Policy & Regulation
Citius to advance Mino-Lok Phase 3 Trial under COVID-19 compliance
16 September 2020 -

Pharmaceutical company Citius Pharmaceuticals Inc (Nasdaq:CTXR) announced on Tuesday that it has filed an amendment to its Mino-Lok phase 3 protocol to allow for more efficient follow-up and record-keeping of required clinical trial documentation given COVID-19 restrictions.

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.

Following the restrictions of personal visits, the company has 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.

In these challenging times, the company is working closely with its Principle Investigators (PIs) to keep the enormous amount of record-keeping associated with any clinical trial as simple and accurate as possible. It plans to conduct its Drug Monitoring Committee meeting as planned at the end of the month and look forward to discussions with these independent experts, stated CEO Myron Holubiak.



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