Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Doses First Volunteers in Second Safety Study for CBLB502
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - January 19, 2010) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced that the first healthy volunteers have been dosed in the second
human safety study for CBLB502, a drug under development for the treatment
of Acute Radiation Syndrome (ARS).
CBLB502 is being developed by Cleveland BioLabs under the U.S. Food and
Drug Administration's Animal Efficacy Rule to treat Acute Radiation
Syndrome (ARS) or radiation poisoning from any exposure to radiation such
as a nuclear or radiological weapon / dirty bomb, or from a nuclear
accident. This approval pathway requires demonstration of efficacy in
representative animal models and safety and pharmacodynamic drug marker
testing in healthy human volunteers.
Evidence of CBLB502's mechanism of action and activity in animal models was
published in Science Magazine in April 2008 (Science, 2008, vol. 320, pp.
226-230). Data from 50 subjects in an initial Phase I safety and
tolerability study indicated that CBLB502 was well tolerated and that
normalized biomarker results corresponded to previously demonstrated
activity in animal models of ARS.
This second safety study will include a total of 100 healthy volunteers
randomized among four dosing regimens of CBLB502. The first dosing regimen
will be a single injection of 25 micrograms of CBLB502. The second dosing
regimen will be a single injection of 35 micrograms of CBLB502. The third
dosing regimen will include administration of 400mg of Ibuprofen 30 minutes
prior to a 35 microgram dose of CBLB502. The fourth dosing regimen will
include two 30 microgram doses of CBLB502 administered 72 hours apart.
Participants in the study will be assessed for adverse side effects and
blood samples will be obtained to assess the effects of CBLB502 on various
biomarkers. Dosing of this study is currently projected to take
approximately six to eight weeks. The primary objectives of this study are
to gather additional data on safety, pharmacokinetics, and cytokine
biomarkers in a larger and broader subject population in order to finalize
an appropriate dose to take forward and determine the size of a definitive
human volunteer study.
The Biomedical Advanced Research and Development Authority (BARDA) of the
Department of Health and Human Services is supporting the entire cost ($1.3
million) of this clinical Phase 1b human safety study as part of contract
HHSO100200800059C.
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.