ALUMINUM REMOVAL BY CHELATORS IMMOBILIZED IN HOLLOW FIBER

HEMEX, INC. HAS DEVELOPED A HOLLOW FIBER DEVICE WITH IMMOBILIZED CHELATORS FOR THE EXTRACORPOREAL REMOVAL OF TOXIC METALS FROM BLOOD, SPECIFICALLY ALUMINUM (A1). THIS DEVICE, SIMILAR TO A HEMODIALYSIS CARTRIDGE, IS A NOVEL APPROACH TO DETOXIFICATION, WITH UNIQUE ADVANTAGES OVER EXISTING TREATMENTS: (1) THE IMMOBILIZED CHELATOR DOES NOT ENTER THE BLOOD, MINIMIZING THE DANGER OF TOXICITY; (2) THE DEVICE FUNCTIONS WITH EFFICIENCY DUE TO THE LARGE CONCENTRATION OF CHELATOR AND EXTENSIVE CONTACT AREA AND IS SPECIFIC TOWARD A GIVEN METAL ACCORDING TO THE CHELATOR USED; AND (3) BLOOD COMPATIBILITY OF THE HOLLOW FIBERS ASSURES SAFETY OF APPLICATION. THE SAFETY AND EFFICACY OF THE PROPOSED DEVICE ARE PARTICULARLY ATTRACTIVE AS THE CURRENT CHELATOR THERAPY OF AL INTOXICATION HAS POTENTIAL TOXICITY. IN PHASE I, HEMEX, INC. PLANS TO FINALIZE DESIGN OF THE DEVICE BY SELECTING SPECIFIC CHELATORS FOR A1 AND TESTING THEIR EFFICACY IN VITRO, USING BLOOD FROM PATIENTS WITH A1 INTOXICATION. THE MOST EFFECTIVE DEVICE WILL BE FURTHER EVALUATED IN PHASE II IN EXPERIMENTAL ANIMALS TO ASSURE IN VIVO EFFICACY AND SAFETY. THE DEVELOPMENT OF THE OPTIMAL DEVICE WILL LEAD TO AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND CLINICAL TESTING IN PATIENTS ON CHRONIC HEMODIALYSIS.