasms have been developed under his leadership.
A Phase 1b, dose escalation study of the oral formulation of CBLC137 in subjects with advanced solid tumors that are resistant or refractory to standard care treatment, will be conducted at five sites in the Russian Federation. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBLC137. Secondary objectives of the study include describing the safety profile, pharmacokinetics, and anti-tumor response to CBLC137. 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, a leading oncology center in Russia. 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. Dr. Tyulyandin is one of the leading experts in cancer chemotherapy therapy in Russia. Innovative methods for the treatment of different malignant neoplasms have been developed under his leadership.
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