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.
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 no alternatives other than the removal and reinsertion of the CVC once the CVC 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.
- Partnership with a leading cancer center and support from key industry opinion leaders.
- In a Phase 2b trial, the Mino-Lok™ product demonstrated a 100% efficacy rate in salvaging infected 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 QIDP designation and patent protected until June 2024.
- Advancing to a Phase 3 pivotal superiority trial.
Our Mino-Lok™ product was developed by clinicians and technologists at the M.D. Anderson Cancer Center. Citius 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 recently concluded negotiations to add South America to its worldwide license for Mino-Lok™. South America was the only territory that was not included in the original sub-license.
Professional market feedback suggests that there is an important need to develop an alternative to the standard of care for catheter-related blood stream infections (CRBSIs). Of the approximately 7 million central venous catheters (CVCs) used annually, about 500,000 or 7% become infected leading to serious, life threatening infections. Learn more about CRBSIs >>
The standard of care in the management of CRBSIs consists of removing the infected CVC and replacing it with a new catheter at a different vascular access site. These procedures are costly and 15% to 20% of the procedures are associated with significant morbidity. There are currently no approved therapies to salvage infected CVCs.
Certain patient populations are at particularly high risk for complications resulting from CRBSIs, including:
- Cancer and hemodialysis patients with long-term surgically implantable silicone catheters. Removal of the CVC and reinsertion of a new one at a different site may be difficult, or even impossible, because of the unavailability of other accessible vascular sites and the need to maintain infusion therapy.
- Critically ill patients with short-term catheters that have underlying coagulopathy, where the blood’s ability to clot is impaired. This condition makes reinsertion of a new CVC at a different site risky in terms of mechanical complications, such as hemopneumothorax, misplacement, or arterial puncture.
Citius completed a Phase 2b study in December 2014. There were 90 patients in the study, with 30 patients in the active arm and 60 patients in a matched cohort for comparison. All patients were receiving treatment at M.D. Anderson Cancer Center for hematologic or solid tumor cancers.
Outstanding Comparative Results
Our Mino-Lok™ product salvaged 100% of CVCs, helping to cure all of the bacteremias with no serious adverse events, compared to an 18% serious adverse event rate in the matched cohort where patients had the infected CVCs removed and replaced with a new CVC.
|Mino-Lok™ Arm||Control Arm|
|Patients||N = 30||Percent||N = 60||Percent|
|Bacteremia: Gram –||14*||47%||28||47%|
|Serious Adverse Events||0||0%||6||10%|
|Overall Complication Rate||0||0%||11**||18%|
* One polymicrobial patient had a Gram+ and a Gram– organism cultured
** Six patients had more than one complication
The Qualified Infectious Disease Product (QIDP) designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections.
Receiving QIDP designation means that our Mino-Lok™ product is eligible for additional FDA incentives in the approval and marketing pathway, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.
In October 2015, the FDA notified us that our Mino-Lok™ product had received a QIDP designation.
- Fast Track Status: Sponsors are granted early and frequent communications with the FDA.
- Priority Review: Reduces the NDA review time from 12 months to 8 months.
- Market Exclusivity: NDAs for QIDPs are granted an additional five years of market exclusivity with Hatch-Waxman for a combined total of ten years regardless of patent protection.
Phase 3 Study
Based on Phase 2b results, Citius believes that our Mino-Lok™ product is highly effective in salvaging infected indwelling catheters and is well tolerated, making Mino-Lok™ therapy an attractive alternative to removing and re-inserting a new CVC.
Citius plans to conduct a Phase 3, multi-center, randomized, double blind, placebo- and active- controlled study in 700 patients. Citius believes that the Mino-Lok™ product’s NDA can be approved within two and one half years based on the current development plan.