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Citius Publishes Expert Roundtable Discussion On Treatment Considerations For Catheter Related Bacteremias

SALVAGING INDWELLING CATHETERS IS ESSENTIAL WHEN THERE IS NO VASCULAR ACCESS AND THE PATIENT NEEDS LONG TERM CHRONIC PARENTERAL THERAPY

CRANFORD, N.J., Feb. 13, 2018 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, published the proceedings of a roundtable of experts today, entitled, "Treating CLABSI: A Clinical and Economic Challenge".

The experts participating in the roundtable included Infectious Disease specialists:

  • Ray Y. Hachem, MD, FIDSA, Professor of Medicine, Department of Infectious Diseases, Infection Control & Employee Health at U.T. M. D. Anderson Cancer Center;
  • Mayur S. Ramesh, MD, Senior Staff Physician, Infectious Diseases, Henry Ford Health System;
  • Mark E. Rupp, MD, Professor & Chief, Division of Infectious Diseases, University of Nebraska Medical Center; and,
  • Sharon Welbel, MD, Associate Professor, Rush Medical College; Director, Hospital Epidemiology and Infection Control, Cook County Health and Hospital Systems.

Joining them were Stuart Gordon, MSN, RN, Clinical Education and Practice Specialist Vascular Access at Legacy Health; and Salman S. Mufti, MD, Vascular and Interventional Radiologist.

The roundtable panel was organized to discuss the treatment of catheter related bacteremias and focusing on the issue of the nidus of the bacteremia: the infected central venous catheter (CVC). Additionally, the roundtable brought the disciplines of venous nursing care and interventional vascular management to the core specialty of Infectious Disease. 

The panel concluded that Central Line Associated Bloodstream Infections (CLABSIs) are some of the most difficult infections to treat, and are a leading cause of healthcare-associated infections (HAIs) with substantial morbidity and mortality. Many of these patients need to have their CVCs 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. Salvaging the existing catheter may be essential – or at the very least, far preferable to remove and replace – when faced with the following clinical conditions:

  • No vascular access
  • A very sick patient (e.g., ICU, hypotensive, thrombocytopenic) 
  • Need for long-term chronic parenteral therapy 
  • Acute leukemia or lymphoma 
  • Other comorbid conditions such as gross obesity.

"Citius has committed to providing much needed evidence that antibiotic lock therapy (ALT) is an attractive alternative to removing and replacing infected central lines," said Myron Holubiak, President and CEO of Citius. "Our phase 3 study comparing Mino-Lok to conventional ALT will be the largest and most definitive study of its kind conducted to date. We believe we will be able to show that Mino-Lok therapy, used in a very manageable dosing regimen namely two hours of lock time for 5 to 7 days, is superior to any other ALT locks that require substantially more dwell time and have not been thoroughly studied. We believe we will make a significant contribution to the body of knowledge on a variety of ALTs."

About the Mino-Lok Trial
The Mino-Lok trial is a Phase 3, Multi-Center, Randomized, Open-Label, Assessor-Blind Study to Evaluate the Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination with Systemic Antibiotics in the Treatment of Catheter-Related Bloodstream Infections.

About "Treating CLABSI: A Clinical and Economic Challenge"
Citius Pharmaceuticals, Inc., commissioned Aesculapius Consulting, Inc. to conduct an expert roundtable discussion on the treatment of Central Line Associated Blood Stream Infections. The proceedings of those discussions are available as the sponsored publication "Treating CLABSI: A Clinical and Economic Challenge" and can be requested by contacting Citius Pharmaceuticals, Inc.

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 that use 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. Citius develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches. For more information, please visit www.citiuspharma.com.

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 relating to the results of research and development activities, including our ongoing Phase 3 trial for Mino-Lok; risks associated with conducting clinical trials and drug development; the estimated markets for our product candidates and the acceptance thereof by any market; risks related to our growth strategy; 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; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; our need for substantial additional funds; government regulation; patent and intellectual property matters; 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) 908-967-6676
ascott@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.