CRANFORD, N.J., July 30, 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 the Company's
decision to develop Mino-Wrap as a drug through the Investigational
New Drug ("IND") process. The FDA's IND program is the means by
which a pharmaceutical company obtains permission to start human
clinical trials and to ship an experimental drug across state lines
before a marketing application for the drug has been approved.
"Mino-Wrap is a combination product that is designed to provide
both a cushioning element between the tissue expander ("TE") and
surrounding tissue reducing post-surgical inflammation, and to
prevent colonization of the surgical pocket and the TE device
following mastectomy," said Mr. Myron
Holubiak, President and CEO of Citius Pharmaceuticals.
"We have had extensive interactions with the FDA's Center for
Devices and Radiological Health Devices ("CDRH") and have decided
that we should follow the Center for Drug Evaluation and Research
("CDER") IND route. This decision was made based on the Mino-Wrap's
primary mode of action ("PMOA") which is to reduce microbial
colonization and infection. We plan to communicate further
developments in the Mino-Wrap program after we secure and have a
pre-IND meeting with FDA."
The target patient population in the U.S. is approximately
100,000 women. Citius will also be exploring a designation as
an "Orphan Drug" with the Office of Orphan Products Development
("OOPD"). The Company also intends to apply for a Qualified
Infectious Disease Product ("QIDP") designation for antibacterial
drug candidates intended to treat serious or life-threatening
infections and to take advantage of expediting mechanisms (e.g.,
fast-track and priority review).
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.
Tissue Expanders and Infection Risk
A common breast
reconstruction technique is tissue expansion, which involves
expansion of the breast skin and muscle using a temporary tissue
expander. After a few months, the expander is removed and the
patient receives either microvascular flap reconstruction, or the
insertion of a permanent breast implant. This type of breast
reconstruction requires two separate operations. A breast
tissue expander is an inflatable breast implant designed to stretch
the skin and muscle to make room for a future, more permanent
implant. Through a tiny valve mechanism located inside the
expander, saline is periodically injected to gradually fill the
expander over several weeks or months. The process usually begins
three to four weeks after mastectomy. After the skin over the
breast area has stretched enough, the expander is removed in a
second operation and either flap reconstruction or a permanent
implant is inserted. Infection is one of the most common
complications of tissue expanders and implants during breast
reconstruction, with an infection rate ranging from 2.5 to 24
percent.
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 associated with
developing Mino-Wrap, including that preclinical results may not be
predictive of clinical results and our ability to file an IND; the
estimated markets for our product candidates and the acceptance
thereof by any market; risks related to our growth strategy; risks
associated with conducting our Phase 3 trial for Mino-Lok,
including completing patient enrollment and opening study sites;
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.
Contact:
Andrew Scott
Vice President, Corporate Development
(O) 908-967-6677 x105
ascott@citiuspharma.com
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SOURCE Citius Pharmaceuticals, Inc.