Phio Pharmaceuticals has received approval for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to commence a clinical trial of PH-762 to treat skin carcinomas.
An INTASYL compound, PH-762 reduces the expression of cell death Protein 1 (PD-1) that inhibits the ability of T cells to kill cancer cells.
The company intends to commence the Phase Ib clinical trial of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, and Merkel cell patients in the second half of this year.
Phio Pharmaceuticals president and CEO Robert Bitterman said: “The clearance of our IND application for PH-762 represents a significant milestone in Phio’s continued evolution from drug discovery to clinical development.”
The first dose-escalating, multi-centre Phase Ib trial has been designed for assessing the tolerability and safety of neoadjuvant use of intratumorally injected PH-762.
It will also assess PH-762’s tumour response and determine the dose or dose range for the continued trial.
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Phio Pharmaceuticals acting chief medical officer Dr Mary Spellman said: “Cutaneous malignancies may be both locally destructive and systemically devastating. We look forward to investigating this new immuno-oncology approach to treat these carcinomas.”
The company plans to complete its first-in-human clinical trial for PH-762 in France and focus its efforts on the clinical trial in the US.