Mino-Wrap to be Developed Through an IND Process

Citius Pharmaceuticals, Inc. recently 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 US 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 (eg, fast-track and priority review).

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.

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%.

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, visit www.citiuspharma.com.