Department of Defense Defense Threat Reduction Agency Increases Development Contract With Cleveland BioLabs for Entolimod(TM) (CBLB502)
BUFFALO, N.Y., Oct. 4, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (CBLI) today announced that it received a $770,442 increase under the Company's existing contract with the U.S. Department of Defense (DoD) Defense Threat Reduction Agency (DTRA) that was initially awarded on January 10, 2011. It is anticipated that the additional funds will be used for development activities for Entolimod" as a medical radiation countermeasure.
Michelle Ross, DVM, M.S, Ph.D., Senior Vice President of Public Health and Government Services for Cleveland BioLabs, commented, "We are very pleased to have additional funding support from the DoD to conduct critical path mechanistic studies to advance Entolimod" towards licensure. There is currently no U.S. Food and Drug Administration (FDA) approved countermeasure for high levels of radiation exposure. The development activities sponsored by this contract support our collaborative efforts to address this unmet need and advance Entolimod" towards a Biologics License Application."
The Company recently 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.
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.