Phase 1 Clinical Trial Using Newcastle Disease Virus (NDV) for Oncolytic Therapy of Equine Sarcoid

• Grant number: 24/11149-0
• Support Opportunities: Scholarships in Brazil - Master
• Start date: March 01, 2025
• End date: March 31, 2026
• Field of knowledge: Agronomical Sciences - Veterinary Medicine - Animal Clinics and Surgery
• Principal Investigator: Renata Gebara Sampaio Dória
• Grantee: Shéron Luma de Oliveira Gonçalves
• Host Institution: Faculdade de Zootecnia e Engenharia de Alimentos (FZEA). Universidade de São Paulo (USP). Pirassununga , SP, Brazil
• Associated research grant: 22/09378-5 - Development of innovative therapies and diagnostic tools for veterinary oncology, AP.TEM

Abstract

Sarcoids are a common cutaneous neoplasm in horses, and available treatments typically exhibit low efficacy and a high risk of recurrence. Oncolytic therapy using the Newcastle Disease Virus (NDV) has shown effectiveness in combating neoplastic cells due to its natural ability to infect cancer cells and stimulate anti-tumor immune responses. This study aims to conduct a phase 1 clinical trial using NDV-GFP as an investigational veterinary product (IVP) for intralesional applications. A randomized clinical trial will be conducted, involving 12 horses with sarcoids. The animals will be randomly divided into two groups and treated with IVP or PBS. Three intralesional applications of the treatments will be performed, with a one-week interval between them. The animals will be monitored for 5 weeks. During this period, evaluations will be made regarding physical examinations, laboratory tests, application site, tumor histopathology, quantification of antibodies against NDV, and detection of the virus systemically. At the end of the treatment, when possible, surgical resection of the tumor will be performed. Animals showing signs of toxicity, depending on the severity, will be excluded from the experiment and receive therapeutic support. It is expected that the horses will tolerate NDV-GFP therapy and that there will be changes related to tumor regression.