With about 7 million used in the U.S. alone annually, central venous catheters (CVCs) are integral to healthcare as lifesaving access ports for patients needing extended intravenous therapy. To that point, market intelligence firm Future Market Insights forecasts the global CVC market will grow at a steady 5.1% compound annual growth rate in the decade to 2026, with North America continuing to dominate the space.
As critical as CVCs are to therapy for an array of diseases and conditions, they do have one serious flaw: infections. Each year in the U.S., about 472,000 catheters become contaminated, leading to life-threatening infections known as catheter related bloodstream infections (CRBSIs) and central line-associated bloodstream infections (CLABSIs). While there are clear distinctions between the two, they are often used in the same breath because of their similarities as intravascular devices and the fact that they cumulatively result in thousands of deaths annually and billions of dollars in added expense to the U.S. healthcare system.
When a CVC becomes infected, today’s standard of care is to remove and replace the catheter. That may sound simple enough, but the fact is that it is a surgical procedure, meaning that it is accompanied by all the associated risks and costs. When considering that the patients requiring the procedure are typically very sick already and sometimes seriously immunocompromised, the risks become exacerbated.
As detailed in a recent presentation on the popular website Virtual Investor Conferences, Citius Pharmaceuticals (NASDAQ: CTXR) is at the head of innovation to address CRBSIs and CLABSIs with its Mino-Lok, the world’s first experimental therapy to sterilize and salvage CVCs in place. Citius is developing Mino-Lok, a combination of minocycline, edetate and ethyl alcohol, under a Fast Track designation from the U.S. Food and Drug Administration as a Qualified Infectious Disease Product (QIDP) providing it with expedited review and additional protection from competition if it makes it to market.
The lock solution was initially developed by the venerable experts at the M.D. Anderson Cancer Center, followed by Citius licensing the technology in 2014 and finalizing a worldwide license in 2016.
Data from a 90-patient successfully completed Phase 2b clinical showed a 100% efficacy rate in eradicating infection from the CVC while it remained in the patient. Furthermore, there were zero complications or serious adverse events in the Mino-Lok group, versus an 18% complication rate in the control group where the CVC was removed and replaced.
Citius has advanced Mino-Lok into a 700-patient Phase 3 trial. According to Citius President and CEO Myron Holubiak, who previously was President of Roche Laboratories, the enrollment process is going well at this point, with 20 of 50 planned investigational sites initiated and 15 more in “start up” mode as documentation is finalized.
Citius will be looking for the Mino-Lok group to outperform the control group with regards to the primary endpoint of the portion of intent to treat patients that achieve success (eradication of pathogen, stabilization in infections symptoms, catheter salvage and survival) at the end of 8 weeks of treatment.
Holubiak and Chairman Leonard Mazur have provided tangible proof of their belief in Mino-Lok (as well as Citius’ Phase 2 experimental hemorrhoid treatment CITI-002) as evidenced in a recent $10 million capital raise to fund the company and its pipeline. Of the $10 million, Holubiak and Mazur invested $1 million and $4 million, respectively. Founders and insiders have consistently supported the company, contributing over $23 million in capital since inception.
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