CBLB502
Encyclopedia
Protectan CBLB502 is a drug being developed by Cleveland BioLabs, Inc, in Buffalo, New York. 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 cytokine
s.
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.
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.
Radiation therapy
Radiation therapy , radiation oncology, or radiotherapy , sometimes abbreviated to XRT or DXT, is the medical use of ionizing radiation, generally as part of cancer treatment to control malignant cells.Radiation therapy is commonly applied to the cancerous tumor because of its ability to control...
, 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
Apoptosis
Apoptosis is the process of programmed cell death that may occur in multicellular organisms. Biochemical events lead to characteristic cell changes and death. These changes include blebbing, cell shrinkage, nuclear fragmentation, chromatin condensation, and chromosomal DNA fragmentation...
. CBLB502 temporarily suppresses this response, enabling healthy cells to increase radiation resistance, and also reduces oxidative damage and induces regeneration-promoting cytokine
Cytokine
Cytokines are small cell-signaling protein molecules that are secreted by the glial cells of the nervous system and by numerous cells of the immune system and are a category of signaling molecules used extensively in intercellular communication...
s.
CBLB502 is in active development under the U.S. Food and Drug Administration's (FDA) Animal Efficacy Rule
Animal Efficacy Rule
The FDA Animal Efficacy Rule applies to development/testing of drugs / biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal /permanently disabling toxic agent , where human efficacy trials are not feasible or ethical.FDA can rely on evidence from animal...
to treat Acute Radiation Syndrome
Radiation poisoning
Acute radiation syndrome also known as radiation poisoning, radiation sickness or radiation toxicity, is a constellation of health effects which occur within several months of exposure to high amounts of ionizing radiation...
(ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon or dirty bomb
Dirty bomb
A dirty bomb is a speculative radiological weapon that combines radioactive material with conventional explosives. The purpose of the weapon is to contaminate the area around the explosion with radioactive material, hence the attribute "dirty"....
, 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.
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.