Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs to Present Protectan CBLB502 at 2008 BARDA Day
Recently Awarded $13.3 Million BARDA Development Contract for Protectan CBLB502
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - September 23, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI )
announced today that it will present Protectan CBLB502 at the 2008
Biomedical Advanced Research and Development Authority (BARDA) Stakeholders
Workshop and Industry Day, September 24-26, in Washington, DC.
Cleveland BioLabs Chief Scientific Officer, Andrei Gudkov, Ph.D., D. Sci.,
has been invited to speak on Wednesday, September 24, at the Radiological
and Nuclear Therapeutics Session. His presentation, titled "Protectan
CBLB502 Prevents and Mitigates Hematopoietic and Gastrointestinal Acute
Radiation Syndromes by Mobilizing Multiple Natural Defense Mechanisms,"
will highlight Protectan CBLB502's demonstrations of efficacy and multiple
mechanisms of action, some of which were featured in a peer review
publication in the April 11 issue of Science.
In addition, Vadim Krivokrysenko, Ph.D., Protectan CBLB502 Project Leader
at Cleveland BioLabs, will exhibit a poster summarizing recent non-human
primate studies with Protectan CBLB502 titled, "Single Injection of Novel
Radioprotector CBLB502 Rescues Lethally Irradiated Non-Human Primates."
The goal of the HHS Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE) Stakeholders Workshop 2008 and BARDA Industry Day is to
provide an open forum for Government officials, pharmaceutical and
biotechnology industry representatives, state and local first responders,
public health advocates, academicians, and other key stakeholders to share
ideas for advancing public health preparedness in a collaborative
environment
Cleveland BioLabs was recently awarded a development contract from BARDA
for selected tasks in the advanced development of Protectan CBLB502. The
total contract value including all milestone-based options is $13.3 million
over a three-year period, with the first year's award of $3.4 million,
commencing September 16, 2008. Earlier this year, the Company was awarded
an $8.9 million development contract for Protectan CBLB502 from the
Department of Defense. The combination of these two awards is expected to
support the final stages of Protectan CBLB502's development necessary for
submission for FDA approval.
Cleveland BioLabs has successfully established cGMP quality manufacturing
for Protectan CBLB502, demonstrated preclinical efficacy and safety of this
product and recently received an allowance from the FDA to begin Phase I
clinical trials in human volunteers. Protectan CBLB502 is being developed
under the FDA's animal efficacy rule to treat radiation injury following
exposure to radiation from nuclear or radiological weapons, or from nuclear
accident. This approval pathway requires demonstration of efficacy in two
animal species and safety and drug metabolism testing in a representative
sample of healthy human volunteers.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is a drug discovery and development company
leveraging its proprietary discoveries around programmed cell death to
develop treatments for cancer and protection of 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 Radiobiology Research
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. The
Company's 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 the Company's periodic filings with the
Securities and Exchange Commission.