A multi-center Phase I trial of CBL0102 is ongoing in the Russian Federation in patients with liver metastases of solid tumors of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or does not exist. The trial is dosing the sixth cohort in its dose-escalation arm and, subsequent to the completion of the dose-escalation arm, will enroll an efficacy arm.

09.06.2013

BUFFALO, NY--(Marketwire - Aug 10, 2011) - Cleveland BioLabs, Inc. (NASDAQ: CBLIand Incuron, LLC today announced that Science Translational Medicine, a leading peer-reviewed research magazine dedicated to communication and cross-fertilization among basic, translational, and clinical research, has published breakthrough findings regarding the deciphered mechanism of action of anticancer drug candidates, Curaxins. The paper titled: "Curaxins: Anticancer Compounds that Simultaneously Suppress NF-kappaB and activate p53 by Targeting FACT," shows that Curaxins' ability to inhibit tumor cell growth and division is mediated by functional inactivation of a chromatin remodeling complex named Facilitates Chromatin Transcription (FACT), which makes it a novel cancer treatment target. The paper is co-authored by a large group of investigators, predominantly from Cleveland BioLabs and Roswell Park Cancer Institute, led by Katerina Gurova, Ph.D., former Director of Anticancer Drug Discovery at CBLI, who is currently on faculty at Roswell Park.

The study is a multicenter open-label, dose escalation, Phase 1b safety and tolerability study in patients with liver metastases of solid tumor of epithelial origin, or primary advanced hepatic carcinoma for which standard therapy has failed or does not exist.  The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBL0102.  Secondary objectives of the study include describing the safety profile, pharmacokinetics, and response to CBL0102.

The study includes a dose escalation arm of up to 30 patients divided into five cohorts, with an additional six patients to be enrolled at the selected therapeutic dose.  Patients will be treated with CBL0102 for eight weeks, with a loading dose administered in week 1 and maintenance doses administered in weeks 2-8.  Dose escalation will be done gradually, starting with a loading dose of 300mg and a maintenance dose of 100mg.  Recruitment is anticipated to take approximately six months, with overall duration of the study to last approximately 12 months.

The lead center for the study is the Russian Oncological Scientific Center (ROSC) in Moscow, a leading oncology center in Russia.  The national coordinator for the study is Professor S.A. Tyulyandin, MD, D.Sc., Deputy Director of Clinical Oncology and Director of Clinical Pharmacology and Chemotherapy at ROSC.

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