BUFFALO, N.Y., Oct. 1, 2012 (GLOBE NEWSWIRE) -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced the receipt of the End-of-Phase II meeting minutes (the "Minutes") and an Advice Letter providing further clarification on the remaining clinical study protocols for the development of Entolimod™ (CBLB502) as a radiation countermeasure from the U.S. Food and Drug Administration (the "FDA").
The Minutes reiterated the FDA's commitment to moving the Entolimod™ program forward and summarized the Agency's responses and requests regarding several aspects of the Company's proposed plan for dose conversion, as discussed during the meeting and in related correspondence.
The Advice Letter provided specific guidance on the structure of the remaining clinical studies, including two primary study outcomes: generation of additional biomarker information for dose conversion as an initial study focus and then subsequent generation of extended safety data using the projected efficacious dose defined by the initial dose conversion study. The letter also provided specific recommendations on several technical aspects of the Company's proposed clinical protocol that remain in active and ongoing discussion.
Yakov Kogan, Ph.D, MBA, Chief Executive Officer of Cleveland BioLabs, stated, "This correspondence represents a significant step forward in delineating the path forward for Entolimod™ and we continue to be pleased by our interactions with the FDA. We believe that the receipt of the Minutes and feedback on our clinical program, along with our previously announced agreements on the pivotal animal program enable us to continue funding discussions with our government agency partners."
The Company previously announced the receipt of an Advice Letter from the FDA indicating agreement with the design of the proposed pivotal animal efficacy studies and accepting the Company's recently concluded Good Laboratory Practice non-human primate study as part of the pivotal program.
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.
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.
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|