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WIKI ANALYSIS
CorMedix Inc. (AMEX:CRMD) is a pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic problems which share the common trait of underlying oxidative stress and blood vessel malfunction (endothelial dysfunction).
Below is a summary of the Company’s lead compounds in late-stage clinical development.
Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin)
Pending Pivotal Phase 3 Clinical Trial to Support PMA (Medical Device) FDA Submission
Expects to begin pivotal study 4Q10 with interim data projected during 2H11, anti-coagulant (heparin), anti-infective (taurolidine) agents in a liquid formulation for central vein catheters for initial use between dialysis sessions to keep free of infectious microbes and prevent blood clotting
Possible CE Mark clearance (Europe) by year-end 2010 for both dialysis (HD) and non-HD uses such as catheters used for nutrition (TPN), intensive care (ICU), and chemotherapy drug delivery,
Deferiprone (CRMD001) (a novel oral, twice-daily formulation of iron-binding or chelating drug)
Pending Phase 2 Pilot Clinical Trial
Expects to begin Phase 2 pilot study 2Q10 with expected data 4Q10, followed by pivotal Phase 3 study under SPA 4Q10 for contrast induced nephropathy (CIN) (kidney damage associated with medical imaging procedures), also has IND clearance from FDA to conduct Phase 2 study for chronic kidney disease (CKD)
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