SRI International Receives U.S. FDA Clearance for Investigational New Drug Application Evaluating Novel Oral Treatment to Combat Radiation Exposure | SRI International

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SRI International Receives U.S. FDA Clearance for Investigational New Drug Application Evaluating Novel Oral Treatment to Combat Radiation Exposure

MENLO PARK, Calif.—March 30, 2017— SRI International has received U.S. Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application to evaluate a novel, oral formulation of zinc diethylene triamine pentaacetate) (ZnDTPA) as a treatment for radiation exposure. ZnDTPA is an agent that removes heavy metals from the body (decorporation agent) by sequestering and increasing rates of elimination of these radionuclides, thus preventing serious, life-threatening health effects from mass radiation exposure.

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Zn-DTPA is currently available only as an intravenous (IV) medication, which is not ideal in mass exposure emergency situations such as a nuclear accident or terrorist attack.

The IND enables SRI to initiate a Phase 1 trial investigating safety, tolerability and pharmacokinetics of “PO” (per os – oral) formulation of Zn-DTPA in healthy human volunteers. Under the current development plan, SRI will be able to submit a New Drug Application (NDA) to the FDA following successful completion of the Phase 1 study.

Previous industry attempts to re-formulate Zn-DTPA from an IV into pill form were hampered by formulation challenges as well as the requirement for room temperature-stable product for stockpiling purposes. SRI’s Zn-DTPA tablet was developed using SRI’s proprietary “IV to PO” platform that includes screening techniques to identify combinations of potent absorption enhancers that can improve oral bioavailability.

“This IND validates our innovative IV-to-PO platform technology that leverages SRI’s advanced formulation tools and extensive staff experience in identifying alternative approaches to developing oral formulations of already-approved IV products,” said Gita Shankar, Ph.D., director, Formulations R&D, SRI Biosciences, and principal investigator for the Zn-DTPA project. “We look forward to rapidly completing this trial and then moving toward FDA approval of oral Zn-DTPA.”

SRI developed oral Zn-DTPA under a contract from the U.S. National Institutes of Health.