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Phio Pharmaceuticals Announces Positive DMC Recommendation and Continued Enrollment of Advanced Melanoma Study Without Modification
MARLBOROUGH, Mass., Feb. 10, 2023 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™
About this update from Phio Pharmaceuticals Corp.
[{"type":"text","content":"MARLBOROUGH, Mass., Feb. 10, 2023 /PRNewswire/ -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), 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.\nLogo - https://mma.prnewswire.com/media/786567/Phio_Pharmaceuticals_Logo.jpg\nFollowing 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.\n\"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.\nIn addition to the Phase 1b study in France, Phio expects to commence a US Phase 1b clinical trial focusing on the treatment of cutaneous squamous cell carcinoma (cSCC) and other selected cutaneous malignancies, early in the 2nd half of 2023. \nAbout the Phase 1b Trial in Advanced Melanoma\nThe Phase 1b trial is an open-label, dose escalation trial that is expected to enroll up to 21 patients with advanced melanoma. PH-762 will be administered as a neoadjuvant monotherapy intratumorally once a week, for a total of four injections, across five dose levels which are normalized to tumor volume. Dosing will be followed by tumoral excision after an additional...