Preclinical studies suggest that taurolidine has a direct and selective antineoplastic effect on glial and neuronal brain tumor cells. In addition, taurolidine has been shown to significantly enhance the activity of cytotoxic cancer drugs, including vincristine.
In 2016, CorMedix announced a collaboration with the Pediatric Oncology Therapeutic Investigators Consortium (POETIC) to evaluate a novel formulation of taurolidine (CMDX-001) as a part of an investigational therapy for rare pediatric cancers including neuroblastoma and osteosarcoma.
CorMedix and POETIC are advancing this program through preclinical studies and will determine a potential clinical strategy once in vivo proof-of-concept is achieved.
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. In February 2018, FDA granted Orphan Drug Designation of taurolidine for the treatment of neuroblastoma.
Taurolidine’s antimicrobial and anti-inflammatory properties may add significant value for the medical device market. CorMedix is focusing its research and development efforts on the following areas, each of which represent large markets where the company believes taurolidine-based products can achieve significant market share upon clearance by the U.S. Food and Drug Administration (FDA).
Protect exposed skin from infection
Prevent infection in common burns and diabetic foot ulcers
Prevent infection in hernia repair and burns
Initial in vitro studies have generated encouraging data and work is ongoing to achieve in vivo proof-of-concept in animal models. CorMedix also received a grant from the National Institutes of Health to develop an advanced nanoparticle formulation of taurolidine hydrogels for use as a deeper-penetrating antimicrobial for severe burn injury. The company anticipates pursuing approval of its medical device products under the accelerated and cost-efficient 510(k) device pathway, and will seek to establish commercial partnerships upon potential U.S. Food and Drug Administration (FDA) clearance.