BUFFALO, NY -- (Marketwire) -- 05/28/09 -- 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.
