Citius Licenses Mino-Wrap From MD Anderson Cancer Center
Updated: Jan 28, 2019
New technology designed to reduce infections after implantation of devices
First target is breast tissue expanders
Intended for minimizing serious complications of post-operative infections associated with implants
Expands relationship with the world's top rated cancer center
CRANFORD, N.J., Jan. 8, 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 that a definitive license agreement has been reached with MD Anderson Cancer Center ("MDACC") to develop and commercialize a novel approach to reducing post-operative infections associated with surgical implants. The initial product called "Mino-Wrap", or CITI 101, is a liquefying gel-based wrap containing minocycline and rifampin for reducing tissue expander (TE) infections following breast reconstructive surgeries.
There are approximately 100,000 patients in the U.S. undergoing breast reconstruction procedures following mastectomies. Approximate 80% of the time, a tissue expander (TE) is used to prepare the surgical site for breast implants either immediately after mastectomy or in a separate procedure afterwards. A TE is a silicone implant that serves as a temporary device that is placed within a surgical pocket in the mastectomy space and inflated with saline over a period of time to prepare the area for a permanent breast implant. There is a reported rate of TE-related infections of between 2.5% and 24%, depending on the extent of surgery, duration of post-operative drainage and many other factors. TE infections frequently require removal of the TE, treatment with culture-directed antibiotics, and could result in further complications for the patient.
Scientists and physicians at MDACC have developed a bioabsorbable, antimicrobial solid film wrap that would be placed in the surgical pocket to prevent infections over a sustained period of time providing protection over longer durations than irrigation with antibiotic solutions. Studies have been performed to assess the duration of antimicrobial efficacy and potential cytotoxic adverse effects that could impact healing in the surgical pocket. Complete inhibition of bacterial biofilm formation was shown against all Gram-positive and Gram-negative organisms. This limited study indicates Mino-Wrap was efficacious at preventing bacterial growth on silicone surfaces. The antimicrobial efficacy persisted for the full 10 days during which challenges were performed; this time period corresponds to the length of time drains are usually used and represents the time of greatest risk for infection. The challenges consisted of attempted inoculations of MRSA, MRSE and Pseudomonas aeruginosa, among the most difficult-to-treat organisms in these infections.
"We are extremely pleased that Citius was able to secure the worldwide license for CITI 101, and to continue collaborating with MDACC, one of world's most respected cancer centers, in developing innovative products that address critical medical needs. Mino-Wrap is another example of utilizing existing active pharmaceutical ingredients and applying these to new indications. We have been exploring the unique properties of minocycline in both Mino-Wrap and Mino-Lok® which is currently in phase 3 trials. We will be working with the FDA to determine what regulatory pathway is appropriate to evaluate CITI 101 through its development stages," said Mr. Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We hope to be able to communicate further positive developments on this promising project in the near future."