CorMedix to Present Data from Landmark Post-Approval Surveillance Study at National Kidney Foundation(R) 2016 Spring Clinical Meetings
ACCESS Newswire
BEDMINSTER, NJ / ACCESSWIRE / April 21, 2016 / CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that a clinical abstract highlighting data from the Company's landmark post-approval surveillance study will be presented as a poster during the National Kidney Foundation® 2016 Spring Clinical Meetings, held April 27 - May 1, 2016, in Boston, Massachusetts. The abstract, titled, "A Novel Taurolidine Containing Catheter Lock Solution (CLS) Without Reported Antimicrobial Resistance, Reduces the Rates of Infection and Thrombosis in Hemodialysis Patients Enrolled in a Post-Approval Surveillance Study," has also been accepted for publication in the peer-reviewed American Journal of Kidney Diseases.
This study, led by Dr. Markus Hollenbeck of the KfH Kidney Center Knappschaftskrankenhaus Bottrop, evaluated the use of Neutrolin®, CorMedix's CE Marked anti-infective solution for the prevention of catheter-related blood infections (CRBSIs) and thrombosis, which are the major complications observed in patients undergoing hemodialysis with indwelling central venous catheters. Under the study 194 hemodialysis patients at 19 hemodialysis centers in Germany were enrolled in the ongoing Neutrolin Use Monitoring Program (NUMP), representing 14,945 dialysis sessions over a 21-month period, for a total of 34,872 hemodialysis catheter days. These data demonstrated that use of Neutrolin is associated with 96.0% reduction in the rate of CRBSI and 96.6% reduction in thrombosis compared to published historical benchmarks of 3.5 CRBSIs and 2-3 episodes of thrombosis per 1,000 catheter days.
Randy Milby, CorMedix CEO, said, "The post-marketing data we're generating in Europe offers further validation and encouraging insight to Neutrolin's performance in a real world clinical setting. We look forward to leveraging these positive results, particularly as we seek to expand the use of Neutrolin to the United States, where we are currently underway with our pivotal Phase 3 clinical "LOCK-IT 100" (Catheter Lock Solution Investigational Trial) in hemodialysis patients with central venous catheters. We intend to submit the results in a New Drug Application to the U.S. FDA, which has already awarded Neutrolin Qualified Infectious Disease Product designation and Fast Track status, adding significant potential future value for this product."
Dr. Hollenbeck stated, "Dialysis Outcomes and Practice Pattern Study data, which we used as the benchmark in this study, emphasized that 30-50% of hemodialysis patients develop infection over a 3- to 6-month period and that the incidence of hemodialysis catheter thrombosis is as high as 46%. The evidence in this post-approval surveillance study indicates that Neutrolin, a non-antibiotic anti-microbial with no known resistance, could be a valuable clinical tool in the fight against these costly events."
About CorMedix Inc.
CorMedix Inc. is an emerging commercial-stage biopharmaceutical company that initiated a Phase 3 clinical study of a novel anti-infective solution, Neutrolin in hemodialysis patients in the United States in December 2015. The Company seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of infectious and inflammatory diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. The FDA has granted Fast Track status to Neutrolin Catheter Lock Solution and also has designated Neutrolin as a Qualified Infectious Disease Product for oncology, hemodialysis, and critical care/intensive care patients, where catheter-related blood stream infections and clotting can be life-threatening. The initial and planned indications aim to address significant needs in catheter-based treatments in the U.S. and the rest of the world. For more information visit: www.cormedix.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of studies regarding Neutrolin® conducted by us and others; the cost, timing and results of the planned Phase 3 trials for Neutrolin® in the U.S.; obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix's product candidates, including marketing of Neutrolin in countries other than Europe; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; the risks associated with the launch of Neutrolin in new markets; CorMedix's ability to enter into, execute upon and maintain collaborations with third parties for its development and marketing programs; CorMedix's ability to maintain its listing on the NYSE MKT; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources; the outcome of clinical trials of CorMedix's product candidates and whether they demonstrate these candidates' safety and effectiveness; CorMedix’s ability to identify and enter into strategic transactions; CorMedix's dependence on its collaborations and its license relationships; achieving milestones under CorMedix's collaborations; CorMedix's dependence on preclinical and clinical investigators, preclinical and clinical research organizations, manufacturers, sales and marketing organizations, and consultants; and protecting the intellectual property developed by or licensed to CorMedix. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
