Phio Pharmaceuticals Announces Positive DMC Recommendation and Continued Enrollment of Advanced Melanoma Study Without Modification
Phio Pharmaceuticals, a clinical-stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today announced that an independent Data Monitoring Committee (DMC) completed its prespecified review of interim safety data in the Company’s Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma. The trial is ongoing at the Gustave Roussy Institute (Villejuif, France), one of the largest cancer centers in Europe. PH-762 is an INTASYL compound that reduces the expression of cell death Protein 1 (PD-1), a protein that inhibits T cells’ ability to kill cancer cells. Decreasing the expression of PD-1 increases the capacity of T cells to kill cancer cells.
Following completion of the treatment period through excision of the tumor, safety data from the initial cohort of three subjects in the Phase 1 trial was evaluated by the DMC. The safety data review disclosed no dose-limiting toxicity, and no drug-related severe adverse events or serious adverse events, and the DMC recommended proceeding to the enrollment of the subsequent dose cohort, as intended per the study protocol.
“We are pleased with the recommendation of the DMC as a reflection of the favorable safety and tolerability profile of PH-762 to date, and will continue to obtain additional safety data as well as evidence of pharmacologic effect as we develop PH-762 for advanced cutaneous tumors,” said Robert Bitterman, Phio’s Principal Executive Officer and Executive Chairman.
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