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Will 2021 Be A Banner Year For Citius Pharma?

citiuspharma feb22 lt

Citius Pharmaceuticals Inc. (CTXR) touched a two-year high of $2.16 last week, and has a couple of anticipated milestones lined up for the year.

The company's lead product candidate is Mino-Lok, an antibiotic lock solution, designed to treat patients with catheter-related bloodstream infections (CRBSIs).

Catheter-related bloodstream infections are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients.

Currently, there are no approved antibiotic lock therapies for the treatment of CRBSIs. The current standard of care is treating with culture-directed systemic antibiotic therapy with the removal of the infected central venous catheter and replacement with a new central venous catheter at a different site. But removal and reinsertion of central venous catheters have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.

There are no products being developed for the treatment of catheter-related bloodstream infections. Mino-Lok is the first and only therapy under investigation that can be used to sterilize and salvage the infected central venous catheter avoiding the complications, discomfort and costs of removal and replacement.

An antibiotic lock therapy for the prevention of catheter-related bloodstream infections, developed by CorMedix Inc. (CRMD), by the name Defencath, is under FDA review, with a decision expected on February 28, 2021.

Mino-Lok is under a pivotal phase III trial, with an interim analysis and review by the Data Monitoring Committee (DMC) expected in the second quarter.

In a phase IIb trial with Mino-Lok, which was completed in December 2014, Mino-Lok 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.

When a central venous catheter is left in place for 3 or more than 3 days after initiation of antibiotic treatment for suspected bacteremia, it is called catheter salvage.

The other products in the pipeline are Halo-Lido and Mino-Wrap.

Halo-Lido is a proprietary topical formulation of halobetasol and lidocaine to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids. The company expects to file an Investigational New Drug Application for Halo-Lido next quarter seeking FDA clearance to initiate a Phase 2b trial by year-end.

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

The company plans to start pre-clinical pharmacology and toxicology studies for Mino-Wrap within the next few months along with chemistry, manufacturing and controls (CMC) development, with filing of Investigational New Drug Application planned for the end of 2021.

Citius Pharma also has plans to make its foray into the COVID-19 landscape with its mesenchymal stem cell therapy for acute respiratory distress syndrome associated with COVID-19. The company is expected to submit an IND to the FDA and initiate a phase I first-in-human clinical trial in COVID-19 ARDS by the end of the second quarter of 2022.

Cash position:

The company, which ended the year 2020 with cash of $4.29 million, raised $20 million in a private placement offering in January and another $76.5 million in a registered direct offering last week.

In a letter to shareholders, dated Feb.16, Myron Holubiak, President and CEO of Citius Pharmaceuticals had written "Our important achievements against the COVID headwinds last year give us great confidence that 2021 will be a banner year for advancing our three product platforms in the clinic."

CTXR has traded in a range of $0.41 to $2.16 in the last 1 year. The stock closed Friday's (Feb.19, 2021) trading at $2.06, up 32.05%.

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