Novel Antibody Lock Solution Improves Time to Failure Event in Common Cancer-Related Infection

The novel antibiotic lock solution Mino-Lok could help treat catheter-related infections that patients with cancer may experience.

The novel antibiotic lock solution, Mino-Lok^®, showed a statistically significant improvement in time to failure event compared with a control solution in patients with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI) that may occur from chemotherapy and other cancer treatments or procedures, according to results of the phase 3 MDA 2013-009 trial (NCT02901717), meeting the study’s primary end point.

Results showed that the time to catheter-failure events for patients on the Mino-Lok arm was substantially later than for those on the control arm, with a median time to failure that was not estimable (NE; 95% CI, 50-NE) and 33 days (95% CI, 14-44), respectively (HR, 0.53; P = .0006). In all patients who were randomly assigned to receive at least 1 dose of study lock solution, the overall treatment success rate was 57.1% with Mino-Lok vs 37.7% with the control regimen (P = .0025).

Data also showed that Mino-Lok was well tolerated, with no treatment-related serious adverse effects (AEs) reported. Serious AEs occurred in 45.1% and 46.1% of patients on the Mino-Lok and control regimens, respectively.

The developer of Mino-Lok, noted in a press release that it is looking forward to engaging with the FDA to determine the next course of action for the antibiotic lock solution.

"We are extremely pleased by the strong results of the trial, which demonstrate the safety and efficacy of Mino-Lok in preserving indwelling catheters in patients with bloodstream infections,” Leonard Mazur, chairman, and chief executive officer of Citius, stated in the release. “The data indicate, with a high degree of statistical significance, that Mino-Lok outperforms anti-infective lock solutions utilized in patients with CLABSI or CRBSI in the study's control arm. We believe Mino-Lok could potentially set a new standard of care as an adjunct therapy in the treatment of patients with bloodstream infections. This therapy offers a non-invasive treatment option compared to catheter removal and replacement.”

Mino-Lok combines minocycline and ethanol with edetate disodium for patients with CRBSIs and is designed to salvage catheters in patients with CLABSI or CRBSI. If approved, it would be the first and sole FDA-approved treatment to salvage central venous catheters that cause central line-related blood stream infections. Such infections can occur in patients with cancer who are undergoing chemotherapy, transfusions, parenteral nutrition, and blood sampling; CLABSI CRBSI can lead to prolonged hospitalization, increased resource utilization and treatment costs, delayed anticancer therapy, and increased mortality.

In the multicenter, open-label, active-controlled, double-blind trial, investigators evaluated the efficacy and safety of Mino-Link as an adjunctive treatment to systemic anti-infectives as a treatment for patients with CRBSI and CLABSI. Two hundred and forty-one patients in the United States and India were enrolled and randomly assigned 1:1 to receive Mino-Lok or standard-of-care site-specific anti-infective lock solution combined with standard systemic antibiotics. In the Mino-Lok arm, treatment was given at 1 dose daily with a 2- to 4-hour dwell time for a total of 7 doses up to 15 days; in the control arm, the antibiotic used in the lock, dose, dwell time, and number of days of administration was based on institutional standards of Infectious Diseases Society of America guidelines.

Patients had no limits on their catheter type.

The primary end point was time to a catheter failure event between randomization and the test of cure at 6 weeks, which was measured in the days following randomization. Catheter failure was defined as the inability to administer study lock solution, catheter removal for any infection-related reason, and all-cause mortality. Some of the secondary end points included overall success, microbiological eradication, and clinical cure.

Reference

Citius Pharmaceuticals achieves primary and secondary endpoints in phase 3 trial Of Mino-Lok antibiotic lock solution. Citius Pharmaceuticals. News release. May 21, 2024. Accessed June 11, 2024. https://shorturl.at/qo9mg