CorMedix Inc (CRMD)

[KingDMC]

CorMedix Inc. Receives Positive Feedback from FDA for Neutrolin® Clinical Trial Protocol for Oncology Patients

Source: PR Newswire (US)
BEDMINSTER, N.J., June 17, 2015 /PRNewswire/ -- CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, today announced that the U.S. Food and Drug Administration (FDA) has provided positive feedback regarding a second pivotal clinical trial protocol. The new Phase 3 protocol is designed to assess the use of Neutrolin® as a catheter lock solution in oncology patients who require total parenteral nutrition (TPN) to support filing of a New Drug Application with the FDA. The comments provided by the FDA should enhance the quality of the proposed study.

Neutrolin has shown antimicrobial activity against many of the pathogens that result in catheter related bloodstream infections in the oncology community. Infections pose a significant risk for oncology patients, many of whom require the long-term use of central venous catheters. CorMedix hopes that the use of Neutrolin in this susceptible population will help address a critical unmet medical need. Previously, the FDA reviewed the pivotal Phase 3 clinical trial protocol to evaluate the use of Neutrolin in hemodialysis patients, and preparations are underway to initiate the trial subject to identification of funding or strategic partnering.

"CorMedix is thankful for the valuable feedback provided by the FDA, and we are encouraged by their continued enthusiasm and support of Neutrolin," said Randy Milby, CorMedix Chief Executive Officer. "We are optimistic that this trial will further our efforts to bring Neutrolin to market in the United States so that more patients can benefit from its use."

Neutrolin received QIDP and Fast Track designations earlier this year. These designations provide CorMedix with the opportunity to meet with the FDA on a more frequent basis during the review process, and provide eligibility for priority review of the marketing application.