Citius Pharmaceuticals Inc. ("Citius") ("Company") (CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, received official notification from MD Anderson Cancer Center ("MDACC") that the European Patent Application (No. 16806326.1) for Mino-Lok with Enhanced Stability was published (September 12, 2018) under serial number 3370794. This patent which already received a Notice of Allowance from the US Patent and Trademark Office in July of 2018, and which patent was issued by the USPTO earlier this month, will provide and strengthen intellectual property protection for Mino-Lok through November of 2036.

The new invention overcomes limitations in mixing antimicrobial solutions, in which components have precipitated because of physical and/or chemical factors, thus limiting the stability of the post-mix solutions. The scientists and technologists at MDACC have been able to improve the stability of the post-mixed solutions through adjustments of the post-mixed pH of the solution. This may allow for longer storage time of the ready-to-use solution.

"The protection of company's intellectual property is vital, and enhanced post-reconstitution stability of the Mino-Lok is a very important innovation," said Mr. Myron Holubiak, President and CEO of Citius Pharmaceuticals. "This will enable standard pharmacy process to be employed in the delivery of Mino-Lok to the patient, and would allow for several days' storage of ready-to-use Mino-Lok. This new European patent will provide us broader protection in the major markets of the world for our new formulation."

Citius holds the exclusive worldwide license to this patented technology.

Mino-Lok is currently being studied in phase 3 in over a dozen medical centers in the United States. There are currently no approved therapies to salvage infected central venous catheters (CVCs). 

Catheter-related bloodstream infections (CRBSIs) are some of the most difficult infections to treat and are a leading cause of healthcare-associated infections (HAIs) with substantial morbidity and mortality. Patients with CRBSIs may be at risk for serious complications, including septic thrombosis, endocarditis, and disseminated infection. Many of these patients need to have their central venous catheters removed and subsequently replaced, causing added costs, morbidities and discomfort. Removal and reinsertion of a new CVC may be difficult or even impossible due to the unavailability of other accessible vascular sites. Furthermore, critically ill patients often have underlying coagulopathy, which may increase the risk of mechanical complications (e.g., hemopneumothorax, misplacement, or arterial puncture with severe hematomas and attendant blood loss) with the reinsertion of a new catheter at a different site.

Mino-Lok® is under investigation and not approved for commercial use.

 For more information, please visit www.citiuspharma.com.