Phio Pharmaceuticals Announces Regulatory Clearance of Clinical Trial for PH-762 to Treat Melanoma
MARLBOROUGH, Mass., Jan. 11, 2022 -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL™) therapeutic platform, today announced that it has received regulatory clearance to start a clinical trial with its lead product candidate, PH-762. The Company was granted the clinical trial authorization (CTA) by the French National Agency for the Safety of Medicines and Health Products (ANSM - L'Agence nationale de sécurité du médicament et des produits de santé) to proceed with a first-in-human clinical trial for PH-762 to treat patients with melanoma at the Gustave Roussy Institute. The Company expects to dose the first patient in the first quarter of 2022.
"Receiving this clinical trial authorization is an important milestone for Phio as it is the first clinical study of a new generation of immuno-oncology therapeutics based on our INTASYL self-delivering RNAi platform," said Dr. Gerrit Dispersyn, President and CEO of Phio. "This milestone is the first of several planned for this year, as we continue to accelerate our development of our clinical and preclinical product candidates."
PH-762 activates immune cells to better recognize and kill cancer cells. It does so by reducing the expression of PD-1, a clinically validated target for immunotherapy. PD-1 is expressed by T cells and prevents them from killing other cells, including cancer cells. Therefore, reducing PD-1 expression can reduce the ability of cancer cells to evade T cell detection and killing. In preclinical studies, PH-762 has demonstrated robust and durable efficacy in various in vivo tumor models, and importantly has shown that it can elicit an abscopal effect or systemic immune response after local administration.
The Company's first clinical trial with PH-762 will be a Phase 1b study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of PH-762 in a neoadjuvant setting in subjects with advanced melanoma. There are currently no neoadjuvant treatment options approved for these patients. The study features a dose escalation of PH-762 monotherapy and is designed to allow for a data driven evaluation of the recommended Phase 2 dose.
About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical stage biotechnology company developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi (INTASYL™) therapeutic platform. The Company's efforts are focused on silencing tumor-induced suppression of the immune system through its proprietary INTASYL platform with utility in immune cells and the tumor micro-environment. Our goal is to develop powerful INTASYL therapeutic compounds that can weaponize immune effector cells to overcome tumor immune escape, thereby providing patients a powerful new treatment option that goes beyond current treatment modalities. For additional information, visit the Company's website, www.phiopharma.com.
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Ashley R. Robinson
SOURCE Phio Pharmaceuticals Corp.