CRANFORD, N.J., Dec. 9, 2020 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a
specialty pharmaceutical company focused on developing and
commercializing critical care drug products, announced its receipt
of a written response and guidance from the U.S. Food and Drug
Administration (FDA) Division of Anti-Infective Products to the
Company's Pre-Investigational New Drug (Pre-IND) consultation
request for its Mino-Wrap briefing package. Through its
global license agreement with the The University of Texas MD Anderson Cancer Center,
Citius is developing Mino-Wrap, a novel approach to reducing
post-mastectomy infections associated with the use of a tissue
expander. The briefing package contained information regarding
pre-clinical data and a clinical development plan, along with
questions for the FDA regarding safety and efficacy data that would
be required to advance Mino-Wrap into clinical trials.
The FDA granted a Written Response Only meeting regarding
guidance and direction on the Mino-Wrap development plan. The
agency indicated that bio absorption simulation studies may provide
information to support the development of Mino-Wrap and made
suggestions on what should be provided relative to non-clinical
support. The FDA provided guidance on the design of the drug
elution studies and agreed that a large animal pharmacology study
would be appropriate. They also agreed that a 28-day
toxicology study appears appropriate and that microbiology support
through existing data is acceptable.
"The FDA provided us with valuable guidance and confirmed
a number of our initial plans on the development of Mino-Wrap,"
said Myron Holubiak, President and CEO of Citius
Pharmaceuticals. "We are very pleased to have guidance
support from the agency because this is such an under-recognized
problem, and current preventative measures have not yielded very
acceptable results. We think we have an important innovation for
the prevention of post-operative infections associated with breast
reconstructive surgery after mastectomies."
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 is designed to
provide 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.
About 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. A tissue expander is an empty breast implant that is
filled with normal saline over 6 to 8 weeks until it reaches the
breast size that is desired. In this type of reconstruction, the
surgeon will either make a pocket under a large muscle in the chest
and place a tissue expander in that space or place the expander
above the large muscle. About 4 to 8 weeks after the tissue
expansion is finished, a second surgery is required to remove the
tissue expander and insert the permanent breast implant. The
patient receives either microvascular flap reconstruction, or the
insertion of a permanent breast implant. 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
late-stage specialty pharmaceutical company dedicated to the
development and commercialization of critical care products, with a
focus on anti-infectives and cancer care. 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:
our ability to successfully undertake and complete clinical trials
and the results from those trials for Mino-Wrap; 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; the estimated markets for our product candidates and
the acceptance thereof by any market; risks related to our growth
strategy; patent and intellectual property matters, market and
other conditions; our ability to attract, integrate, and retain key
personnel; 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; government regulation; 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.