On September 21, 2020 Fennec Pharmaceuticals Inc. (Nasdaq: FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, reported that the U.S. Patent and Trademark Office will issue U.S. Patent 10,792,363 entitled "Anhydrous Sodium Thiosulfate and Formulations Thereof (Press release, Fennec Pharmaceuticals, SEP 21, 2020, View Source [SID1234565426])." As suggested by the title, the patent captures the unique anhydrous form of the active ingredient in Fennec’s PEDMARK product, as well as related methods of synthesis. This patent is eligible for listing in the U.S Food and Drug Administration (FDA) Orange Book, and reflects Fennec’s strategy to expand and diversify its intellectual property portfolio to obtain protection for the PEDMARK product.
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PEDMARK was granted Orphan Drug Designation by the FDA in 2004. This designation, along with a patent portfolio that includes a previously issued method of use patent from March 2020 and this recent to-be-issued composition patent, further strengthens the position of PEDMARK as the first potential treatment for the prevention of platinum induced ototoxicity in pediatric patients.
About PEDMARK (A unique formulation of sodium thiosulfate (STS))
Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible and is particularly harmful to the survivors of pediatric cancer.
In the U.S. and Europe, it is estimated annually that over 10,000 children may receive platinum-based chemotherapy. The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this type of hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.
PEDMARK has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
PEDMARK received Breakthrough Therapy and Fast Track Designation by the FDA in March 2018.
The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).