BUFFALO, NY--(Marketwire - May 28, 2009) - Cleveland BioLabs, Inc. (
NASDAQ:
CBLI) today
announced that it has responded to the Sources Sought Notice issued on May
5, 2009 by the Department of Defense (DoD) to identify interested companies
that have the capability to develop and manufacture specifically identified
Chemical, Radiological and Nuclear (CRN) therapeutics.
According to the Sources Sought Notice, the Chemical Biological Medical
Systems Medical Identification and Treatment Systems Joint Product
Management Office (CBMS-MITS JPMO) of the DoD is seeking identification of
sources having the capability to develop, through FDA approval and
production, the following CRN therapeutics:
- An aerosolized atropine drug delivery system to treat lingering
effects of nerve agent intoxication related to muscarinic stimulation;
- A radiological/nuclear therapeutic medical countermeasure to be
administered following exposure to ionizing radiation that will decrease
incapacity and prolong survival by treating the gastrointestinal
sub-syndrome of Acute Radiation Syndrome (ARS);
- Amyl nitrate as an adjunct to current military cyanide treatment
regimen.
Michael Fonstein, Ph.D., Chief Executive Officer and President of Cleveland
BioLabs, stated, "We view this Sources Sought Notice as further
demonstration of the DoD's commitment to procuring the best possible
available medical countermeasures against a broad spectrum of CRN threats.
We believe CBLI has a very successful working relationship with the
CBMS-MITS JPMO, as they are currently providing assistance on discreet and
limited elements associated with the advanced development of our lead
radiation protection compound, Protectan CBLB502, in conjunction with other
federal agencies."
Cleveland BioLabs' Protectan CBLB502 has demonstrated statistically
significant increases in survival and mitigation of both gastrointestinal
and hematopoietic radiation-induced damage in rodent and non-human primate
models of ARS. The protective effects of CBLB502 were observed in primates
when administered as late as 72 hours after irradiation.
Protectan CBLB502 is being developed under the FDA's animal efficacy rule
to treat radiation injury following exposure to radiation from nuclear or
radiological weapons, or from nuclear accident. This approval pathway
requires demonstration of efficacy in representative animal models and
safety and drug metabolism testing in a representative sample of healthy
human volunteers. Cleveland BioLabs is currently concluding the first of
two human safety studies in healthy volunteers.
Cleveland BioLabs received, under a Broad Agency Announcement, a contract
valued at up to $8.9 million from the CBMS-MITS JPMO of the DoD in April
2008 providing assistance on discreet and limited elements associated with
the advanced development of the Company's lead radiation protection
compound, Protectan CBLB502. Cleveland BioLabs also received a contract
valued at up to $13.3 million from the Biomedical Advanced Research and
Development Authority of the of the Department of Health and Human Services
in September 2008 for certain elements related to the advanced development
of Protectan CBLB502.
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.
Contact Information: Contact:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com