BUFFALO, NY -- (Marketwire) -- 01/12/10 -- Cleveland BioLabs, Inc. (
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 - Current Opportunities
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.
Contact:
Rachel Levine
Director Corporate Development & Communications
Cleveland BioLabs, Inc.
T: (646) 284-9439
E: rlevine@cbiolabs.com