Benzinga | Aug 4, 2020 08:19AM EDT

Citius Submits Mino-Wrap Briefing Package To FDA For Pre-IND Consult

CRANFORD, N.J., Aug. 4, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products announced progress in the development of Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants.

Mino-Wrap is a gel-containing minocycline and rifampin film that is used to wrap the tissue expander ("TE") used in breast reconstructive surgeries. In order to stimulate early consultation and potentially speed the development of Mino-Wrap, the company has submitted a briefing package to the FDA Division of Anti-Infective Products. The briefing package contains 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 company will consider the feedback provided by the FDA in the development of the Pre-IND. There is no set timeline for FDA to respond to a consultation package; however, based on pre-COVID-19 experience, we expect a response from FDA within 60 days.

Mino-Wrap also marks the second collaboration with MD Anderson Cancer Center ("MDACC") who are the inventors of this novel approach to preventing post-mastectomy infections when tissue expanders are used. The Company is currently developing Mino-Lok(r), an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), in collaboration with MDACC. Mino-Lok is in phase 3 development.

"The published rate of infection for tissue expanders used in breast reconstructive surgery is between 2.5 % and 24%, with an estimated mean at around 12% to 14%. 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 also are extremely honored to be working with the doctors and scientists at MD Anderson Cancer Center to develop another much-needed improvement in adjunctive cancer care. The early consultation with FDA allows for the identification of optimal strategies for our preclinical and clinical development programs. We are pleased to be taking advantage of this collaborative approach with the agency."