October 17, 2008
Cleveland BioLabs Doses First Patient in Radiation Injury Treatment Study
Cleveland BioLabs, a drug discovery and development company, has dosed the first healthy volunteer in the initial human safety study for Protectan CBLB502, a drug under development for the treatment of acute radiation syndrome.
This initial safety study will involve single injections of Protectan CBLB502 in ascending dose groups of six healthy volunteers each. Participants in the study will be assessed for adverse side effects over a two-week time period and blood samples will be obtained to assess the effects of Protectan CBLB502 on various biomarkers.
The study is currently projected to take approximately six months to complete 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 received two development contracts totaling $22.2 million from the Biomedical Advanced Research and Development Authority of the of the Department of Health and Human Services and the Department of Defense for the advanced development of its lead tissue protection compound, Protectan CBLB502, as a radiation countermeasure. These two awards are expected to support the final stages of Protectan CBLB502's development necessary for submission to the FDA for approval.