Citius Pharmaceuticals Introduces Milo-Lok

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Specialty pharmaceutical company Citius Pharmaceuticals is dedicated to developing and commercializing therapeutic products for growing markets. Citius’ President and CEO Myron Holubiak spoke about the company’s four pipeline programs – Milo-Lok, Halo-Lido, Mino-Wrap and iMSC – at the Benzinga Global Small Cap Business Conference on May 13, 2021.

Halo-Lido is a proprietary topical formulation of halobetasol and lidocaine using 505(b)(2) to provide anti-inflammatory and anesthetic relief to people suffering from hemorrhoids.

Mino-Wrap, a malleable, bio-absorbable film impregnated with minocycline and rifampin, is designed to reduce infections associated with the use of breast-tissue expanders (TE) used in breast reconstruction surgeries following mastectomies.

Citius Pharmaceuticals (NASDAQ: $CTXR) partnered with Novellus Therapeutics Ltd. to form the subsidiary NoveCite to develop induced Mesenchymal stem cells (iMSCs), for the treatment of acute respiratory distress.

Mino-Lok, the lead product for Citius, is an antibiotic lock therapy for salvaging catheters that cause bloodstream infections in vulnerable populations. Administered in two vials, one containing minocycline and the other a combination of ethylenediaminetetraacetic acid (EDTA) and ethanal, Mino-Lok is intended to salvage central venous catheters.

“The problem with central venous, particularly in cancer patients and hemodialysis patients, is they become infected, and when they do it’s life-threatening,” Holubiak said during his presentation.

There are about 7 million central lines implanted every year in the United States, Holubiak said, and up to 500,000 can lead to serious bacteremia, which is the presence of bacteria in the bloodstream. These infections are associated with 12% to 25% mortality and morbidity. 

It costs a lot of money to deal with a CLABSI (central line-associated bloodstream infection) and the bundled payment system is somewhere in the $50,000 range, Holubiak said.

Of those funds, $10,000 is used for removing and replacing the catheter — two separate procedures. 

“That’s where our product comes in,” he said.

Mino-Lok is the first and only therapy under investigation that can be used to sterilize and salvage infected catheters, avoiding all the complications, discomfort and the cost of removal and replacement.

As Holubiak spoke about complications, he displayed figures that showed reported infections occur in 5% to 26% of patients, 5% to 19% of patients experience mechanical complications, and thrombotic, blood clot, complications occur at a rate of 2% to 26%. Holobiak also presented new information that he said people are not yet aware of.

Well over one-half to two-thirds of  patients report they have physical and psychological symptoms associated with catheter removal and reinsertion. That information was based on a study conducted by MD Anderson Cancer Center that Citius funded.

Holubiak said with Citius’s  program, the catheter is left in and sterilized instead of being removed and replaced. With a detailed diagram displayed, the catheter is filled with Citius’s solution and sits for two hours. The solution dwells in the locked catheter, so it doesn’t drip into the human body. At the end of the two hours it is aspirated and discarded. The line is then flushed with saline and the venous line is reinstituted.

The procedure is repeated over five to seven days, and to date salvaging the catheter has been 100% successful, Holubiak said. 

“This is our Phase 2b trial results,” he said. “We took them to the FDA. The FDA was impressed and authorized our Phase 3 study.”

Phase 3, called “Time to Catheter Failure,” looks at 21 versus 38 days in a 42-day period. Holubiak said Citius is well along with the trial and ready for its superiority efficacy analysis, which will happen this quarter. 

The company’s drug-monitoring meeting will take place in Q2, 2021 according to the timeline Holubiak provided.

Holubiak closed his presentation with the financial summary of the company, touted its attractive, diversified portfolio to potential investors while highlighting the nearly $104 million banked —enough to fund all the programs Holubiak showcased.

View the entire Citius Pharmaceuticals presentation here, and for more company information visit citiuspharma.com.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.