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Cleveland BioLabs opens enrollment in acute radiation syndrome study

Posted on: Thu, 26 Nov 2009 08:16:00 EST

Symbols: CBLI

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Nov 26, 2009 (Datamonitor via COMTEX) --
CBLI | Quote | Chart | News | PowerRating -- Cleveland BioLabs has opened enrollment for the second human safety study for CBLB502, a drug under development for the treatment of acute radiation syndrome or ARS.

CBLB502 is being developed by Cleveland BioLabs under the FDA's Animal Efficacy Rule to 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.

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 25g of CBLB502.

The second dosing regimen will be a single injection of 35g of CBLB502. The third dosing regimen will include administration of 400mg of ibuprofen 30 minutes prior to a 35g dose of CBLB502. The fourth dosing regimen will include two 30g 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, pharmacokinetic, cytokine biomarkers in a larger and broader subject population.

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