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Cleveland BioLabs Inc And Incuron Announce Notice Of Allowance From FDA To Commence Clinical Testing With Cbl0137


Tuesday, 2 Apr 2013 07:00am EDT 

Cleveland BioLabs Inc and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, announced the receipt of a Notice of Allowance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for CBL0137. A multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers is being finalized with the FDA. The primary objective of the study is to determine the maximally tolerated dose and recommend a Phase 2 dose for CBL0137 in these patients. Secondary objectives include describing the dose limiting toxicity, adverse event and pharmacokinetic profile of CBL0137, as well as documenting any objective responses. Exploratory objectives for the study include examining the relationship between tumor expression of Facilitates Chromatin Transcription (FACT), the molecular target of CBL0137, tumor response and the effect of CBL0137 on FACT expression in peripheral blood mononuclear cells and on soluble factors in serum. A Phase 1, single agent, dose escalation study of oral administration of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment is ongoing in the Russian Federation. 

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