Phio Pharmaceuticals Corp., a clinical-level siRNA biopharmaceutical company establishing a therapeutic game with its exclusive INTASYL® gene silencing technology to treat cancer, has completed its enrolment process in the Phase 1b clinical trial. It’s a clinical trial of INTASYL siRNA, a popular compound, PH-762. With this ongoing trial and the completion of the enrolment round, the company is also leading in treating the additional patient population queued in the fifth cohort at the peak dose concentration of PH-762.
These patients’ pathology results are predicted to be declared in Q1 2026. The PH-762 is a potential silencer of the PD-1 gene found in numerous forms of skin cancer.
The Phase 1b clinical trial is engineered to examine the tolerability and safety volume of neoadjuvant implication of intratumoral PH-762 in total 3 stages (1,2, and 4) cutaneous squamous cell carcinoma (cSCC), Stage 4 Merkel cell carcinoma and Stage 4 melanoma. According to the trial's protocol, the patient cohort will receive four injections will be received of PH-762 on a weekly basis pathologic responses and intervals to be examined on day 36 after the first injection of PH-762 (NCT#06014086).
Till now, around 18 cutaneous carcinomas patients have received the treatment throughout the five-dose escalating groups in the Phase 1b trial. Totally, 16 patients’ aggregate pathologic response rate with cSCC involving 2 with a nearly complete response, 2 with a partial response and six with a complete response were found precisely. One patient with metastatic Merkel cell carcinoma showed a partial response, whereas one patient with metastatic melanoma and six with cSCC showed a pathologic non-response rate.
With this, it's clear that as of now, no patients in the study have demonstrated the clinical progression of disease. Till now, there have been no such clinically suitable emergent negative effects and dose-limiting toxicities in the patients taking intratumoral PH-762 during this trial. The PH-762 has shown immense tolerability in every enrolled patient in every escalating dose group.
The Chairman and CEO of the Board, Phio Pharmaceuticals, Robert Bitterman, said, “The completion of the enrolment in the Phase 1b trial for PH-762 represents a meaningful step towards a beneficial committed treatment alternative for skin cancer. We are very thankful to all the investigators, our partners, team and patients for joining hands with us and helping us reach to another successful milestone.”