Protectan CBLB502 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
Science Magazine [1].
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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