April 9, 2008
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.
According to the BAA, it is anticipated that multiple awards will result from the announcement and those awards will be multi-year, cost-reimbursement, completion type contracts. BARDA anticipates awarding 5-6 contracts on or about September 16, 2008. The HHS/BARDA estimates that the total cost (direct and indirect cost combined) for these contracts (estimate to be 3 years in duration) will be up to $13.5 million per contract, out of which up to $3.4 million will be available in fiscal year 2008.
The BARDA BAA may be accessed from the following URL: http://www.fbo.gov/spg/HHS/OOS/OASPHEP/BAA%2DBARDA%2D08%2D08/listing.html.
Cleveland BioLabs has successfully established cGMP quality manufacturing for CBLB502 and plans to initiate its first Phase I safety study for Protectan CBLB502 in healthy volunteers for the indication of ARS in the first half of 2008. The ARS indication follows an abbreviated approval pathway through the FDA's two-animal rule, which requires efficacy in two species and only safety in humans. This makes the start of the first Phase I in ARS especially important and although it will need to be followed with a much larger cohort of volunteers prior to submission for FDA approval, this initial trial will provide indications of human safety and therapeutic efficacy, through the identification of predicted changes in certain cytokines, which function as biomarkers.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company leveraging its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses. The Company has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research 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. Some of the factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the "Risk Factors" described in the Company's periodic filings with the Securities and Exchange Commission.
Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: [email protected]
SOURCE: Cleveland BioLabs, Inc.