SOURCE: Cleveland BioLabs, Inc.

December 13, 2007 15:23 ET

Cleveland BioLabs Recaps Development of Lead Compounds and Affirms Confidence in Competitive Position for Department of Defense Contract

Company to Host Year-End Update Conference Call December 17 at 10:00 a.m. EST

BUFFALO, NY--(Marketwire - December 13, 2007) - Cleveland BioLabs, Inc. (NASDAQ: CBLI), today announced that it will host a conference call to update investors on the progress of its clinical programs, research and development efforts, corporate developments, and the status of the Company's pending contract with the Department of Defense (DoD).

Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland BioLabs, stated, "As we approach the end of 2007, we are pleased with the advances we have made across all of our lead programs. We have achieved several major milestones on time and in line with our expectations. Our lead anticancer compound, Curaxin CBLC102, reached all of the technical benchmarks defined by the FDA in its first Phase II study. We have already launched a second Phase II and will be starting a third early next year. We continue our research and development efforts, which will bring our innovative tissue protecting drugs, Protectans, into clinical trials for medical use in 2008. Our stem cell program received a boost when we demonstrated that our leading molecule drastically outperformed a multi-billion dollar drug from a major biotechnology player, in a mouse model. On the corporate front, we have established a strategic research partnership with Roswell Park Cancer Institute (RPCI), a world-renowned cancer research hospital and the nation's first cancer research, treatment and education center. Our new dedicated facility on RPCI's medical campus will become the foundation for our advanced research and clinical trials.

"In addition, we remain confident that we are in a very strong competitive position to receive a significant contract from the DoD for our lead Protectan, CBLB502. Our estimation of receiving a decision and potential award from the DoD by the end of 2007 was based on the rapid pace of our multiple interactions and negotiations, which were concluded at the end of September, and left us with a highly positive impression. We expect the contract at any time in the near future. In the mean time, we are moving ahead with Protectan CBLB502's development for defense and medical uses and plan to initiate Phase I human safety trials, the only stage of human testing required by the FDA for approval in radiation protection for defense use, in early 2008."

The Company has announced several updates on its lead compounds over the past quarter:

On October 18, Cleveland BioLabs announced the completion of Good Manufacturing Practices compliant (cGMP) manufacturing of Protectan CBLB502. Dr. Fonstein noted that the Company currently has drug substance corresponding to over 100,000 projected human doses, or potentially many more, depending on the final therapeutic dose to be used, which will be determined through the Phase I safety trial.

Cleveland BioLabs submitted CBLB502 to the Department of Defense (DoD) in response to a Request for Proposal (RFP) for medical radiation countermeasures to treat gastrointestinal effects of acute radiation syndrome. The RFP award would provide funding for development of the countermeasure through FDA approval, leading to purchase of up to 500,000 doses, thereafter.

On November 26, CBLI announced the initiation of a Phase II efficacy study for Curaxin CBLC102 in advanced renal cell carcinoma (a highly fatal form of kidney cancer). Curaxin CBLC102 is currently in an ongoing Phase II trial in hormone refractory prostate cancer and an additional Phase II study of Curaxin CBLC102 in multiple cancer types is planned for early 2008.

On December 4, the Company shared results of a primate study demonstrating the efficacy of Protectan CBLB502 as a mitigator of hematopoietic (bone marrow/blood production) damage up to 48 hours post radiation exposure.

Dr. Fonstein said that this was the first primate study pointing towards CBLB502's high utility in protection of civil populations, where countermeasures would be stockpiled and then distributed, implying substantial delays and requiring efficacy many hours after the event of radiation. The Company believes that it has a very strong position in the anticipated competition for radiation countermeasures for the protection of the general population initiated by HHS.

In a Request for Information (RFI) published earlier this year, the Department of Health and Human Services (HHS) noted the agency's intention to pursue initial acquisition of 100,000 treatment courses of a medical countermeasure for neutropenia arising as a consequence of ARS. The RFI further stated that there would be options for up to an additional 100,000 treatment courses to meet the US Government's requirement of at least 200,000 treatment courses.

On December 12, CBLI announced results of a study of the effects of Protectan CBLB612, on propagation and mobilization to peripheral blood of hematopoietic stem cells (HSC) in comparison with G-CSF, the current market leading product, in mice.

Direct comparisons of CBLB612 and G-CSF, injected as single agents or in combination with AMD3100, a promising clinical-stage stem cell mobilizer, demonstrated much stronger efficacy of CBLB612 as a stimulator and mobilizer of HSC in peripheral blood. These results indicate a potential breakthrough for minimally invasive and more effective blood stem cell collection.

The Company will host a conference call to update investors on all of these developments on Monday, December 17, at 10:00 a.m. Eastern Standard Time. Interested parties may participate by dialing 877-407-8033 (US) or 201-689-8033 (International) approximately five to ten minutes before the call start time. A live Webcast of the conference call will be available on the Cleveland BioLabs Web site at www.cbiolabs.com.

A replay of the call will be available starting on December 17, 2007, at 1:00 p.m. Eastern Standard Time through December 24, 2007 at 11:59 p.m. Eastern Standard Time. Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering account number 286 and conference ID number 266260. An archived Webcast of the conference call will be available on the Cleveland BioLabs Web site at www.cbiolabs.com.

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, Roswell Park Cancer Institute, 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 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 periodic filings with the Securities and Exchange Commission.

Contact Information

  • Contacts:
    Rachel Levine
    Director Corporate Development & Communications
    Cleveland BioLabs, Inc.
    T: (646) 284-9439
    E: rlevine@cbiolabs.com