Cell Reports Publication Elucidates Role of FACT as Accelerator of Tumor Transformation and Potential Marker and Target of Aggressive Cancers

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| Source: Cleveland BioLabs, Inc.

BUFFALO, N.Y., July 8, 2013 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI), Incuron, LLC, a joint venture between CBLI and Bioprocess Capital Ventures, and Roswell Park Cancer Institute (RPCI) today announced the publication of studies describing the Facilitates Chromatin Transcription (FACT) complex as an accelerator of tumor transformation and a potential marker and target for aggressive cancers in Cell Reports, a peer-reviewed journal. FACT is the molecular target for Curaxins, a new class of anti-cancer compounds being developed by Incuron. The reported studies were led by scientists at RPCI.

The FACT complex is involved in chromatin remodeling during transcription, replication, and DNA repair.  These studies confirm an association between FACT and cancer by showing that FACT is expressed at higher levels in tumor cell lines than in normal cells in vitro and that elimination of FACT expression leads to reduced growth and decreased survival of tumor cells.  The published work concludes that FACT's role in cancer likely involves selective chromatin remodeling of genes that stimulate proliferation, inhibit cell death and differentiation, and regulate cellular stress responses, making it an enabler of oncogene-induced transformation.

In addition, the studies establish a statistically significant association between the frequency and level of FACT expression and tumor aggressiveness. The studies demonstrated that FACT is predominantly expressed in aggressive undifferentiated cancers that result in poor overall patient survival because of the development of metastatic disease, irrespective of tumor size at the time of diagnosis.  This increases the potential value of FACT as a prognostic marker, as FACT positivity of a primary tumor could be used at a very early stage to determine the risk of future metastatic disease.

"This recent publication builds upon our previous work showing that FACT is the molecular target of Curaxins," noted Katerina Gurova, M.D., Ph.D., a researcher in the Department of Cell Stress Biology at RPCI and lead author.  "The data presented in the Cell Reports publication indicate that FACT is a promising marker and target for subtypes of cancer characterized by high grade and aggressiveness, and poor prognosis. This, together with the absence of FACT expression in most normal tissues, suggests that pharmacological inhibition of FACT using Curaxins could be an effective strategy to treat types of cancer for which there are currently few treatment options."

Jean Viallet, M.D., Chief Development Officer at Cleveland BioLabs, stated, "We are evaluating the enormous body of data collected by our collaborators on FACT expression and its role in cancer progression in an effort to focus our next trials with our lead Curaxin drug candidate, CBL0137. Our plan is to enrich the upcoming study of the intravenous administration of CBL0137 in patients with metastatic or unresectable advanced solid tumors and lymphomas by including patients whose tumor types are dependent on transcriptional oncogenes."

In March 2013, a Notice of Allowance was received from the U.S. Food and Drug Administration for an Investigational New Drug Application for intravenous administration of CBL0137.  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.

The Cell Reports publication may be found online at: http://cellreports.cell.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.

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 Roswell Park Cancer Institute:

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on Facebook and Twitter.

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 develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; the conduct and results of our various clinical trials; financial projections and estimates and their underlying assumptions; 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 failure to successfully and timely develop new products; the Company's collaborative relationships and the financial risks related thereto; the Company's ability to comply with its obligations under license agreements; 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 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. 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.

Contacts:
Rachel Levine, Vice President, Investor Relations 
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com
 
Annie Deck-Miller, Senior Media Relations Manager
Roswell Park Cancer Institute
T: (716) 845-8593
E: annie.deck-miller@roswellpark.org