Full Press Release Details
Reaches First Interim Analysis Milestone for
Mino-Lok Pivotal Trial
N.J. - October 7, 2019 -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty
pharmaceutical company focused on adjunctive cancer care and critical care drug products, today reported that the data cutoff
for the most recent patient treated and completing 8 weeks of observation has been reached. The Company is preparing the submission
to the independent Drug Monitoring Committee ("DMC") for review and evaluation.
objective of the Phase III pivotal trial for Mino-Lok is to evaluate the efficacy and safety of Mino-Lok in salvaging colonized
central venous catheters in subjects with catheter-related or central line-associated bloodstream infection (CRBSI/CLABSI) compared
to the standard of care using antibiotic locks.
primary endpoint for the trial is the time to a catheter failure event between randomization and the test of cure (TOC).
Mino-Lok protocol is based on reaching 92 catheter failure events for the trial, which corresponds to approximately 144 patients
treated in both arms combined.
are 2 interim analyses planned:
are extremely pleased to have reached this important milestone in the pivotal trial. With the great work performed at such institutions
such as MD Anderson Cancer Center, MedStar Georgetown University Hospital, Henry Ford Hospital, Cleveland Clinic, Carolinas Medical
Center, and Massachusetts General Hospital, among others, we have been able to progress to our first analysis of the data. There
is a huge medical need for a proven antibiotic lock. We are working hard to provide an alternative to submitting a very sick patient
to two surgical procedures to remove and possibly replace a tunneled or implanted venous port. We believe that this pivotal trial
will be the largest and best controlled clinical trial evaluating catheter salvage in diagnosed CLABSI patients to date. We are
doing everything possible to keep the momentum going," said Myron Holubiak, Chief Executive Officer of Citius Pharmaceuticals,
Citius Pharmaceuticals, Inc.
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.
is an antibiotic lock solution used to treat patients with CLABSIs/CRBSIs.
CLABSIs/CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs),
and in hemodialysis patients where venous access presents a challenge. There are currently no approved therapies to salvage
infected central venous catheters (CVCs).
is under investigation and not approved for commercial use.
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, opening study sites and achieving the required number of catheter
failure events; the estimated markets for our product candidates and the acceptance thereof by any market; our need for substantial
additional funds; risks associated with developing Mino-Wrap, including that preclinical results may not be predictive of clinical
results and our ability to file an IND; risks related to our growth strategy; our ability to identify, acquire, close and integrate
product candidates and companies successfully and on a timely basis; 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 attract, integrate,
and retain key personnel; 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.
President, Corporate Development