CORMEDIX ANNOUNCES PUBLICATION OF TAUROLIDINE PRE-CLINICAL ONCOLOGY DATA IN “INVESTIGATIONAL NEW DRUGS” JOURNAL
July 8, 2019
Berkeley Heights, NJ – July 8, 2019 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced publication of in vitro and in vivo pre-clinical data demonstrating taurolidine’s effective anti-tumor properties in pediatric neuroblastoma. The paper, entitled: “Dual Functionality of the Antimicrobial Agent Taurolidine which Demonstrates Effective Anti-tumor Properties in Pediatric Neuroblastoma” appears in the July 2019 edition of Investigational New Drugs, a peer-review journal that provides a forum for the rapid dissemination of information on new anti-cancer agents.
“We are pleased to see data on taurolidine accepted for publication in this important journal,” said Paul Chew, M.D., Chief Medical Officer of CorMedix. “The data demonstrate a strong response to taurolidine against resistant human neuroblastoma cell lines in this pre-clinical animal model and suggests neuroblastoma and potentially other pediatric oncology indications as areas for further research.”
The study investigated the in vitro activity of taurolidine against neuroblastoma using the alamar blue cytotoxicity assay, phase-contrast light microscopy, western blotting, and analysis of global gene expression by RNA-Seq. In vivo activity of taurolidine was evaluated using mouse xenograft models. The study’s findings support the further investigation and evaluation of taurolidine in future pre-clinical studies and clinical trials for the treatment of pediatric neuroblastoma. Neuroblastoma is the most common extracranial solid tumor and one of the most complex and difficult-to-treat diseases in pediatric patients. The study was led by Dr. Aru Narendran, Professor of Pediatrics, Oncology, Biochemistry and Molecular Biology, Cumming School of Medicine, University of Calgary, with CorMedix providing financial support.
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in Phase 3 development for patients undergoing chronic hemodialysis. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. 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: relying on preclinical results that may not be indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; the risks and uncertainties associated with research for additional uses for taurolidine; risks relating to the effect of the recently-effected reverse stock split on the Company’s stock price and its overall market capitalization; the costs and time needed to submit a new drug application to the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; risks related to obtaining FDA approval of the new drug application for Neutrolin; and the ability to retain and hire necessary personnel to staff our operations appropriately. 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.