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Cleveland BioLabs Reports First Quarter 2013 Financial Results And Development Progress

Operational Highlights

Enrollment of the Entolimod advanced cancer trial at Roswell Park Cancer Institute continues. To date, no serious adverse events have been reported.

The Company recently announced publication of studies identifying the liver as a key mediator of Entolimod's tissue-protective and anticancer activities in Proceedings of the National Academy of Sciences of the United States of America (PNAS), the official journal of the United States National Academy of Sciences. These studies provide new mechanistic insight into the radioprotection, radiomitigation and anticancer activities of Entolimod, strengthening the understanding of the drug's ability to mitigate radiation damage to the hematopoietic system and the hypothesis behind the ongoing clinical study in advanced cancer patients at Roswell Park Cancer Institute. The previously unanticipated effects of Entolimod on hepatocytes and the liver microenvironment defined in this work suggest that prevention or treatment of liver metastases and protection of the liver from various types of cell stress are additional areas of prospective clinical application for Entolimod.

Incuron, LLC, one of Cleveland BioLabs' majority-owned subsidiaries, is dosing the third cohort in a Phase 1, single agent, dose escalation study of the oral formulation of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment in the Russian Federation. An Investigational New Drug application for a multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers has been allowed by the U.S. Food and Drug Administration and the protocol is being finalized.

The final cohort of the dose escalation arm in Incuron's ongoing Phase 1 single-dose ascending trial of CBL0102 in advanced cancer patients with liver metastases has been completed, reaching at least the equivalent efficacious dose reached in preclinical studies.  Pending a decision from the review board, it may be decided that this trial has achieved its goals with regard to safety and may be concluded.  An investigator-initiated trial with CBL0102 in combination with Erlotinib in patients with advanced non-small-cell lung cancer is being prepared with plans to open it for patient accrual at the Case Comprehensive Cancer Center and the Cleveland Clinic.

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