Source: Citius Pharmaceuticals, Inc. 6/19/18
Citius Pharmaceuticals, Inc. ("CITIUS") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company, announced that Mino-Lok® is now a registered trademark with the U.S. Patent and Trademark Office. Citius' Mino-Lok® product is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs). CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs), and in hemodialysis patients where venous access presents a challenge.
Citius' Mino-Lok® product is intended to salvage the CVC obviating the need to remove and replace the catheter. This is a recognized unmet medical need. There are no alternatives other than the removal and reinsertion of the CVC once the CVC becomes infected. Studies show that removal and reinsertion of CVCs have a 15 to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.
"We are working towards FDA approval and commercialization of Mino-Lok, We are currently conducting a Phase 3 clinical trial and are treating patients with Mino-Lok compared to standard antibiotic lock therapies," said Mr. Myron Holubiak, CEO of Citius. "Hopefully, we will be able to complete our trial next year and begin the NDA review process. Mino-Lok has been granted "Fast Track" status by the FDA for this development program."
The Company's Mino-Lok® product contains a proprietary combination of minocycline, edetate (disodium EDTA), and ethyl alcohol, all of which act synergistically to break down bacterial biofilms, eradicate the bacteria, provide anti-clotting properties to maintain patency in CVCs, and salvage the indwelling catheter. The Mino-Lok™ product is used in two-hour locking cycles allowing the CVC to be used for its intended purposes for the remaining 22 hours each day.
Mino-Lok® is under investigation and not approved for commercial use.
About Citius Pharmaceuticals, Inc. Citius is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infectives, cancer care and unique prescription products using innovative, patented or proprietary formulations of previously approved active pharmaceutical ingredients. We seek to achieve leading market positions by providing therapeutic products that address unmet medical needs. By using previously approved drugs with substantial safety and efficacy data, we seek to reduce the risks associated with pharmaceutical product development and regulatory requirements. We focus on developing products that have intellectual property protection and competitive advantages to existing therapeutic approaches. www.citiuspharma.com
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