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Cleveland BioLabs And Incuron Announce Notice Of Allowance From FDA To Commence Clinical Testing With CBL0137

Stocks in this article: CBLI

BUFFALO, N.Y., April 2, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) and Incuron, LLC, a joint venture between the Company and Bioprocess Capital Ventures, 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.

A multi-center, Phase 1, single agent, dose escalation trial evaluating intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid cancers is being finalized with the FDA. 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.

A Phase 1, single agent, dose escalation study of oral administration of CBL0137 in patients with advanced solid tumors that are resistant or refractory to standard of care treatment is ongoing in the Russian Federation.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer of CBLI, commented, "We are pleased to announce the opening of an IND for CBL0137 in the U.S. Our recently expanded knowledge regarding FACT expression in tumors and the potential ability to obtain additional data on CBL0137's impact on FACT expression through initial trials in US and Russia will be invaluable as we plot the future clinical development of CBL0137."

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 .

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/ .

This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully obtain regulatory approval for our therapeutic product candidates; statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; the conduct and results of our various clinical trials; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. 

These factors include, among others, the Company's inability to obtain regulatory approval in a timely manner or at all; the Company's failure to develop new products; the Company's collaborative relationships and the financial risks related thereto; the risks inherent in the early stages of drug development and in conducting clinical trials. 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, Vice President, Investor Relations Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com

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