BUFFALO, NY--(Marketwired - Oct 11, 2016) - Cleveland BioLabs, Inc. (
The modification changes the original statement of work of the contract by eliminating certain tasks no longer deemed critical for the preparation of a Biologics License Application (BLA) of entolimod as a radiation countermeasure and establishes new tasks to address questions raised by the Food and Drug Administration (FDA) including an aim to conduct a pharmacokinetic/pharmacodynamic (PK/PD) biocomparability study in a nonhuman primate (NHP) model (the Biocomparability Study) along with other drug manufacturing related activities.
The objective of the Biocomparability Study is to compare the historical drug formulation used in prior pre-clinical and clinical studies versus the to-be-marketed drug product lots of entolimod submitted for approval under CBLI's application for pre-Emergency Use Authorization (pre-EUA). Entolimod is a novel, broad-spectrum investigational drug being developed to mitigate the life-threatening consequences of a radiological attack.
Because this contract modification involves replacement of certain tasks that cost in excess of tasks being eliminated, the aggregate amount of consideration payable to CBLI by the DoD will be unaffected.
Yakov Kogan, Ph.D., Chief Executive Officer for Cleveland BioLabs, stated, " We are pleased that the DoD program management office remains engaged and flexible to make this critical and value-added contract modification."
The mention of any specific companies, commercial products, processes, or services by trade name, trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement, recommendation, or favoring by the United States Government. The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, oncology immunotherapy, and vaccines. The company's most advanced product candidate is entolimod, which is being developed for a biodefense indication and as an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC and a joint venture with OJSC Rusnano, Panacela Labs, Inc. 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 certain forward-looking information about Cleveland BioLabs, Inc. 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 do not relate strictly to historical or current facts. Words and phrases such as "potential," "may," "future," "will," "plan," "anticipate," "believe," "intend" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the company's future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals or the impact of any laws or regulations applicable to the company, and plans and objectives of management for future operations. 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 factors include, among others, the risks inherent in the early stages of drug development and in conducting clinical trials; the company's plans and expectations with respect to future clinical trials and commercial scale-up activities; the company's ability to attract collaborators with development, regulatory and commercialization expertise and the financial risks related to those relationships; the company's ability to comply with its obligations under license agreements; the company's inability to obtain regulatory approval in a timely manner or at all; the commercialization of the company's product candidates, if approved; the company's plans to research, develop and commercialize its product candidates; future agreements with third parties in connection with the commercialization of any approved product; the size and growth potential of the markets for the company's product candidates, and its ability to serve those markets; the rate and degree of market acceptance of the company's product candidates; 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; regulatory developments in the United States and foreign countries; the performance of the company's third-party suppliers and manufacturers; and the success of competing therapies that are or may become available. 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.