SANTA MONICA, CA / ACCESSWIRE / January 10, 2018 / Central venous catheters (CVCs) are a critical component of healthcare, with about seven million CVCs used every year to supply medicines, nutrients, fluids and blood products for a protracted time. In the U.S., about 250,000 catheter-related bloodstream infections (CRBSIs) occur every year (some estimates up to 500,000), exacerbating patient care, increasing billed costs as much as $129,000 and carrying a high mortality rate of 12-25 percent. Today's standard of care to treat an infected catheter is removal and reinsertion of a new one, which is problematic on many fronts, considering added expenses and the fact that 15-20 percent of these replacement procedures are associated with significant morbidity, such as a collapsed lung or arterial puncture.
Prevention is key, but in cases where infection occurs, leaving the CVC in place is the ideal solution. However, there are no FDA-approved therapies for salvaging an infected CVC, leaving it as a recognized area of unmet medical need and a substantial opportunity for Citius Pharmaceuticals (CTXR) and its Mino-Lok product. Citius has designed the antibiotic lock solution specifically for eradicating Gram-positive and Gram-negative bacteria while providing anti-clotting properties and salvaging the catheter in situ. The efficacy and safety of Mino-Lok have been proven in a Phase 2b clinical trial with a pivotal Phase 3 trial on tap.
Citius is developing Mino-Lok, a proprietary combination of minocycline, edetate (disodium EDTA) and ethyl alcohol, under a Qualified Infectious Disease Product (QIDP) designation by the Food and Drug Administration. Part of the Generating Antibiotic Incentives Now (GAIN) Act, QIDP is met to incentivize pharmas to develop new therapies for life-threatening conditions by expediting the review process and granting added years of market exclusivity, if approved.
In the 90-patient, mid-stage study hosted at M.D. Anderson Cancer Center, 30 patients were treated with Mino-Lok, with 60 patients in a control arm matched for comparison. Patients in the active arm had an array of infections, including one patient's culture showing both a Gram+ and Gram- organism. Regardless of the pathogen, complete microbiologic eradication was experienced in all 30 patients with zero relapses, complications or serious adverse events reported in the Mino-Lok cohort.
100% of the CVCs in the active arm were salvaged.
By comparison, in the control arm, where CVCs were removed and replaced, there was a 5% relapse rate and 10% of patients experienced a serious adverse event as part of an overall complication rate of 18%.
Citius is hoping to replicate its clinical success in the upcoming Phase 3 trial expected to enroll 700 patients across more than 50 U.S. sites. In December, shipments of the Mino-Lok constituents - which will be mixed on site - were sent to the University of Chicago Medical Center and the Henry Ford Health System in Detroit, signaling the trial is ready to begin.
''We are very excited to finally begin our pivotal trial. We believe that the worldwide market potential for Mino-Lok exceeds $1 billion,'' said Myron Holubiak, CEO at Citius, in announcing the milestone moment.
To move the trial forward, Citius raised approximately $6.0 million in December, selling institutions and accredited investors 1.28 million shares at $4.6925 per share, along with 640,180 warrants to purchase more shares at $4.63 per share ($2.96 million gross) over the subsequent 66 months. The raise, which happened at a premium to the current price, will fill corporate coffers that contained $3.2 million at the end of the third quarter.
It could be said that the race is on to complete development and commercialize a treatment for salvaging CVCs and reshaping the CRBSI paradigm, but it's pretty much a one-horse contest with Citius out in front. Based on the current development plan, and providing all goes well in the Phase 3 trial, Citius believes that a new drug application for the Mino-Lok product can be approved within two and one-half years.
With a 100% CVC salvage rate and a 100% efficacy rate in the Phase 2b study and a billion-dollar market opportunity, Wall Street and the pharmaceutical community will surely be paying attention.
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