SOURCE: Cleveland BioLabs, Inc.

October 18, 2007 10:59 ET

Cleveland BioLabs Completes Manufacturing Process for Protectan CBLB502

Pending Contract Decision From Department of Defense

BUFFALO, NY--(Marketwire - October 18, 2007) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) (BOST: CBLI) today announced that it has completed Good Manufacturing Practices compliant (cGMP) manufacturing of Protectan CBLB502.

Dr. Michael Fonstein, Chief Executive Officer and President of Cleveland BioLabs, stated, "We are pleased to report that the technology transfer to our manufacturing partner, SynCo Bio Partners, and production of the first cGMP batch of Protectan CBLB502 were both completed on schedule. The yields from the process and the purity of the final product exceeded our expectations. We were able to develop a complicated, high-yield manufacturing process for CBLB502 due to the excellent work of our sub-contractors at SynCo Bio Partners and our in-house team, which was able to prototype the process and resolve multiple challenges during industrial development together with our consultants."

"We currently have 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 in the coming months through our Phase I safety trial," continued Dr. Fonstein. "The process we developed gives us the ability to manufacture up to five million estimated doses within a year without any additional scale-up; and if necessary, scale-up could be implemented relatively easily. We are anticipating the contract decision from the Department of Defense this year."

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, as well as a commitment to purchase up to 500,000 doses, thereafter.

CBLB502 is undergoing an accelerated development program under the FDA two-animal rule, which requires demonstrations of efficacy in two animal species and only safety in humans. The Company plans to submit an Investigational New Drug (IND) application to the FDA for a human safety study this year.

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, 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

  • Contact:
    The Global Consulting Group
    Rachel Levine
    T: (646) 284-9439
    E: rlevine@hfgcg.com