Business
Citius's Mino-Lok trial sites resupplied with registration batch product
CRANFORD, N.J., Sept. 30, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"CRANFORD, N.J., Sept. 30, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that the Mino-Lok Clinical Trial Material (CTM) at each of the clinical sites has been replaced with registration batch product. This means that going forward subjects enrolled in the trial will be treated with Mino-Lok that was manufactured with same process that will be used commercially should FDA approval be obtained. \n\"We are extremely pleased to be able provide common packaging for the 2 Mino-Lok components and to resupply our clinical sites with registration product,\" said Myron Holubiak, Chief Executive Officer of Citius. Holubiak continues, \"It's also important to note that we are prepared to immediately move to validation / commercial manufacturing upon completing our phase 3 clinical trial and receiving FDA clearance.\"\nAbout Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit www.citiuspharma.com.\nAbout Mino-Lok®Mino-Lok® is an antibiotic lock solution being developed as an adjunctive therapy in patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients, for whom venous access presents a challenge. There are currently no approved therapies for salvaging infected CVCs.\nSafe HarborThis press release may contain \"forward-looking statements\" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as \"will,\" \"anticipate,\" \"estimate,\" \"expect,\" \"should,\" and \"may\" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to ...