SOURCE: Cleveland BioLabs, Inc.

Cleveland BioLabs, Inc.

September 29, 2010 10:44 ET

Cleveland BioLabs Announces Results of Second Safety Study for CBLB502

BUFFALO, NY--(Marketwire - September 29, 2010) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced top line results of the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome (ARS).

This second safety study included a total of 100 healthy subjects randomized among four dosing regimens of CBLB502, comparing a narrow range of doses applied as single or double injections (72 hours apart), with or without ibuprofen. Participants in the study were monitored for adverse side effects and blood samples were obtained to assess the effects of CBLB502 on various biomarkers and to further characterize the pharmacokinetics of CBLB502. 

Top line results of the study demonstrated a difference in biomarker response proportional to the dose applied as single intramuscular injections of CBLB502. The demonstration of such a dose difference was the primary goal of the trial. This information will be used in the design of the definitive safety trial following further discussions with the U.S. Food and Drug Administration (FDA).

Administration of CBLB502 resulted in a rapid and potent cytokine response, similar to that seen in the prior clinical trial and in previously conducted non-human primate studies. Single and double doses of CBLB502 were well tolerated. The primary adverse event associated with CBLB502 administration was a transient flu-like syndrome consistent with what was observed in the previous trial and which generally resolved within 24 hours. There was no difference in the adverse event profile between the doses tested.

Subjects who carry a single mutation in the TLR5 gene, the target of CBLB502, which is found in about 5% of the general population, responded to CBLB502 in the same manner as normal subjects without the mutation. 

Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs, commented, "We are very pleased with the outcome of our second human safety study for CBLB502. The study met its objectives and has confirmed that the general side effect and biomarker profile for CBLB502 remains consistent with what was observed in our initial safety study. We will be conducting further analysis as we compile our final report for submission to the FDA, and once completed, we will prepare a manuscript describing the results of the study for submission to an appropriate scientific journal."

In July 2010, CBLB502 was granted fast track status from the FDA for reducing the risk of death following total body irradiation during or after radiation disaster. There is currently no FDA approved medical countermeasure to reduce the risk of death following a lethal dose of total body irradiation.

The Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services supported the entire cost (approximately $1.3 million) of this clinical Phase 1b human safety study as part of contract HHSO100200800059C.

About CBLB502
CBLB502 is a derivative of a microbial protein that potentially reduces injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration-promoting cytokines. 

CBLB502 is being developed by Cleveland BioLabs under the FDA's Animal Efficacy Rule to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human volunteers. 

Evidence of CBLB502's mechanism of action and activity in animal models was published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp. 226-230). Data from 50 human subjects in an initial Phase I safety and tolerability study indicated that CBLB502 was well tolerated and that normalized biomarker results corresponded to previously demonstrated activity in animal models of ARS. 

About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries around programmed cell death to develop treatments for cancer and protection of normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation 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.

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; 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 Information

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