CRANFORD, N.J., Oct. 3, 2019 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a
specialty pharmaceutical company focused on adjunctive cancer care
and critical care drug products, today reported Company activities
at ID Week, the annual meeting of the Infectious Diseases Society
of America (IDSA), the Society for Healthcare Epidemiology of
America (SHEA), the HIV Medicine Association (HIVMA), and the
Pediatric Infectious Diseases Society (PIDS).
The Citius Scientific Advisory Board (SAB)
Citius held
an in-person Scientific Advisory Board (SAB) meeting in conjunction
with IDWeek. In attendance were chairman of the SAB, Dr.
Issam Raad M.D., Chair of M.D.
Anderson Cancer Center's Department of Infectious Diseases and the
Endowed Distinguished Professor of Medicine; Dr. Mark Rupp M.D., Professor and Chief of the
Division of Infectious Diseases in the Department of Internal
Medicine at the University of Nebraska Medical
Center (UNMC); Dr. Leonard Mermel
D.O., Professor of Medicine at Warren Alpert Medical School
of Brown University Medical; and, Dr.
George M. Viola M.D., Associate
Professor of Infectious Diseases and the Clinical Medical Director
of the Solid Cancer and Surgical-Related Infections Service at the
University of Texas M.D. Anderson
Cancer Center.
The Company presented progress on the Mino-Lok Phase III trial,
along with the plans for the development of Mino-Wrap, the
bioabsorbable gelatin wrap in development to prevent tissue
expander infections post-mastectomy. Additionally, management
presented possible strategic scenarios for discussion and
advice.
"We appreciate the strategic insight provided by our SAB
members," said Mr. Myron Holubiak,
Chief Executive Officer of Citius. "They are leaders in the
field of infectious disease, and we are fortunate to have them as
advisors. They provided expert clinical advice on all of our
developing technologies, and we look forward to receiving their
expertise and guidance as we progress."
Clinical Investigator Meeting
Citius held an
investigator meeting in Washington D.C. An update on the
comprehensive Mino-Lok Phase III trial was provided by the Company
to a set of principle investigators and their staff. Among those in
attendance were clinical investigators from Mass General Hospital,
William Beaumont Hospital, M.D. Anderson Cancer Center, and
others.
Myron Holubiak reported, "We are
making good progress with our Mino-Lok Phase III trial and expect
to soon approach our interim analysis milestone. The consensus of
the attendees confirms our belief that Mino-Lok has the potential
to change the standard of care and would be a welcome addition for
the adjunctive treatment of central line associated blood stream
infections (CLABSIs)."
Symposium "Advances in the Prevention and Management of
CLABSI and Device-Related Infections (DRI)"
A symposium was
held on the following topics:
- The epidemiology, pathogenesis, and risk factors for CLABSI and
DRI in various risk groups
- A review of collaborative studies, interventions, and efforts
to improve the prevention and management of CBSI and DRI
- Effective strategies for the prevention and treatment of CLABSI
and DRI
Dr. Ray Hachem, MD, FIDSA,
Chaired the program and Dr. Anne-Marie Chaftari, MD and Dr.
Issam Raad were featured speakers.
The symposia provided a forum for a lively discussion on
critical issues associated with device-associated infections and
underscored the need for the development of new technologies to
address their prevention and treatment.
Mr. Holubiak continued, "There is a surprisingly high-incidence
of device-related infections that can be devastating to patients
and often prove very costly to our healthcare system. Citius is
committed to developing solutions to address this problem. Also
with the recent $7 million capital
raise, $2.5 million of which was
contributed by Company management, the Company is in better
financial condition to advance our Mino-Lok and Mino-Wrap
solutions."
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 Mino-Lok®
Mino-Lok® 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).
Mino-Lok® is under investigation and not approved for
commercial use.
About Mino-Wrap
Mino-Wrap is a novel approach to
reducing post-operative infections associated with surgical
implants. Mino-Wrap is a liquefying gel-based wrap containing
minocycline and rifampin for reducing tissue expander (TE)
infections following breast reconstructive surgeries. It is a
laminate film comprised of porcine gelatin plasticized with
glycerol. Mino-Wrap also contains the antibiotics minocycline
and rifampin to reduce bacterial bioburden on implantable devices
preventing colonization over a sustained period of time. In
the setting of breast reconstruction, Mino-Wrap provides more
durable antimicrobial protection of the implant-tissue interface
than peri-operative irrigation with antibiotic solutions (the
current standard of care). Both porcine gelatin (and
collagen) as well as the combination of minocycline and rifampin
have long histories of successful medical use in implantable
devices in multiple anatomical settings.
IDWeek
IDWeek is the combined annual meeting of the
Infectious Diseases Society of America (IDSA), the Society for
Healthcare Epidemiology of America (SHEA), the HIV Medicine
Association (HIVMA), and the Pediatric Infectious Diseases Society
(PIDS).
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 our Phase 3 trial for Mino-Lok,
including completing patient enrollment and opening study sites;
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; the
estimated markets for our product candidates and the acceptance
thereof by any market; 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; 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) 908-967-6677 x105
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.