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Entolimod

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CBLB502

Protectan CBLB502 <ref>[1] Magazine in April 2008 / <ref> is a drug being developed by Cleveland BioLabs, Inc, in Buffalo, NY. CBLB502 was originally created in an effort to protect healthy cells during radiotherapy, so that more aggressive measures could be taken to attack malignant cells and increase the effectiveness of cancer treatment. Radiation damages healthy cells in a way that causes them to activate the regulated cell death process, known as apoptosis. CBLB502 temporarily suppresses this response, enabling healthy cells to increase radiation resistance, and also reduces oxidative damage and induces regeneration-promoting cytokines.

CBLB502 is in active development under the U.S. Food and Drug Administration's (FDA) Animal Efficacy Rule to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon or 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.

CBLB502 is the first medical radiation countermeasure of its kind and demonstrates protection from radiation damage in animal models when injected both pre- and post-exposure to ionizing radiation. CBLB502 has been shown to significantly reduce mortality and decrease incapacitation in animal models if injected more than 24 hours after a radiological or nuclear event. Evidence of CBLB502's mechanism of action and activity in animal models was published in <ref>[2] Science Magazine in April 2008 / <ref>).

Data from 50 human 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. As part of the development of CBLB502, this study will be followed by a second, larger safety study in healthy human volunteers, which will be based on the results of the initial study. There is currently no FDA approved medical countermeasure to treat ARS.


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