Phio Pharmaceuticals Announces Significant Step Forward in its Drug Development Program for PH-762

Core Insights - Phio Pharmaceuticals Corp. has received FDA acceptance for a nonclinical protocol study design, marking a significant advancement in the drug development pathway for PH-762, a treatment for skin cancer [1][3] - The company plans to commence a toxicology study in the first quarter of 2026, which is a prerequisite for initiating human pivotal trials [1] - Positive interim results from an ongoing Phase 1b clinical trial of PH-762 show promising safety and efficacy, with no dose-limiting toxicities reported [2] Group 1: Drug Development Progress - The FDA has accepted the nonclinical protocol study design for PH-762, allowing the company to move forward with necessary studies [1][3] - A toxicology study is set to begin in Q1 2026, which is essential for progressing to human trials [1] - The company is also working on delivering a commercially viable drug product by 2026, adhering to FDA's Good Manufacturing Practices [1][3] Group 2: Clinical Trial Results - The Phase 1b trial has treated 18 patients with cutaneous carcinomas, showing a cumulative pathologic response in 16 patients, including six with complete response (100% clearance) [2] - No patients exhibited clinical progression of disease during the trial, and PH-762 was well tolerated across all dose cohorts [2] - The trial results indicate a promising safety profile, with no dose-limiting toxicities or clinically relevant adverse effects reported [2] Group 3: Company Overview - Phio Pharmaceuticals Corp. is focused on developing therapeutics using its proprietary INTASYL® gene silencing technology, particularly in the field of immuno-oncology [4] - The lead clinical program, PH-762, targets the PD-1 gene associated with various skin cancers, positioning it as a potential non-surgical treatment option [4] - The ongoing Phase 1b trial is evaluating PH-762 for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [4]