Contact Information: Contact: Rachel Levine Director Corporate Development & Communications Cleveland BioLabs, Inc. T: (646) 284-9439 E: rlevine@cbiolabs.com
Cleveland BioLabs Opens Enrollment of Second Safety Study for CBLB502
| Source: Cleveland BioLabs, Inc.
BUFFALO, NY--(Marketwire - November 23, 2009) - Cleveland BioLabs, Inc. (NASDAQ : CBLI ) today
announced the opening of enrollment for 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 drug metabolism 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 25µg of CBLB502. The second dosing regimen
will be a single injection of 35µg of CBLB502. The third dosing regimen
will include administration of 400mg of Ibuprofen 30 minutes prior to a
35µg dose of CBLB502. The fourth dosing regimen will include two 30µg 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, once started. The primary objectives of
this study are to finalize a single dose to take forward into a pivotal
safety study in a larger group of healthy volunteers and gather additional
data on safety, PK, cytokine biomarkers in a larger and broader subject
population.
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.