The key component in CorMedix’s flagship product, Neutrolin®, is taurolidine, a synthetic broad-spectrum non-antibiotic antimicrobial with anti-inflammatory and potential anti-tumor activities. Taurolidine is derived from the natural amino acid taurine and its antimicrobial activity is directed at the bacterial cell surface.
It disrupts cell walls and destroys bacterial fimbriae, which are important for colonization and biofilm formation. It also binds to and neutralizes bacterial exotoxins and endotoxins (lipopolysaccharides, LPS). Products containing taurolidine have been marketed in Europe for many years, and to date, have not shown susceptibility to bacterial resistance mechanisms, which have plagued antibiotic development.
Taurolidine also inhibits expression of key inflammatory molecules tumor necrosis factor-a and interleukin 1b. Although the mechanisms underlying its anti-tumor activity are not fully elucidated, taurolidine has been shown to inhibit new blood vessel formation within tumors and enhance cancer cell death through apoptosis, as well as reduce tumor cell adhesion.
CorMedix is conducting research to explore additional uses for taurolidine, including oncology and medical devices. The Company would look to establish strategic partnerships to advance these products once proof-of-concept is achieved.
In 2016, CorMedix entered into two exclusive research licensing agreements with NanoProteagen. The two companies will use NanoProteagen’s proprietary nanoparticle technology, NanoPro™, to test the feasibility of delivering a novel anti-cancer combination therapy consisting of CRMD-005, a proprietary formulation of taurolidine, with vincristine, a standard of care cytotoxic chemotherapy agent, to target neuroblastoma tumors.
In vitro studies indicate that taurolidine has a direct and selective antineoplastic effect on glial and neuronal brain tumor cells, and in addition, has been shown to significantly enhance the activity of cytotoxic cancer drugs, including vincristine. If feasible, the two companies intend to create a powerful therapy that selectively targets tumor cells while minimizing effects on normal cells.
Pediatric neuroblastoma, an Orphan Disease in the United States, is an adrenal cancer that develops in the nerve cells of the medulla and is the most common extracranial tumor in childhood, usually occurring in infants and children under 10.
Taurolidine’s antimicrobial and anti-inflammatory properties may add significant value for the medical device market. Preliminary research has shown that taurolidine can be coated or incorporated into a number of medical materials, and CorMedix is exploring opportunities in the following areas:
- Sutures: protect exposed skin from infection
- Topicals: treat antimicrobial-resistant skin/soft tissue infections
- Wound closure materials: support healing for complex wounds such as burns
- Gels: viscosupplementation for osteoarthritis
- Nanofiber webs: incorporation into surgical meshes; tissue engineering
- Implanted devices: antimicrobial coating or integrated into device itself
Researchers from the faculty of Weill-Cornell University Medical College presented preliminary observations gathered from in vitro tests demonstrating the ability of taurolidine-loaded suture materials to inhibit bacterial growth in the vicinity of fibers and kill clinically significant human pathogens including Pseudomonas aeruginosa, Staphylococcus epidermidis, and Staphylococcus aureus. The results suggest that integrating taurolidine into the matrix of a monofilament or multifilament sutures could reduce surgical site infections, thereby improving overall patient outcomes.
CorMedix has secured a number of provisional patents to protect its intellectual property related to taurolidine-incorporated medical devices. The Company is interested in establishing strategic partnerships to develop future products in this space.