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Cleveland BioLabs And Incuron Announce CBL0102 Orphan Drug Status For Hepatocellular Carcinoma

BUFFALO, N.Y., Oct. 2, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, today announced that curaxin CBL0102 (quinacrine) has been granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for treatment of hepatocellular carcinoma.

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.

There are approximately 30,000 U.S. and 45,000 E.U. annual cases of hepatocellular carcinoma, with an overall survival rate of approximately 15%.

CBL0102 is an orally administered small molecule that acts by blocking activity of chromatin remodeling complex FACT, resulting in simultaneous modulation of three signal transduction pathways (p53, NF-kappaB and heat shock response) commonly deregulated in cancer.

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 .

The Cleveland BioLabs, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11668

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.

Contact:
Rachel Levine, Director Investor Relations & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com

Cleveland BioLabs, Inc. Logo

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