Phio Pharmaceuticals Corp. announced on May 7, 2025, positive pathology results for the third dose cohort in its INTASYL PH-762 skin cancer clinical trial. A complete pathologic response, indicating 100% tumor clearance, was reported for two of three patients with cutaneous squamous cell carcinoma (cSCC) treated in this cohort. The third patient was reported as having a pathologic non-response, with less than 50% tumor clearance.
Cumulatively, across cohorts 1, 2, and 3, a total of 10 patients with cutaneous carcinomas have been treated, including 9 cSCC patients and 1 metastatic melanoma patient. Of the 9 cSCC patients, four achieved a pathologic complete response, one a near complete response (>90% clearance), and one a partial response (>50% clearance). The remaining three cSCC patients and the melanoma patient had a pathologic non-response.
The company reported no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in patients receiving intratumoral PH-762, with the compound being well tolerated across all escalating dose cohorts. The fourth cohort is currently enrolling patients, and Phio expects to complete enrollment in the trial in the third quarter of 2025. Robert Bitterman, President and CEO, stated that these positive outcomes continue to indicate PH-762 may present a viable non-surgical alternative in the expanding skin cancer market.
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