CLEVELAND, Dec. 20 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc. , today announced that The Department of Defense (DoD), through the U.S. Army Space and Missile Defense Command (USASMDC), has provided notice that a Request for Proposal (RFP), for the Advanced Development of Medical Radiation Countermeasures (MRC) will be issued on or about January 10, 2007, with an anticipated contract award on or about July 20, 2007.
Dr. Yakov Kogan, Executive Vice President of Cleveland BioLabs commented, "We are excited to have the opportunity to respond to this RFP. We believe Protectan CBLB502's unique ability to protect against and mitigate the damaging effects of gamma irradiation on the gastrointestinal system, combined with its safety, stability and method of administration, make it a very strong candidate for this contract. Moreover, we are already in the process of completing current Good Manufacturing Practices (cGMP)-compliant manufacturing and plan to submit an Investigational New Drug (IND) application for human safety testing by the end of the summer 2007. If development continues on track, we expect to file a New Drug Application (NDA) for approval with the FDA within 20 months."
According to the Notice, The MRC shall be a drug or biologic that can be expeditiously developed, and when used after exposure to doses of ionizing radiation sufficient to cause the gastrointestinal (GI) syndrome of acute radiation syndrome, will either prevent/reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation/restoration of the anatomic integrity and normal physiologic functioning of the GI tract resulting in increased survival, reduced incapacitation, and sustained operational effectiveness. The MRC should be delivered by minimally invasive means and in as few doses as possible. The MRC should have minimal logistics requirements, preferably not requiring refrigeration.
Cleveland BioLabs' lead compound, Protectan CBLB502, is currently being developed to treat ARS and will be submitted to the DoD. CBLB502 is effective as a radioprotectant when administered as little as 15 minutes prior to exposure and as a mitigator, if administered up to one hour after exposure. CBLB502 is the first compound of its kind to provide protection from both gastrointestinal and hematopoietic (immune system) radiation-induced damage.
In addition, CBLB502 is stable in sterilized solution, not requiring refrigeration, and could be injected using self-injectable devices, which are the preferred delivery system in the field. Moreover, the compound does not display toxicity at therapeutic doses.
According to the notice, the Contractor will be responsible for conducting the various activities associated with drug/biologic development in manners that are consistent with eventual approval or licensure by the FDA. Proposed delivery schedule calling for delivery of the approved FDA product within 5 to 8 years after contract award is anticipated, but all proposed delivery schedules will be evaluated. The Company anticipates filing a New Drug Application to the FDA for approval within 20 months.
The Department of Defense's Presolicitation Notice may be publicly accessed from the following URL: http://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M-07-R-0002/SynopsisP.html.
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 Foundation, ChemBridge Corporation and the Armed Forces Research Radiobiology 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 often are proceeded by words such as "believes," "expects," "may," "anticipates," "plans," "intends," "assumes," "will" or similar expressions. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Our 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 our Registration Statement on Form SB-2/A filed with the Securities and Exchange Commission on September 8, 2006.
The Global Consulting Group
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Cleveland BioLabs, Inc.