Citius Reports On Activities During Infectious Disease Week 2018
- Scientific Advisory Board meeting
- Investigators' meeting
- Sponsored satellite symposia on "Advances in the Prevention and Management of Central Line Associated Bloodstream Infection (CLABSI)"
CRANFORD, N.J., Oct. 23, 2018 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, reported on its recent activities in San Francisco. The meetings occurred at the same time as IDWeek 2018, but were not an official part of the IDWeek program.
The Citius Scientific Advisory Board (SAB) meeting was held on October 4 to discuss the progress of the Mino-Lok® pivotal phase 3 trial and the design of the second trial (if needed). The Chairman of the Citius' SAB is Dr. Issam Raad, Chair of MD Anderson Cancer Center's Department of Infectious Diseases, other members attending were Dr. Mark Rupp, Professor and Chief of the Division of Infectious Diseases at the University of Nebraska Medical Center, and Dr. Leonard Mermel, Professor of Medicine at Warren Alpert Medical School of Brown University.
A meeting of many of the principal investigators of the Mino-Lok® pivotal phase 3 trial was also held on October 4, 2018. The meeting was attended by 42 individuals representing 6 of the active sites in the Mino-Lok Phase 3 trial, and a number of other sites considering participation. A review of the progress of the trial and the sharing of techniques to expedite patient recruitment and enrollment was undertaken. Both investigators and clinical trial coordinators attended.
The Company also provided financial support for the symposium "Advances in the Prevention and Management of CLABSI" conducted by the Worldwide Institute of Medical Education. Central Venous Catheters (CVCs) have become essential devices in the model management of critically ill patients. However, CVCs are the most common source of bloodstream infections in this patient population. The attributable mortality of central line associated bloodstream infection (CLABSI) is up to 35%. Over the last decade, novel preventive strategies including antimicrobial CVCs and antimicrobial lock solutions have been developed. The symposium reviewed the progress and stressed an attitude of "zero tolerance" of CLABSI, and the need for a collaborative effort to achieve further gains.
"This past week has helped us to progress our development of Mino-Lok. We are especially indebted to our academic advisors who represent the opinion leaders on the accepted guidelines of how to treat CLABSI," said Mr. Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We hope to be able to communicate more exciting news as we continue to treat patients with CLABSI."
Mino-Lok is currently being studied in a phase 3 trial in over 17 medical centers in the United States. There are currently no approved therapies to salvage infected CVCs.
Catheter Related Bloodstream Infections (CRBSI) 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 CRBSI 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.
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.
About MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected facilities for cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 45 comprehensive cancer centers designated by the National Cancer Institute (NCI) and is ranked No.1 for cancer care in U.S. News & World Report's most recent "Best Hospital's" survey. The center has ranked as one of the nation's top two hospitals since the survey began in 1990, and has ranked first for 11 of the past 14 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).
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 our Phase 3 trial for Mino-Lok, including completing patient enrollment and opening study sites; our need for substantial additional funds; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the estimated markets for our product candidates and the acceptance thereof by any market; 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.
Vice President, Corporate Development
SOURCE Citius Pharmaceuticals, Inc.
Released October 23, 2018