Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Doses First Healthy Volunteer in Initial Safety Study for Protectan CBLB502
| Quelle: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - October 15, 2008) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that on October 14, the first healthy volunteer was dosed in the
initial human safety study for Protectan CBLB502, a drug under development
for the treatment for Acute Radiation Syndrome (ARS).
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 representative animal models and
safety and drug metabolism testing in a representative sample of healthy
human volunteers. Cleveland BioLabs has successfully established cGMP
quality manufacturing for Protectan CBLB502, and demonstrated pre-clinical
activity of this product in animal models of ARS.
This initial safety study will involve single injections of Protectan
CBLB502 in ascending dose groups of six healthy volunteers each.
Participants in the study will be assessed for adverse side effects over a
two-week time period and blood samples will be obtained to assess the
effects of Protectan CBLB502 on various biomarkers. The study is currently
projected to take approximately six months to complete and would be
followed by a second, larger safety study in healthy human volunteers,
prior to submission of a Biologic License Application (BLA) to the FDA.
Cleveland BioLabs received two development contracts totaling $22.2 million
from the Biomedical Advanced Research and Development Authority (BARDA) of
the of the Department of Health and Human Services (DHHS) and the
Department of Defense (DoD) for the advanced development of its lead tissue
protection compound, Protectan CBLB502, as a radiation countermeasure.
These two awards are expected to support the final stages of Protectan
CBLB502's development necessary for submission to the FDA for approval.
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.