C2E2-An Orally Administered Radionuclide Decorporation Agent

DESCRIPTION provided by applicant Capture Pharmaceuticals Inc is developing a drug called C E for treatment of individuals who have been contaminated by radioactive transuranic elements either by accident or following a nuclear terrorism event C E is a radionuclide decorporation agent that works by binding these elements in the bloodstream and enhancing their elimination before they can be trapped inside target organs such as the liver and skeleton Because it can be taken orally C E has significant advantages for use in a mass casualty scenario over currently available products which must be administered by intravenous injection and is superior to other competing technologies The ultimate goal of this project is to advance C E through FDA product registration and manufacture it for sale to local national and international parties that need to prepare for the potential of mass contamination of the population with radioactive elements like plutonium and americium This includes state and federal government agencies responsible for maintaining stockpiles of critical medicines e g the U S Strategic National Stockpile as well as foreign entities where the threat of nuclear terrorism is constant and imminent Capture had a pre IND meeting with the FDA at which time the regulatory pathway for C E was established A number of IND enabling tasks have been completed including detailed pre formulation characterization of the drug molecule extensive safety toxicology assessments and efficacy studies in animal models These studies demonstrated the feasibility of C E as an oral radionuclide decorporation agent and justify submission of this Direct to Phase II SBIR proposal The goal of this SBIR proposal which will be conducted by Capture and its academic partner UNC is to complete well defined IND enabling activities that will bring the C E product to a sufficient Technology Readiness Level so that subsequent funding from the Biomedical Advanced Research and Development Authority BARDA can be secured for manufacturing scale up activities safety assessment in humans efficacy measurements in animals as per the andapos Animal Ruleandapos and submission of a New Drug Application This will be achieved by completing metabolic and bioavailability studies with C E developing the Chemistry Manufacturing andamp Controls section of the IND completing safety pharmacology studies and preparing an IND application The continuing need for a radionuclide decorporation agent for accidental or deliberate contamination with transuranic elements has been highlighted by a INTERPOL report which warned of the increasing threat of nuclear terrorism and called for urgent preparedness In order to expand the commercial utility of C E its ability to serve as a Gd detoxifying agent following administration of MRI contrast agents will also be assessed The goals of this SBIR application fit the BARDA Strategic Plan for which emphasizes development of medical countermeasures not being developed by private industry to address unmet needs resulting from intentional threats to public health like nuclear terrorism as well as the goals of the Public Health Emergency Medical Countermeasures Enterprise PUBLIC HEALTH RELEVANCE The goal of this project is to complete specific studies with a new orally administered drug designed for use in individuals contaminated with certain radioactive isotopes so that it can ultimately be approved by the Food and Drug Administration included in the Strategic National Stockpile This new medical countermeasure addresses an unmet public health need which may result from intentional threats to public health such as nuclear terrorism