Phio Pharmaceuticals Announces Positive Safety Monitoring Committee (SMC) Recommendation to continue to Third Dose Cohort in its Clinical Study of PH-762

On December 19, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage biotechnology company that develops therapeutics using its INTASYL siRNA gene silencing technology to make the body’s immune cells more effective in killing cancer cells. Phio reported that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma (Press release, Phio Pharmaceuticals, DEC 19, 2024, View Source [SID1234649220]).

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In this Phase 1b clinical study with PH-762, dosed intratumorally, the second cohort had enrolled 4 patients who were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision), the first two patients who completed treatment showed a complete response (100% tumor clearance and a partial response 90% clearance), respectively. Pathology data assessing efficacy data on the remaining 2 patients is forthcoming.

The intratumoral injections have been well tolerated. There have been no dose-limiting toxicities, or serious adverse events in participants receiving intratumoral PH-762.

"Safety and efficacy data from our clinical trial continues to be encouraging as we develop PH-762 for the treatment of cutaneous carcinomas" said Mary Spellman MD, Phio’s acting Chief Medical Officer. "We look forward to continued enrollment in the clinical study."