Citius Announces Expanded Access Program for Investigational Phase 3 Mino-Lok
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itius Pharmaceuticals, Inc. (Citius or the Company) (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced that it is providing free access to Mino-Lok for healthcare providers under an Expanded Access protocol to ease the burden associated with the COVID-19 pandemic.
Through the Expanded Access protocol, an infected central venous catheter can now be treated with Citius' Mino-Lok, potentially avoiding the need for the removal and replacement procedure. Given the challenges at today's hospitals, the patients, the hospital staff, and the hospital system at large stand to benefit greatly from free access to the Mino-Lok solution.
Some of our investigators have told us that if Mino-Lok were approved by the FDA, they would already be using it - particularly in today's environment, commented Myron Holubiak, Chief Executive Officer of Citius. We clearly must wait for the results of our clinical trial to fully market Mino-Lok, but we do believe that it can benefit patients and help ease the burden on the health care system. In these challenging times, we welcome the opportunity to help in any way we can.
Mino-Lok is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) in combination with an appropriate systemic antibiotic(s) to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion. Mino-Lok is currently in a Phase 3 clinical trial for the treatment of central line-associated bloodstream infections (CLABSIs). In early February 2020, the Company announced that the trial had reached the halfway point of enrollment.
Mino-Lok has the potential to change the standard of care, which currently calls for a procedure to remove and replace the infected catheter. Each year, up to 500,000 CVCs of the 7 million used become infected and lead to CLABSIs, increasing both patient morbidity risk and costs to the medical system. It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria, and there are currently no approved therapies for salvaging infected central venous catheters. According to DelveInsight, the market size of CLABSIs and closely associated catheter-related bloodstream infections (CRBSIs) in the global market is expected to reach $1.84 billion in 2028, up from $1.24 billion in 2017.
✔️ Citius Announces Expanded Access Program for Investigational Phase 3 Mino-Lok
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