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. FACT expression will also be tested on patient's tumor tissue retrospectively to determine if the tumor signal can help guide patient selection for future studies.

Incuron, a joint subsidiary of the Bioprocess Capital Ventures closed-end investment fund and Cleveland BioLabs, Inc. (NASDAQ:CBLI), announced the publication of studies describing the Facilitates Chromatin Transcription (FACT) complex as an accelerator of tumor transformation and a potential marker and target for aggressive cancers in Cell Reports, a peer-reviewed journal. FACT is the molecular target for Curaxins, a new class of anti-cancer compounds being developed by Incuron. The reported studies were led by scientists at RPCI.

04.04.2012

Incuron, a joint subsidiary of the Bioprocess Capital Ventures closed-end investment fund and Cleveland BioLabs, Inc. (NASDAQ:CBLI), today 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.

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