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news.Cleveland BioLabs, a drug discovery and development company, has completed dosing of the fourth cohort of healthy volunteers in the initial human safety study for Protectan CBLB502, a drug under development for the treatment for acute radiation syndrome.
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This initial safety study involves single injections of Protectan CBLB502 in ascending dose groups of six healthy volunteers each. Participants in the study are assessed for adverse side effects over a two-week time period and blood samples are obtained to assess the effects of Protectan CBLB502 on various biomarkers.
The study is currently projected to be completed in the spring of 2009 and would be followed by a second, larger safety study in healthy human volunteers, prior to submission of a biologic license application to the FDA.
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 preclinical activity of this product in animal models of acute radiation syndrome (ARS).