US-based drug maker Cleveland BioLabs has teamed up with biopharmaceutical manufacturer Synco Bio Partners to produce its leading radioprotection molecule for clinical trials and commercialisation
Under the terms of the agreement, SynCo will manufacture Cleveland BioLabs' first radioprotector, Protectan CBLB502, under cGMP standards for Phase I safety testing in humans and commercial release.
According to SynCo, its facility has the capacity to produce significant doses of CBLB502 for potential national stockpiling.
Protectan CBLB502 is in the late stages of development for the treatment of acute radiation syndrome, which results from exposure to high levels of radiation following a nuclear or radiological incident.
The new compound is a modified protein of a microbe that protects cells from apoptosis - a programmed cell death - that has shown efficacy in protection against lethal doses of radiation in rodents and non-human primates.
With over 30,000 nuclear weapons now deployed around the world, the risk of a nuclear war by accident or intent has increased substantially and the market opportunity for a drug that reduces the effects of acute radiation syndrome could therefore be significant.
Currently there are no pharmaceuticals approved for use in protecting bone marrow from acute radiation syndrome, which is the part of the body usually damaged after a nuclear explosion.
"CBLB502's outstanding success as a radioprotectant in mouse and monkey clinical models provides us with confidence that we will have sufficient data to submit an New Drug Application for biodefense applications to the Food and Drug Administration (FDA) within 24 months," said Michael Fonstein, Cleveland BioLabs's CEO.
Other applications for this technology include protection from cancer treatment side effects.
Cleveland BioLabs said its development strategy for CBLB502 complies with recently implemented FDA rules for investigational drugs that address situations, such as radiation injury, where it would be unethical to conduct efficacy studies in humans.
While Phase II and Phase III human clinical trials are normally required for the approval of an investigational drug; under the new FDA rule, Protectan CBLB502 would be considered for approval for radiation protection based on Phase I safety studies in humans and efficacy studies in relevant primates.
SynCo, who produces a number of products for clinical trials and the commercial market, said this agreement further strengthens its position as "one of the premier contract manufacturers in the world."