BUFFALO, NY -- (Marketwired) -- 09/03/14 -- Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the minutes from its meeting with the U.S. Food and Drug Administration (FDA) in July confirmed that the Company's existing efficacy and safety data and animal-to-human dose conversion are sufficient to proceed with a pre-Emergency Use Authorization (pre-EUA) submission for entolimod for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster.
Yakov Kogan, Ph.D, MBA, Chief Executive Officer of Cleveland BioLabs, stated, "The outcome of our FDA meeting is very positive and we are pleased with the agreements we have reached with the agency. Our achievement of animal-to-human dose conversion and the FDA's acknowledgement of the conceptual soundness of our dose-conversion methods are significant milestones in entolimod's development under the FDA's Animal Rule."
"We are starting preparations for a pre-EUA application which, if authorized, would allow for entolimod's use in the event of a radiological or nuclear emergency. In parallel, we are continuing our discussions with various U.S. government agencies regarding potential co-sponsorship and support for a pre-EUA submission for entolimod, as well as ongoing funding for the remaining development steps required for full licensure. We believe that entolimod has enormous potential to save lives as part of the nation's defense against a radiological or nuclear disaster and are dedicated to moving its development forward."
A pivotal efficacy study conducted in 179 non-human primates (NHPs) demonstrated that a single intramuscular injection of entolimod given 25 hours after high-dose, whole-body irradiation increased survival from 27.5% in control animals to 75% in treated animals -- a highly statistically significant, nearly three-fold improvement. These results were obtained without the use of any antibiotics or supportive care. A second, pivotal dose-conversion study conducted in 160 NHPs established the dose-dependent effect of entolimod on biomarkers for efficacy in non-irradiated NHPs.
Clinical studies of entolimod in 150 healthy human subjects have demonstrated the safety profile of entolimod and established the dose-dependent effect of entolimod on efficacy biomarkers in humans. In addition, entolimod has been administered to 25 patients with advanced cancer in an ongoing Phase 1 study.
The FDA has granted Fast Track status to entolimod and Orphan Drug status for prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.
Conference Call Information
Cleveland BioLabs management will host a conference call at 11:00 a.m. ET today to discuss these developments and address questions. Interested parties may participate by dialing 877-407-9205 (US) or 201-689-8054 (International), approximately five to ten minutes before the call start time. A live webcast of the conference call will be available on the Investors page of the Cleveland BioLabs web site at www.cbiolabs.com. A replay of the call will be available starting on September 3, 2014, at 2:00 p.m. ET through September 17, 2014, at 11:59 p.m. ET. Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering conference ID number 13589652. An archived webcast of the conference call will be available for 90 days on the Investors page of the Cleveland BioLabs web site at www.cbiolabs.com.
About Cleveland BioLabs
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company seeking to develop first-in-class pharmaceuticals designed to address diseases with significant medical need. The company's lead product candidates are entolimod, which is being developed for a biodefense indication and as a potential cancer treatment and Curaxin CBL0137, our lead oncology product candidate. The company conducts business in the United States and in the Russian Federation through our three operating subsidiaries, Incuron, LLC, BioLabs 612, LLC and Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic, Roswell Park Cancer Institute, and the Children's Cancer Institute Australia. To learn more about Cleveland BioLabs, Inc., please visit the Company's website at http://www.cbiolabs.com.
This press release contains certain forward-looking information about Cleveland BioLabs that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "intend," "would allow," "potential" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the safety of entolimod, the ability of entolimod to increase survival rates after irradiation, our ability to successfully develop and commercialize entolimod; the conduct and results of our various clinical trials; our ability to obtain pre-EUA approval from the U.S. Food and Drug Administration for entolimod and subsequent full licensure; our ability to find partnerships and sources of funding to a pre-EUA submission and full licensure; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.
These risks and uncertainties include, among others, the Company's inability to demonstrate the safety and efficacy of entolimod as a radiation countermeasure, the Company's failure to successfully and timely develop entolimod and existing and new products; the Company's inability to obtain EUA approval for entolimod and subsequent full licensure; the Company's collaborative relationships, including the Company's inability to obtain co-sponsorship and financial support for the development of entolimod from U.S. government agencies, and the financial risks related thereto; the risks inherent in the early stages of drug development and in conducting clinical trials; the Company's ability to comply with its obligations under license agreements; 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. 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.