PHIO Pharmaceuticals Corp. Announces FDA Acceptance of Nonclinical Protocol for PH-762

Phio Pharmaceuticals Corp. has announced a significant advancement in its drug development program for PH-762. The company's nonclinical protocol study design has been accepted by the Federal Drug Administration (FDA), paving the way for a toxicology study to commence in the first quarter of 2026. This marks a crucial step towards initiating a human pivotal trial. Concurrently, Phio is working on delivering a commercially viable drug product by 2026, adhering to FDA's current Good Manufacturing Practices, with funding from recent financing directed towards these key initiatives. The company also reported positive interim safety and efficacy results from an ongoing Phase 1b clinical trial of PH-762 for skin cancer. In this trial, 18 patients with cutaneous carcinomas were treated, with notable responses including complete clearance in six patients with cSCC and partial responses in others. No dose-limiting toxicities or significant adverse effects have been observed, and PH-762 has been well-tolerated.