PHIO - Phio Pharma's lead candidate PH-762 receives FDA clearance for clinical trial shares surge by 28%
2023-05-16 09:01:37 ET
- Phio Pharma ( NASDAQ: PHIO ) witnessed a significant premarket surge of 28% following its announcement that the U.S. Food and Drug Administration (FDA) had granted clearance for its Investigational New Drug ( IND ) application.
- This clearance paves the way for Phio to proceed with a clinical trial of its lead product candidate, PH-762.
- PH-762, an INTASYL compound developed by Phio, works by reducing the expression of PD-1—a protein known to impede the T cells' ability to effectively eliminate cancer cells. With this milestone achieved, Phio is now gearing up to launch its Phase 1b clinical trial, focusing on intratumoral administration of PH-762.
- The trial aims to evaluate the efficacy of PH-762 in patients diagnosed with cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The anticipated initiation of the trial is slated for the second half of 2023.
- The cleared IND from Phio paves the way for an initial multi-center, dose-escalating Phase 1b clinical trial. The trial aims to evaluate the safety and tolerability of intratumorally injected PH-762 as a neoadjuvant treatment, measure tumor response, and establish the optimal dosage or dose range for further investigation of PH-762.
- Phio will prioritize its U.S. clinical trial while winding down its first-in-human clinical trial for PH-762 in France. The French trial was restricted to treating patients with metastatic melanoma.
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Phio Pharma's lead candidate, PH-762, receives FDA clearance for clinical trial, shares surge by 28%