BUFFALO, N.Y., Oct. 25, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that the U.S. Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) refocused existing contract funding to support critical path studies on non-human primate (NHP) subjects needed for U.S. Food and Drug Administration (FDA) licensure of Entolimod™ as a radiation countermeasure. This effort represents approximately $1.5 million of development funding under the Company's existing development contract, which includes an up to $30 million purchase option and was awarded on September 16, 2010.
Yakov Kogan, Ph.D, MBA, Chief Executive Officer of Cleveland BioLabs, commented, "We believe that the flexibility shown by CBMS to reallocate these funds demonstrates the U.S. government's belief these studies will be beneficial to the development of Entolimod™. We are pleased by our continuing progress with the FDA on finalizing remaining requirements for a Biologics License Application, which was influential in facilitating the contract modification. The CBMS modification will assist us in performing at least one of the necessary pivotal animal studies. Our objective is to advance Entolimod™ to licensure under the FDA's Animal Rule as soon as possible, and position it for potential acquisition in the U.S. and globally."
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.
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