A Buffalo, N.Y. biotech company working on an experimental drug that could save victims from the deadly effects of radiation has offered to help with the ongoing nuclear crisis in Japan.

Cleveland BioLabs Inc. has spent the last few years developing CBLB502, also known as Protectan, a drug the company says is designed for moments like this, such as a power plant disaster.

The company says animal research suggests the drug can protect the body from some of the deadly effects of radiation poisoning, or acute radiation syndrome, including destruction of blood precursor cells in bone marrow and the lining of the gut. The drug is not yet cleared by the U.S. Food and Drug Administration and is still under investigation.

The agency has already "fast-tracked" the drug and granted it "orphan drug status," which grants tax credits and other benefits to companies researching cures to rare diseases, but it cannot yet be marketed to patients.

Rachel Levine, a spokeswoman for the company, told DOTmed News in an e-mail that they've "reached out" to U.S. authorities and can "offer a certain quantity of doses in final formulation, that could be 'ready to go' if needed and requested."

She wrote:

"CBLB502's intended defense use is for potentially lethal exposure to radiation, or at least rather high doses. We are not aware that that is the case in Japan and are not in a position to make that determination. We have done what we can at CBLI to reach out to appropriate US authorities that may be involved in any international cooperation or aid in this situation to make them aware of CBLB502's properties."

Levine said the company has "hundreds of thousands of doses available" in "bulk drug substance" but it would take time to render it into a final formulation. Also, since the drug is not approved by the FDA, federal authorities would have to OK it for emergency use. The company has no direct interaction with Japan.

"CBLI will continue to closely monitor the situation and make ourselves available to assist if needed. Our thoughts wishes are with the people of Japan for a rapid recovery from this disaster," Levine said.

Cleveland's stock surged to 52-week highs Tuesday, hitting $9.42 a share on Nasdaq, as investors were drawn to the promise of radiation-protecting medicine. But the stocks have started to slip back, falling 4 percent Thursday and closing at $7.60.

CBLB502 is derived from molecules that make up flagella, bacteria's tendril-like appendages. The company says the drug is also being tested for its effects in diminishing the side effects of a chemotherapy agent. Another drug from the same family of compounds, CBLB612, is also under investigation for aiding chemo recovery.

Levine explained the current state of the research:

"As for CBLB502's development for defense use, we are following the animal efficacy rule of the FDA, which is utilized in circumstances where it is unethical or infeasible to test efficacy of a drug in humans - i.e. we can't expose human subjects to potentially lethal or high doses of radiation to show efficacy. One tests efficacy in relevant animal species and does safety and tolerability testing in healthy human subjects, including biomarker analysis to demonstrate that activity in humans is consistent with animal efficacy results. We have characterized CBLB502's efficacy in many non-human primate and rodent experiments and done safety/tolerability and biomarker testing in 150 healthy human subjects through two studies, to date. Among steps left in our development are another set of animal studies under GLP conditions and according to FDA determined protocol, as well as a larger human safety study. Our goal is to complete all remaining development steps and to file a BLA with FDA over the coming 1-2 years."

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