FDA approves registration of STELFONTA?
STELFONTA (tigilanol tiglate injection) is now approved by the U.S. Food and Drug Administration?s Center for Veterinary Medicine for the treatment of non-metastatic mast cell tumours (MCT) in dogs, making it the first pharmaceutical treatment available for all grades of canine non-metastatic MCT1
- FDA approval follows the early 2020 marketing authorisation of STELFONTA by the European Medicines Agency, the Veterinary Medicines Directorate in the United Kingdom and Swissmedic, then subsequent sales in all major markets across Europe
- Approval for STELFONTA is based on a full data package supporting its safety, efficacy and manufacture. This included a QBiotics sponsored, pivotal, multi centre, randomised, blinded and untreated control study in 123 canine patients with MCT where 75% of canine patients achieved complete tumour resolution (?Complete Response?) after a single treatment of STELFONTA.2
- STELFONTA will be launched with U.S. veterinary oncologists in the coming months, and then made available to primary care veterinarians from early 2021 via QBiotics? marketing and distribution partner, the global animal health company Virbac
- QBiotics is also currently investigating tigilanol tiglate, the active pharmaceutical ingredient in STELFONTA, in a series of human Phase I and II clinical trials targeting solid tumours as both a monotherapy and an immune checkpoint inhibitor combination therapy.
ABOUT QBIOTICS
QBiotics is a public unlisted Australian life sciences company which discovers, develops and commercialises novel anticancer and wound healing products for human and veterinary markets. The company?s lead product, tigilanol tiglate, is an anticancer pharmaceutical targeting a range of solid tumours across multiple species. QBiotics? business model is to develop products that have application in both veterinary and human markets. Success in the veterinary programs validates QBiotics technology and de-risks human development, while generating early, non-dilutive revenues. https://qbiotics.com?? | ??https://stelfonta.com- FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
- A Multicenter, Randomized, Sham-controlled, Investigator- and Owner-masked, Pivotal Safety and Efficacy Study of Intratumoural EBC-46 in the Treatment of Canine Cutaneous and Lower Limb Subcutaneous Mast Cell Tumours. QBiotics Group Ltd., Study ID: PN1894. Published as De Ridder et al., 2020. Randomized controlled clinical study evaluating the efficacy and safety of intratumoural treatment of canine mast cell tumours with tigilanol tiglate (EBC-46). J Vet Intern Med. 2020;1?15.
- Garrett, LD. 2014. Canine mast cell tumours: diagnosis, treatment, and prognosis. Veterinary Medicine: Research and Reports, Vol 5.
- Boyle G et al. 2014. Intra-lesional Injection of the Novel PKC Activator EBC-46 Rapidly Ablates Tumours in Mouse Models, PLOS ONE, Vol 9, Issue 10