PRD-101 / PharmaResearch - LARVOL DELTA

PharmaResearch said on the 6th that the investigational new drug (IND) application for a phase 1 clinical trial of its next-generation nano anticancer drug ’PRD-101’ has been approved by the U.S. Food and Drug Administration (FDA) (Chosun Biz) - "PRD-101 is a nano anticancer drug that applies nucleotides manufactured with PharmaResearch's proprietary patented DNA Optimization Technology (DOT) to an anticancer formulation....The phase 1 trial will be conducted at up to seven medical institutions in the United States with about 90 patients with locally advanced or metastatic solid tumors. The trial will verify PRD-101 step by step, focusing on safety, tolerability, and pharmacokinetic characteristics."

IND • New P1 trial • Solid Tumor

PharmaResearch Receives U.S. FDA Clearance to Initiate Phase 1 Clinical Trial of Nano Anticancer Drug, PRD-101 (PRNewswire) - "The Phase 1 clinical trial will be conducted across up to seven clinical sites in the United States and is expected to enroll approximately 90 patients with locally advanced or metastatic solid tumors. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of PRD-101."

IND • New P1 trial • Solid Tumor