Cleveland BioLabs Attains Orphan Drug Status From the EMA for Entolimod as a Radiation Countermeasure

BUFFALO, NY--(Marketwired - Jan 21, 2016) - Cleveland BioLabs, Inc. (NASDAQ: CBLI), today announced that entolimod has been granted orphan drug status by the European Medicines Agency (EMA) for treatment of acute radiation syndrome. Acute radiation syndrome comprises serious bone marrow, gastrointestinal, and other toxicities arising from exposure to high doses of radiation.

In order to qualify for orphan drug designation with the EMA, a drug must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the EU must not be more than 5 in 10,000 people; no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

Sponsors who obtain orphan designation benefit from a number of incentives, including: protocol assistance, scientific advice, market exclusivity once the medicine is on the market, and reductions in certain fees. 

Yakov Kogan, PhD, MBA, Chief Executive Officer of Cleveland BioLabs, commented, "We are excited to be initiating a regulatory process with the EMA for entolimod as a radiation countermeasure. We believe entolimod can offer an effective treatment for people who have been exposed to potentially life-threatening radiation as the result of a radiation accident or nuclear attack. We are dedicated to making the drug commercially available for the benefit of Europeans in case of a radiation emergency."

The U.S. Food and Drug Administration previously granted orphan drug status to entolimod for prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster.

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 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. 

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