Contact Information: Contact: The Global Consulting Group Rachel Levine T: (646) 284-9439 E: rlevine@hfgcg.com
Cleveland BioLabs Completes Manufacturing Process for Protectan CBLB502
Pending Contract Decision From Department of Defense
| Source: Cleveland BioLabs, Inc.
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.