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CorMedix Inc., a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced that it is in negotiations with its contract research organization (“CRO”) regarding certain remediation efforts and financial considerations for the ongoing delay incurred by the Company in performing the interim efficacy analysis of the LOCK-IT-100 study. The Company is currently anticipating that the Data Safety Monitoring Board (“DSMB”) will review the interim analysis and make its recommendations in July 2018, rather than in the second quarter, assuming no further significant delays in obtaining the additional data needed to assess secondary endpoints and severe adverse events (SAE’s) to complete the review process are encountered. The Company is assessing the impact of this delay and the possible outcomes of its CRO discussions on its anticipated cash needs, and expects to provide an update as soon as it has the information necessary to accurately assess such requirements.
Khoso Baluch, President and CEO of CorMedix commented, “Lapses in data collection on SAE’s and other requirements for the interim efficacy analysis we discovered have jeopardized our ability to meet the goals we set and communicated to our shareholders and business partners with respect to the timing of the completion of the interim efficacy analysis. We have therefore brought in-house and assumed direct responsibility for several aspects of the study, among them site management and review of SAE’s for the remainder of the study. Our CRO is working cooperatively with us on the other operational aspects of the study.”
Mr. Baluch continued, “The integrity of the 28 catheter-related bloodstream infections confirmed by the Clinical Adjudication Committee (“CAC”) is not an issue. In the meantime, we have continued to identify and prepare additional cases of suspected catheter-related blood stream infections for assessment by CAC as we proceed towards the study’s conclusion.”
The Catheter Lock Solution Investigational Trial, or LOCK-IT-100 Trial is a multi-center Phase 3 clinical trial in hemodialysis patients with central venous catheters in the U.S. It is a prospective, randomized, double-blind, active control trial designed to demonstrate the efficacy and safety of Neutrolin in preventing catheter-related bloodstream infections (CRBSI) in subjects receiving hemodialysis therapy as treatment for end stage renal disease. The trial will evaluate whether Neutrolin is superior to the active control heparin by documenting the incidence of CRBSI and the time until the occurrence of CRBSI as the primary endpoint. Key secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activator (tPA) or removal of catheter due to dysfunction and catheter removal for any reason. LOCK-IT-100 is an event-driven study and study completion is dependent upon capturing 56 total CRBSI events.
For Further Information
More on the vascular access device market in the U.S. can be found in a series of reports published by iData Research, entitled the U.S. Market Report Suite for Vascular Access Devices and Accessories 2018. The U.S. market for vascular access devices and accessories includes implantable ports, port needles, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), peripheral intravenous catheters (PIVCs), midlines, dialysis catheters, ultrasound systems, tip guidance devices, catheter securement devices, syringes and needles.
The iData report series on vascular access devices covers the U.S., Brazil, South Korea, Japan, Australia, China, India and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxembourg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about vascular access device market data, register online or email us at [email protected] for a U.S. Market Report Suite for Vascular Access Devices and Accessories 2018 brochure and synopsis.