Citius Files Addendum to Mino-Lok Phase 3 Trial Record Keeping Protocol to Advance Trials with COVID-19 Compliance

 

Source:  Citius Pharmaceuticals, Inc. 9/15/2020

-Mino-Lok trial continues to progress despite challenges of conducting clinical trials in COVID-stressed sites

-Interim efficacy review with Drug Monitoring Committee planned for end of this month

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has filed an amendment to its Mino-Lok phase 3 protocol. This amendment was designed to allow for more efficient follow-up and record-keeping of required clinical trial documentation given COVID-19 restrictions. With personal visits having been severely restricted, Citius issued instructions in the form of file notes to sites in April and has now formalized these instructions. The FDA released guidance on conduct of clinical trials of medical products during COVID-19 in March 2020, updated in July 2020.

"In these challenging times we are working closely with our Principle Investigators (PIs) and their staff to keep the enormous amount of record-keeping associated with any clinical trial as simple and accurate as possible," said Myron Holubiak, Chief Executive Officer of Citius. Holubiak continues, "We have been pleased with the responsiveness of our partners and internal team to today's ever-changing situation. Like all other companies, Citius is facing significant challenges in maintaining progress in its clinical trials. We are especially affected since our site-of-care is frequently the ICU, which is the most resource-stressed site in the hospital because of COVID-19. We expect to be able to conduct our Drug Monitoring Committee meeting as planned at the end of the month, and we look forward to our discussions with these independent experts."

About Citius Pharmaceuticals, Inc.
Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit www.citiuspharma.com.

About Mino-Lok®
Mino-Lok® is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients, for whom venous access presents a challenge. There are currently no approved therapies for salvaging infected CVCs.