Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced that it has expanded the intellectual property associated with its global license agreement with the MD Anderson Cancer Center ("MDACC"). Through this license agreement, Citius is developing Mino-Wrap, which is a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander ("TE").
The United States Patent and Trademark Office (USPTO) has issued patent 10,434,221 B2 and patent application publication US 2019/0388591 A1, both continuations of the initial patent for "Antimicrobial Wraps for Medical Implants".
The intellectual property expansion was granted to The Board of Regents of The University of Texas System on behalf of The University of Texas M. D. Anderson Cancer Center and enhances the design and use of Mino-Wrap.
"The frequency of post-mastectomy breast reconstruction, following breast cancer treatment, has been increasing on an annual basis. There are over 100,000 patients in the U.S. undergoing breast reconstruction procedures following mastectomies and approximately 80% of the time, a TE is used to prepare the surgical site for breast implants either immediately after mastectomy or in a separate procedure afterwards. The published rate of infection for TEs used in breast reconstructive surgery is between 2.5 % and 24%, with an estimated mean at around 12% to 14%. These data points are concerning and not well understood. Through our agreement with MDACC, we believe Mino-Wrap has the potential to provide a significant reduction in the incidence of infection, sparing the patient the pain and discomfort of extended hospitalization and further aggressive and lengthy courses of antibiotics in an attempt to salvage the TEs. In many cases the TE is removed leading to a delay in lifesaving chemo-radiation therapy, which can be a devastating consequence for the patient. " said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We are especially pleased that the claims for Mino-Wrap intellectual property are being expanded and broadened as we develop the optimal design and application."
The Company is also currently developing Mino-Lok®, an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), in collaboration with MDACC. Mino-Lok is in phase 3 development.
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.
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 MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center in Houston
ranks as one of the world's most respected centers focused on cancer
patient care, research, education and prevention. The institution's sole
mission is to end cancer for patients and their families around the
world. MD Anderson is one of only 45 comprehensive cancer centers
designated by the National Cancer Institute (NCI). MD Anderson is ranked
No.1 for cancer care in U.S. News & World Report's "Best
Hospital's" survey. It has ranked as one of the nation's top two
hospitals since the survey began in 1990, and has ranked first for 11 of
the past 14 years. MD Anderson receives a cancer center support grant
from the NCI of the National Institutes of Health (P30 CA016672).
About Mino-Lok®
Mino-Lok® is an antibiotic
lock solution being developed as an adjunctive therapy in patients with
central line-associated bloodstream infections (CLABSIs) or
catheter-related bloodstream infections (CRBSIs). CLABSIs/CRBSIs are
very serious, especially in cancer patients receiving therapy through
central venous catheters (CVCs) and in hemodialysis patients, for whom
venous access presents a challenge. There are currently no approved
therapies for salvaging infected CVCs.
No comments:
Post a Comment