Associated tags: CVC, Patient, FDA, MD Anderson Cancer Center, University, ITT, IDSA, Minocycline, MLT, Control, Safety, Pharmaceutical industry, Infectious Diseases Society of America, Clinical trial, Citius, Altius, Fortius
CRANFORD, N.J., Jan. 2, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has completed enrollment in its pivotal Phase 3 clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. A total of 109 catheter failure events were observed in the event-based trial; a minimum of 92 catheter failure events were required to complete the trial. The study enrolled 241 patients at clinical sites in the U.S. and India.
Key Points:
- A total of 109 catheter failure events were observed in the event-based trial; a minimum of 92 catheter failure events were required to complete the trial.
- The study enrolled 241 patients at clinical sites in the U.S. and India.
- "Completing enrollment in our pivotal Phase 3 trial is a crucial milestone in the development of Mino-Lok, bringing us closer to addressing the limitations of the current standard of care for patients with catheter related blood stream infections (CRBSI).
- We extend our deepest appreciation to the patients, investigators, and healthcare professionals who have been integral to the successful enrollment of this trial," stated Leonard Mazur, Chairman and Chief Executive Officer of Citius.
Retrieved on:
Thursday, August 10, 2023
Infectious Diseases Society of America,
MLT,
Clinical trial,
Minocycline,
IDSA,
Patient,
Control,
ITT,
Safety,
Pharmaceutical industry,
Citius, Altius, Fortius Pending confirmation from an adjudication committee of independent reviewers, the Company believes all 92 events required to complete the trial have been achieved.
Key Points:
- Pending confirmation from an adjudication committee of independent reviewers, the Company believes all 92 events required to complete the trial have been achieved.
- Several patients remain in active treatment, which may result in additional events.
- "This is a significant milestone for Citius as we approach completion of the Phase 3 Mino-Lok trial.
- The Mino-Lok Phase 3 pivotal superiority trial ( NCT02901717 ) is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium.
Infectious Diseases Society of America,
MLT,
Clinical trial,
Minocycline,
IDSA,
Patient,
Control,
ITT,
Safety,
Pharmaceutical industry,
Citius, Altius, Fortius Of the 92 events required to complete the trial, the Company estimates that 85 events have been achieved to date.
Key Points:
- Of the 92 events required to complete the trial, the Company estimates that 85 events have been achieved to date.
- The trial has enrolled 190 patients, of which 16 patients are in active treatment or pending study completion data review, which may result in additional events.
- The multi-center Mino-Lok® Phase 3 trial continues to recruit patients at 35 clinical trial sites in the U.S. and India.
- With an estimated 85 achieved events to date, we believe we are nearing the finish line," stated Leonard Mazur, Chairman and CEO of Citius.
