BUFFALO, NY--(Marketwired - Apr 14, 2015) - Cleveland BioLabs, Inc. (
This proposal application aims to conduct an additional clinical study to support submission of a Biological Licensure Application (BLA) to the U.S. Food and Drug (FDA). Entolimod is a novel investigational drug that addresses the Department of Defense concern against radiological threats.
Yakov Kogan, Ph.D., Chief Executive Officer for Cleveland BioLabs, stated, "We are grateful for the continued support of the Department of Defense for entolimod's development as a broad spectrum medical readiation countermeasure. We believe entolimod offers a viable solution to protect our military personnel and civilians from the potentially deleterious effects of ionizing radiation and hope to contribute to our nation's preparedness."
In January, CBLI announced receipt of notice that a proposal supporting several pivotal animal efficacy studies to support submission of a BLA to the FDA was recommended for funding, subject to negotiations by the DoD office of CDMRP. Negotiations regarding that proposal are ongoing.
In September 2014, the Company announced that the minutes from its meeting with the 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 submission for entolimod for reducing the risk of death following exposure to potentially lethal irradiation occurring as the result of a radiation disaster.
A pivotal efficacy study conducted in 179 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. 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 a Phase 1 study.
About Cleveland BioLabs, Inc. 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 most advanced product candidate is entolimod, which is being developed for a biodefense indication and as a potential cancer treatment. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and through two joint ventures, Panacela Labs, Inc. and Incuron, LLC. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer 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 potential that the Company is unable to successfully negotiate the funding of entolimod with the DoD or that the DoD will decline to provide funding due to lack of funds or other reasons; 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 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 failure to successfully and timely develop new products; 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; the Company's ability to comply with various safety, environmental and other governmental regulations; 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; and the Company's need for substantial additional financing to meet its business objectives. 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.
Contact: Rachel Levine Vice President, Investor Relations Cleveland BioLabs, Inc. T: (917) 375-2935 E: rlevine@cbiolabs.com
