Citius's Mino-Lok trial sites resupplied with registration batch product

Rhea-AI Summary

Citius Pharmaceuticals (CTXR) announced on September 30, 2020, that the Mino-Lok Clinical Trial Material at clinical sites has been replaced with registration batch product. This transition allows trial participants to receive Mino-Lok manufactured with the same process intended for commercial use post-FDA approval. CEO Myron Holubiak expressed satisfaction in providing common packaging for Mino-Lok components and indicated readiness for commercial manufacturing following successful Phase 3 trials and FDA clearance.

Positive

• Transition to registration batch product for Mino-Lok enhances trial integrity.
• Preparedness for immediate commercial manufacturing post-FDA approval.

Negative

• None.

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. 

"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."

About 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.

About 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.

Safe Harbor
This 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 risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks associated with conducting clinical trials and drug development; our dependence on third-party suppliers;  our need for substantial additional funds; patent and intellectual property matters; market and other conditions; our ability to attract, integrate, and retain key personnel; the risk of successfully negotiating within the option period a license agreement with Novellus, Inc. for our planned NoveCite therapy for ARDS; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:
Andrew Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
(M) 646-522-8410
ascott@citiuspharma.com

View original content:http://www.prnewswire.com/news-releases/citiuss-mino-lok-trial-sites-resupplied-with-registration-batch-product-301141840.html

SOURCE Citius Pharmaceuticals, Inc.

FAQ

What recent development did Citius Pharmaceuticals announce regarding Mino-Lok?

Citius Pharmaceuticals announced the replacement of clinical trial material with registration batch product for Mino-Lok on September 30, 2020.

How does the replacement of clinical trial material affect the Mino-Lok trial?

The replacement ensures that trial participants receive Mino-Lok manufactured using the same process intended for future commercial use.

What did the CEO of Citius Pharmaceuticals say about commercial manufacturing?

CEO Myron Holubiak stated that they are ready to move to validation and commercial manufacturing after completing the Phase 3 trial and receiving FDA clearance.

What is Mino-Lok developed for?

Mino-Lok is an antibiotic lock solution aimed at treating central line-associated bloodstream infections (CLABSIs) and catheter-related bloodstream infections (CRBSIs).