Contact Information: Contacts: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Protectan CBLB502 Demonstrates Strong Mitigation Of Hematopoietic Damage at 48 Hours Post-Exposure to 6.5 Gy of Radiation
Highlights Broad Agency Announcement From BARDA for Development of Therapies for Acute Exposure to Ionizing Radiation
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - March 31, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that recent 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.
Protectan CBLB502 was administered as a single injection at 48 hours
post-exposure to 6.5 Gy doses of ionizing radiation, which results in
approximately 75% mortality, if untreated (similar to doses received by
Chernobyl firefighters). In the non-human primate model tested,
approximately 67% of the Protectan CBLB502-treated animals survived
compared to 25% of the control group. Administration of CBLB502 48 hours
post exposure was shown to increase survival, and have a significantly
beneficial effect on platelet levels while also reducing the severity of
radiation-induced neutropenia.
Protection of civilian populations and war-fighters is of high current
interest to both the Department of Health and Human Services (HHS) and the
Department of Defense (DoD). On March 6, 2008 the Biomedical Advanced
Research and Development Authority (BARDA), a Department of HHS, published
a 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."
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.
The BAA anticipates the award of 5 to 6 three-year contracts, each valued
at $3 to $5 million annually, to be made on or about September 16, 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's Protectan CBLB502 has the ability to replenish normal
hematopoietic profile in non-human primates, as demonstrated by recent
experiments. CBLB502 is a 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.
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.