Mino-Lok™ Phase 3 Clinical Trial Supplies Shipped to Sites
Mino-Lok recently received Fast Track designation by the FDA
CRANFORD, N.J., Dec. 6, 2017 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, has announced that clinical trial supplies of Mino-Lok (minocycline/edetate/ethanol) have been sent to the University of Chicago Medical Center, and the Henry Ford Health System in Detroit, the first 2 clinical trial sites for the Mino-Lok phase 3 pivotal trial. When fully recruited, it is planned that there will be 50 participating sites, all located in the U.S.
The Mino-Lok solution is supplied as: 1) one stoppered glass vial containing lyophilized minocycline powder; and 2) one stoppered glass vial containing a sterile solution of edetate disodium in 25% ethanol. The mixing of the two vials will be prepared via standard pharmacy practices by reconstituting of the lyophilized vial of minocycline using the vial of sterile EDTA/ethanol solution.
Mr. Myron Holubiak, Chief Executive Officer of Citius, commented, "We have reached a key milestone in advancing this innovative product to an NDA. Mino-Lok clinical trial supplies have been sent to two of the most prestigious institutions in the US in preparation for the initiation of our phase 3 pivotal trial. We have discussed the urgent need to find an alternative to CVC removal as an approach to treating Catheter Related Blood Stream Infections (CRBSIs). We are very excited to finally begin our pivotal trial. We believe that the worldwide market potential for Mino-Lok exceeds $1 billion."
There are currently no approved therapies to salvage infected central venous catheters. CRBSIs are responsible for mortality rates of up to 25% in some patients, and contribute to significant morbidities.
Mino-Lok™ is under investigation and not approved for commercial use.
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 the University of Chicago Medical Center
The University of Chicago Medical Center, is an academic medical center on the South Side of Chicago. Affiliated with and operated by the University of Chicago, it serves as the teaching hospital for students of the institution's Pritzker School of Medicine. The University has been on the forefront of medical care since 1927, when it first opened to patients. It is now comprised of various hospitals and medical centers across Chicago and northwest Indiana. The University of Chicago Medical Center is ranked among the best in the country by U.S. News & World Report. It has been included on the magazine's "Honor Roll" of the best hospitals in the United States, and has made this coveted list 10 times. The medical center, staffed by 9,000 employees, offers the full range of specialty and primary care services for adults and children. Combining compassionate patient care and groundbreaking medical and biological research, the University of Chicago Medicine and Biological Sciences Division are at the leading edge of facing the world's most pressing medical challenges.
About the Henry Ford Health System
Henry Ford Health System is committed to improving the health and well-being of a diverse Michigan community. Founded in 1915 by auto pioneer Henry Ford and now one of the nation's leading health care providers, Henry Ford Health System is a not-for-profit corporation governed by a 17-member Board of Trustees, with volunteer-led advisory and affiliate boards providing additional leadership. It is comprised of hospitals, medical centers and one of the nation's largest group practices, the Henry Ford Medical Group, which includes more than 1,200 physicians practicing in over 40 specialties. The System's flagship, Henry Ford Hospital in Detroit, is a Level 1 Trauma Center recognized for clinical excellence in cardiology, cardiovascular surgery, neurology and neurosurgery, orthopedics, sports medicine, multi-organ transplants and cancer treatment. The Henry Ford Health System provides care to 3.3 million patient visits annually. With more than 30,000 employees, Henry Ford Health System is the fifth-largest employer in metro Detroit, and among the most diverse. Henry Ford Health System was one of only four 2011 recipients of the Malcolm Baldridge National Quality Award and the only organization in Michigan to receive it.
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; 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; 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.
Vice President, Corporate Development
SOURCE Citius Pharmaceuticals, Inc.
Released December 6, 2017