Contact Information: Company Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com Media Contact Ivette Almeida Global Consulting Group T: (201) 232-0128 E: ialmeida@hfgcg.com
Department of Defense Awards Cleveland BioLabs Contract to Develop Protectan CBLB502
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - April 3, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that the Department of Defense (DoD) has awarded the Company a
letter contract through the Chemical Biological Medical Systems (CBMS)
Joint Project Management Office Broad Agency Announcement
(http://www.jpeocbd.osd.mil/page_manager.asp?pg=2&sub=66) for selected
tasks in the advanced development of Protectan CBLB502 as a Medical
Radiation Countermeasure to treat radiation injury following exposure to
radiation from nuclear or radiological weapons. A letter contract is a
written preliminary contractual instrument that authorizes initial
performance prior to negotiating a definitized contract. When definitized,
this contract shall not exceed $8.9 million in development funding.
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland
BioLabs stated, "The DoD's funding of Protectan CBLB502 reflects their
evaluation of its potential safety and efficacy as a medical radiation
countermeasure and recognition of its potential suitability for the armed
forces' needs on the battlefield. We are pleased to be working for CBMS,
which rapidly provides the Warfighter with safe, robust, affordable medical
countermeasures against the broad spectrum of CBRN threats. We hope that
Protectan CBLB502, when approved by the FDA, will offer a practical
solution for one of the deadliest threats that exists in today's world."
"We have collaborated closely with the Armed Forces Radiobiology Research
Institute on development of Protectan CBLB502 for several years and believe
its unique abilities to mitigate both hematopoietic and gastrointestinal
effects of ionizing radiation as well as demonstrate significant survival
benefits are well suited to the DoD's requirements," continued Dr.
Fonstein. "Moreover, we believe the compound's safety profile, stability,
method of administration and cost effectiveness, make it highly practical
for field deployment. We believe Protectan CBLB502, with its potential to
protect both military and civilian populations, will play a significant
role in domestic and global biodefense preparedness."
Colonel David Williams, Joint Project Manager, CBMS, commented: "CBMS uses
Government and commercial best practices to acquire FDA-approved CBRN
medical countermeasures and diagnostics. CBMS protects the Warfighter by
maintaining uncontested global supremacy in CBRN medical countermeasure
development and delivery. CBMS is pleased to contribute to Cleveland
BioLabs' advanced development of Protectan CBLB502, which is a promising
drug candidate for the Joint requirements of the DoD. Preliminary data
suggests that Protectan CBLB502 is safe and efficacious in animals, is
suitable for use on the battlefield or following evacuation, and has a
manageable logistics burden."
Protectan 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. Cleveland BioLabs plans to initiate a Phase I human
safety trial in the first half of 2008 for Protectan CBLB502 in Acute
Radiation Syndrome. Subsequently, Phase II expanded clinical safety trials
and definitive animal efficacy studies are planned in support of FDA
approval using the "Animal Rule." The FDA's "Animal Rule" provides an
alternate path for the approval or licensure of drugs and biologics, which
cannot ethically be tested definitively for efficacy in human volunteers.
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.