Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs to Respond to Department of Defense Request for Proposal for Radiation Countermeasure
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - January 12, 2010) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that it intends to respond to a Request for Proposal (RFP)
recently issued by The Department of Defense (DoD) for the advanced
development, Food and Drug Administration (FDA) approval/licensure and
delivery of Medical Radiation Countermeasure (MRC).
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland
BioLabs, stated, "The issuance of this RFP is tremendously positive, as it
confirms the DoD's continued interest and investment in licensure and
procurement of a MRC. We are excited by the opportunity to submit CBLB502
as a candidate for this contract award and to expand upon CBLI's existing
relationships with the DoD and other federal agencies. We believe CBLB502
has many of the properties targeted by the RFP and we have made great
strides in advancing CBLB502 towards submission for FDA licensure."
As stated in the RFP, the ultimate goal of the MRC Project is to select,
develop, and manufacture a FDA-approved drug/biologic to increase survival
and decrease incapacity such that forces can maintain operational
effectiveness within a contaminated area following radiation exposure.
The solicitation will specifically seek a drug/biologic intended for use
following exposure to ionizing radiation to prevent/reduce the extent of
radiation injury, specifically targeting the gastrointestinal (GI) tract.
Further, the candidate must be safe and efficacious when administered at
least 4 hours following the radiation exposure and have a minimal
logistical burden in terms of storage, delivery and administration.
Potential candidates must submit data demonstrating safety in humans and
efficacy in animal models as required to obtain an FDA license under the
Animal Rule. A further requirement is evidence of progress toward achieving
current Good Manufacturing Practices (cGMP) compliance as part of their
technical proposal. Contract options will result in purchase and delivery
of products to meet the initial requirements established by the DoD in
order to protect service members exposed to ionizing radiation.
The Department of Defense's RFP may be publicly accessed from the following
URL: http://www.jpeocbd.osd.mil/packs/Default.aspx?pg=1214&title=CBMS%20-%20Current%20Opportunities
Responses to the RFP are due by February 17, 2010.
About CBLB502
CBLB502 is a derivative of a microbial protein, which has demonstrated the
capacity to reduce injury from acute stresses, such as radiation in animal
models. CBLB502 mobilizes several cell protective mechanisms, including
inhibition of programmed cell death (apoptosis), reduction of oxidative
damage and induction of regeneration-promoting cytokines.
CBLB502 is being developed under the U.S. Food and Drug Administration's
Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation
poisoning from any exposure to radiation such as a nuclear or radiological
weapon/ dirty bomb, or from a nuclear accident. This approval pathway
requires demonstration of efficacy in representative animal models and
safety and drug metabolism testing in healthy human volunteers.
Evidence of CBLB502's mechanism of action and activity in animal models was
published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp.
226-230). Data from 50 subjects in an initial Phase I safety and
tolerability study indicated that CBLB502 was well tolerated and that
normalized biomarker results corresponded to previously demonstrated
activity in animal models of ARS. There is currently no FDA approved
medical countermeasure to treat ARS.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company
leveraging its proprietary discoveries around programmed cell death to
develop treatments for cancer and protection of 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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission on March 30, 2009.