Cleveland BioLabs Receives FDA Agreement on Pivotal Animal Efficacy Studies for Development of CBLB502 (Entolimod(TM)) as Radiation Countermeasure
BUFFALO, N.Y., Sept. 10, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (CBLI) today announced the receipt of an Advice Letter from the U.S. Food and Drug Administration (FDA) indicating agreement with proposed pivotal animal efficacy studies for the development of CBLB502 (Entolimod") as a radiation countermeasure. The FDA also accepted the Company's recently concluded Good Laboratory Practice non-human primate (NHP) study as part of the pivotal program.
Ann Hards, Ph.D., Executive Vice President of Regulatory Affairs and Quality Assurance for Cleveland BioLabs, stated, "We are encouraged by the multiple agreements outlined in the FDA's correspondence, as well as the prompt nature of their response. We are pleased with both our progress and the constructive nature of our recent interactions, and look forward to receipt of the August End-of-Phase II meeting minutes along with additional feedback on our clinical protocol."
Entolimod" is a therapeutic drug currently in development under the FDA's Animal Rule to reduce the risk of death after total body irradiation. The Animal Rule provides a mechanism for marketing approval when human efficacy studies are not ethical or feasible. Development under the Animal Rule includes efficacy studies in animal models and human safety studies, as well as studies to support the conversion of the effective dose in animals to an effective dose in humans.
In June, the Company announced survival results for its randomized, blinded, placebo-controlled efficacy study of Entolimod" in 179 NHPs conducted under Good Laboratory Practice with elements of Good Clinical Practice, as required by the Animal Rule. This study demonstrated with a high degree of statistical significance that a single dose of Entolimod" given to Rhesus macaques 25 hours after exposure to a 70% lethal dose of total body irradiation improved animal survival by nearly three times compared to the control group. Dose-dependence of Entolimod'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.
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 .
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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.
Rachel Levine, Director Investor Relations & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
Source: Cleveland BioLabs, Inc. 2012 GlobeNewswire, Inc.