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Cleveland Biolabs Inc. To Respond To Department Of Defense "Sources Sought Notice" For Therapeutic Products To Treat Gastrointestinal Effects Of Acute Radiation Syndrome


11/17/2006 12:19:30 PM

CLEVELAND, Nov. 17 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc. , today announced that it will respond to a Sources Sought Notice, issued by The Department of Defense (DoD), through the Chemical Biological Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) Joint Product Management Office.

Dr. Yakov Kogan, Executive Vice President of Cleveland BioLabs commented, "This DoD request has great significance, in that it clearly identifies the necessity for a product that protects the GI tract. We believe that our lead compound, Protectan CBLB502, offers unique advantages to the military, first responders and civilian populations, in the event of a radiological event. We continue to work closely with the Armed Forces Research Radiobiology Institute and other partners to progress the development and approval of this compound."

According to the Sources Sought Notice, the DoD is seeking Prime Contractor(s) for advanced development activities associated with therapeutic products to either prevent or reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation or restoration of the anatomic integrity and normal physiologic functioning of the GI tract. These therapeutic products are being developed in response to a requirement to treat Armed Forces service members for the effects of radiation injury and to allow commanders to sustain and continue operations in the event of nuclear or radiological attacks on U.S. Forces.

There are currently no approved therapeutic treatments to protect against Acute Radiation Syndrome (ARS) or to mitigate ARS in victims of a radiological attack. A recent article in Military Medical Technology by Dr. Terry Pellmar, Scientific Director of the Armed Forces Research Radiobiology Institute explains that ARS is a continuum of syndromes. According to the article, Radiation doses over 1 Gy affect the bone marrow (hematopoietic syndrome) resulting in reduced neutrophil and platelet counts within a few weeks. Neutropenia increases susceptibility to infection, and loss of platelets leads to bleeding. Since the integrity of the gut wall is also impaired at these same doses, translocation of gut bacteria, which can lead to sepsis, becomes a concern as well. Hematopoietic and GI consequences are more severe with increasing doses. With partial body exposures, GI effects are evident because the sparing of bone marrow limits the hematopoietic symptoms. With whole body irradiation at doses greater than 8-12 Gy, GI consequences become the primary cause of death. Loss of intestinal crypts is severe and accompanied by extensive breakdown of the mucosal barrier.

Cleveland BioLabs' lead compound, Protectan CBLB502, is currently being developed to treat ARS, which will be submitted to the DoD. Protectan CBLB502 provides protection from ARS, if administered within several hours of radiation exposure. In addition, CBLB502 is the first compound of its kind to provide protection from both gastrointestinal and hematopoietic radiation- induced damage.

Protectan CBLB502 is able to protect and mitigate the damaging effects of gamma irradiation, suggesting for the first time, that victims of radiation exposure can be effectively treated. In addition, Protectan CBLB502 is a very stable compound and is ideal for rapid deployment using self-injectable devices.

According to the Sources Sought notice, a Prime Contractor will be responsible for conducting the advanced development activities and selecting and managing subcontractors capable of conducting various activities associated with drug development in manners that are consistent with eventual approval by the U.S. Food and Drug Administration (FDA).

The initial development of Protectan CBLB502 was supported by grants from the DHHS, through the BioShield Act, and NASA.

The Department of Defense's Sources Sought Notice can be publicly accessed from the following URL: http://www.fbo.gov/spg/USA/SMDC/DASG60/W9113M07S0001/SynopsisR.html.

Dr. Terry Pellmar's full article published in Military Medical Technology can be referenced from the following URL: http://www.military-medical-technology.com/print_article.cfm?DocID=1430.

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 that reflect our current view with respect to various aspects of the events described above. Actual results could be significantly different. Factors that could affect results include those set forth in filings made by Cleveland BioLabs, Inc. with the Securities and Exchange Commission. These factors include, but are not limited to, those discussed in our Registration Statement on Form SB-2 under the caption "Risk Factors."

Cleveland BioLabs, Inc.

CONTACT: Rachel Levine of The Global Consulting Group for ClevelandBioLabs, Inc., +1-646-284-9439, rlevine@hfgcg.com



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