Cleveland BioLabs Announces Publication of Studies Identifying Biomarkers of CBLB502's Efficacy as a Radiation Countermeasure

Definition of Biomarkers Key to Animal Rule Development

BUFFALO, N.Y., Aug. 1, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced the online publication of studies identifying biomarkers of CBLB502's efficacy as a radiation countermeasure in the Journal of Pharmacology and Experimental Therapeutics, a leading peer-reviewed research journal in the field of pharmacology. The reported studies were conducted by scientists of Cleveland BioLabs in collaboration with researchers at the Armed Forces Radiobiology Research Institute and the F. Edward Hebert School of Medicine at the Uniformed Services University of the Health Sciences, and Roswell Park Cancer Institute.

CBLB502 is a Toll-like receptor 5 (TLR5) agonist currently under development as a radiation countermeasure. Development for this indication is guided by the U.S. Food and Drug Administration's (FDA) Animal Rule, one requirement of which is data or information on the kinetics and pharmacodynamics of the product or other relevant data that will allow projection of human efficacious doses from animal efficacy data.

The published work identified two cytokines, granulocyte colony-stimulating factor (G-CSF) and interleukin-6 (IL-6), as biomarkers of CBLB502 efficacy that satisfy the conditions set by the FDA for this aspect of the Animal Rule. Findings relevant to these required conditions include: (i) for both G-CSF and IL-6, induction by
CBLB502 was shown to be strictly drug target (TLR5)-dependent and dependent on the dose of CBLB502 administered, (ii) G-CSF and IL-6 were strongly induced by CBLB502 within its efficacious dose range in both non-irradiated and irradiated mammals, (iii) the identified biomarkers were found to be critically important for the ability of CBLB502 to rescue irradiated animals from death, and (iv) G-CSF and IL-6 can be readily measured in humans using validated assays. Notably, the majority of the reported studies were conducted in non-human primates (NHP), the animal model of acute radiation syndrome closest to humans.

Andrei Gudkov, Ph.D., D.Sci., Chief Scientific Officer of Cleveland BioLabs, Senior Vice President of Basic Science at Roswell Park Cancer Institute and corresponding author of the paper, commented:
"Identification of biomarkers for CBLB502 represents a key step along the critical development path for CBLB502 as a radiation countermeasure. Our ability to define efficacy biomarkers for CBLB502 reflects a greater understanding of the drug's mechanism of action and builds a more solid platform for determination of the human efficacious dose of CBLB502. Several publications have highlighted the individual radioprotective effects of G-CSF and IL-6. The ability of our drug to induce both of these cytokines partially explains its potency as a radiation antidote."

Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance for Cleveland BioLabs, stated, "Identification of efficacy biomarkers is one of the key elements of our strategy for accurately predicting the human efficacious doses of CBLB502, an important step in its development as a radiation countermeasure. We have submitted the results of the major experiments that formed the basis for this paper to the FDA, and as previously reported, have received concurrence from the agency that these biomarkers do play important roles in the mechanism of CBLB502-induced radioprotection."

The work reported in the publication was funded by the US Department of Defense (DoD) Defense Threat Reduction Agency; the US DoD Chemical Biological Medical Systems; the US Department of Health & Human Services Biomedical Advanced Research and Development Authority; and the National Institute of Allergy and Infectious Diseases of the US National Institutes of Health.

"This publication is an indication of the success of an ongoing collaboration between CBLI and the Armed Forces Radiobiology Research Institute in developing new radiation countermeasures," added Dr.
Gudkov. "Sponsorship of these studies by government funding agencies responsible for radiation countermeasure development emphasizes the significance of biomarker identification to the Animal Rule."

The Company recently announced survival results for its randomized, blinded, placebo-controlled efficacy study of CBLB502 in 179 NHPs conducted under Good Laboratory Practice with elements of Good Clinical Practice, as required by the FDA's Animal Rule. This study demonstrated with a high degree of statistical significance that a single dose of
CBLB502 given 25 hours after exposure of Rhesus macaques to a 70% lethal dose of total body irradiation improved animal survival by nearly three-fold compared to control. Dose-dependence of CBLB502's efficacy was demonstrated with doses above the minimal efficacious dose establishing a plateau at approximately 75% survival at 60 days after irradiation, as compared to 27.5% survival in the placebo-treated group.

The Journal of Pharmacology and Experimental Therapeutics publication may be found online at:
http://jpet.aspetjournals.org/content/early/recent

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.
 

Posted: August 2012

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