BUFFALO, N.Y., Oct. 10, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced that the first patient was dosed in a Phase 1, single agent, dose escalation study of the oral formulation of CBL0137 in subjects with advanced solid tumors that are resistant or refractory to standard of care treatment.
The trial is being conducted at five leading oncology centers in the Russian Federation. The primary objective of the study is to determine the maximum tolerated dose and dose limiting toxicity in patients receiving CBL0137. Secondary objectives of the study include describing the safety profile, pharmacokinetics, and tumor response to CBL0137. 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. 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.
CBL0137 is a proprietary small molecule with a unique mechanism of action that is in development for oncology applications. A program aimed at developing an intravenous formulation of CBL0137 is ongoing in the United States. A pre-Investigational New Drug Application (IND) meeting was conducted over the summer with the U.S. Food and Drug Administration in anticipation of filing an IND in the first quarter of 2013.
About Incuron, LLC
Incuron, LLC is a Russian Federation based joint venture founded in 2010 between Russian Closed Mutual Venture Fund "Bioprocess Capital Ventures," and Cleveland BioLabs. Incuron is developing CBL0102 and CBL0137 for oncology and orphan indications. To learn more about Incuron, LLC, please visit the company's website at http://www.incuron.com/.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a clinical-stage biotechnology company leveraging deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury. The Company's lead compound is being developed as both a radiation countermeasure and a cancer treatment. The Company has two operating subsidiaries, Incuron, LLC, and Panacela Labs, Inc., and strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, the Children's Cancer Institute Australia and the Armed Forces Radiobiology Research Institute. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors.
These factors include, among others, the Company's history of operating losses and the potential for future losses, which may lead the Company to not be able to continue as a going concern; the Company's need for substantial additional financing to meet its business objectives; the potential for the loss of funding from the Company's R&D grants and contracts and its ability to win additional funding under such grants and contracts; the Company's failure to successfully and timely develop new products; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; the potential for significant product liability claims; and the Company's ability to comply with various safety, environmental and other governmental regulations. Some of these factors could cause future results to materially differ from the recent results or those projected in forward-looking statements. See also the "Risk Factors" and "Forward-Looking Statements" described in the Company's periodic filings with the Securities and Exchange Commission.