Cleveland BioLabs Doses First Volunteers In Second Safety Study For CBLB502

Main Category: Radiology / Nuclear Medicine
Article Date: 20 Jan 2010 - 8:00 PDT

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Cleveland BioLabs, Inc. (NASDAQ: CBLI) 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.

Source
Cleveland BioLabs, Inc.

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