Mino-Lok – Citius Pharmaceuticals

Mino-Lok® Overview

Antibiotic Lock Therapy for CRBSIs

Our Mino-Lok product is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs). CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.

Program Highlights

Address medical conditions that have unmet medical needs with cost-effective products.

  • Partnership with a leading cancer center and support from medical thought leaders.
  • In a Phase 2b trial, the Mino-Lok product demonstrated a 100% efficacy rate in salvaging colonized CVCs; the Mino-Lok product had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.
  • FDA Fast Track with QIDP designation and patent protection until June 2024. Formulation patent protection until November 2036.
  • Currently in a Phase 3 pivotal superiority trial.

Our Mino-Lok product is intended to salvage the CVC, obviating the need to remove and replace the catheter. This is a recognized unmet medical need. There are few alternatives to removing and replacing the CVC once it becomes infected. Studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.

Our Mino-Lok product contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. The Mino-Lok product is used in two-hour locking cycles, allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.

Infected double lumen catheter showing biofilm in both lumens.

Before
Biofilm accumulation
[Bacterial growth environment]

double lumen infected catheter

After use of Mino-Lok

after treatment with Mino-Lok

Our Mino-Lok product was developed by clinicians and technologists at the M.D. Anderson Cancer Center. Citius Pharmaceuticals obtained a worldwide license to the patented technology (with the exception of South America) in May 2014. In March 2016, Citius announced that it has a worldwide license for Mino-Lok.