Cleveland BioLabs to Submit Protectan CBLB502 for BARDA BAA for Development of Therapies to Protect Civilian Population From Radiation Exposure

Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that it will submit Protectan CBLB502 for the Broad Agency Announcement (BAA) soliciting research and development proposals for "Therapies for Hematopoietic Syndrome, Bone Marrow Stromal Cell Loss, and Vascular Injury Resulting from Acute Exposure to Ionizing Radiation" published on March 6, by the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS).

BARDA seeks to acquire developed medical countermeasures that will be clinically useful in a civilian medical emergency situation that results from or involves exposure of a large population to the effects of a nuclear detonation, a radiologic dispersive device (such as a dirty bomb), or exposure to radioactive material with or without combined injury or trauma. Among certain other criteria, the BAA specified that any medical countermeasures submitted must be efficacious when administered at or later than 24 hours after exposure.

Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs stated, "Our recent contract award from the Department of Defense (DoD) and the BARDA BAA emphasize the government's focus on acquiring adequate protection against nuclear and radiation threats for military and civilian populations. Upon FDA approval, Cleveland BioLabs's Protectan CBLB502 will be well positioned to fulfill both of these needs, with its demonstrated unprecedented efficacy and survival benefits, unique ability to address both hematopoietic and gastrointestinal damage, broad window of efficacy relative to radiation exposure, and suitability for both military and civilian delivery scenarios. Protectan CBLB502 is the only radiation countermeasure with these capabilities in advanced development that can be self or buddy-administered, without the need of additional supportive care in a battlefield or civilian community setting."

"We are actively partnering with both the DoD and HHS to advance development of Protectan CBLB502 and are progressing towards our goal of submission to the FDA for approval in acute radiation syndrome (ARS) for biodefense within the next two years," continued Dr. Fonstein. "If successful in achieving FDA approval, we believe the potential market for Protectan CBLB502 among U.S. government entities alone is quite significant, not to mention other countries facing even more imminent threats. The DoD stated an initial requirement of up to 1.5 million doses of a self or buddy-administered countermeasure for use in the battlefield in its final amendment to last year's RFP. With an estimated minimum selling price for Protectan CBLB502 in the range of $200-$300 per dose, depending on volume, this would represent an initial potential market of over $300 million with just one customer. In addition, the HHS opportunity substantially expands this potential market, as its mandate is to protect the U.S. civilian population in the event of a radiological emergency, involving stockpiling of radiation countermeasures for mass distribution."

The BARDA BAA called for medical countermeasures with one or more of the following three abilities:

--  Replenish the normal hematopoietic (blood/immune) profile, in whole or
    in part following acute radiation exposure that induces lethal
    hematopoietic disorder.

--  Replenish bone marrow niche and progenitor cells that normally
    populate the marrow stroma and niche environment and that can, following
    acute exposure to ionizing radiation that induces lethal hematopoietic
    disorder, restore normal functioning hematopoietic cell lineages.

--  Address injury to the vascular system induced following acute exposure
    to ionizing radiation.

Recently published primate studies have demonstrated the efficacy of Cleveland BioLabs's Protectan CBLB502 as a mitigator of hematopoietic damage up to 48 hours post radiation exposure. At 6.5 Gy doses, 67% of CBLB502-treated animals survived, compared to 25% of the control group when CBLB502 was administered as a single injection at 48 hours post-exposure. Per the BAA's requirement, administration of CBLB502 48 hours post exposure increased survival and had a significantly beneficial effect on platelet levels, while also reducing the severity of radiation-induced neutropenia. These results were obtained using a non-human primate model, the most reliable model when the use of humans is unethical.

Cleveland BioLabs intends to submit a proposal for Protectan CBLB502 for replenishment of normal hematopoietic profile to BARDA. CBLB502 is a bio-engineered derivative of a microbial protein that reduces injury from acute stresses by mobilizing several natural cell protecting mechanisms, including inhibition of programmed cell death (apoptosis), reduction of oxidative damage and induction of regeneration promoting cytokines. Potential medical applications for CBLB502 include reduction of radiotherapy or chemotherapy side effects in cancer patients.