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CorMedix's late stage Neutrolin study underway; shares rise 18%

Dec. 14, 2015 3:39 PM ETCorMedix Inc. (CRMD) StockCRMDBy: Douglas W. House, SA News Editor9 Comments
  • Thinly traded nano cap CorMedix (CRMD +18.2%) is up on triple normal volume in response to its announcement that the first patient has been dosed in its Phase 3 clinical trial, LOCK-IT-100, assessing Fast Track- and QIDP-tagged Neutrolin in preventing catheter-related bloodstream infections (CRBSIs) in patients with end stage renal disease receiving hemodialysis.
  • The primary endpoint of the 633-subject, randomized, double-blind, placebo-controlled, active control study is freedom from CRBSIs, specifically Neutrolin's superiority in preventing CRBSIs compared to active control (the blood thinner heparin) or normal control (saline).
  • In the U.S., there are 250K CRBSIs each year with mortality rates of 20 - 25%.
  • Neutrolin, a novel formulation of the antimicrobial agent taurolidine, citrate (salt) and heparin, keeps catheters operating safely and effectively by decreasing the risk of infection, thrombosis and biofilm formation. It is CE Mark cleared in Europe but not yet approved in the U.S.
  • Previously: CorMedix gaps up 14% on FDA guidance that beefs up late-stage Neutrolin trial (June 17)

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