Phio Pharmaceuticals Announces Positive Safety Monitoring Committee Recommendation to Advance INTASYL® PH-762 Skin Cancer Study to Fourth Dose Escalation Cohort

On April 9, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL siRNA gene silencing technology to eliminate cancer, reported that the Safety Monitoring Committee (SMC) recommended dose escalation in Phio’s Phase 1b clinical trial (NCT 06014086) for Phio’s lead product candidate, PH-762 (Press release, Phio Pharmaceuticals, APR 9, 2025, View Source [SID1234651854]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Phio’s Phase 1b clinical trial is a multi-center, dose-escalating trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This trial assesses the tumor response and determines the recommended dose for further study of PH-762. In the third cohort of this trial, three patients with cutaneous squamous cell carcinoma were enrolled. For these patients, injections were well tolerated with no serious adverse events and there were no dose-limiting toxicities. Pathology results related to efficacy of PH-762 in the third cohort are forthcoming.

"We are impressed with the continuing safety profile of PH-762 having now progressed through the first 3 escalating doses," said Mary Spellman, MD, Phio’s acting Chief Medical Officer.

Previously, seven patients diagnosed with cutaneous carcinomas were treated in dose cohorts 1 and 2. The second cohort enrolled a total of 4 patients who were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision) in the second cohort, two patients had a complete response (100% tumor clearance), and one patient had a partial response (90% clearance). All three patients in cohort 1 and one patient in cohort 2 maintained stable disease.

"We are optimistic that the clinical trial will continue to demonstrate that PH-762 may present a viable non-surgical alternative to existing modes of therapy for skin cancer" said Robert Bitterman, President and CEO of Phio Pharmaceuticals.