PharmaResearch announced on the 6th that its next-generation nano anticancer agent under development, “PRD-101,” has received clearance for a Phase 1 clinical trial (IND) from the U.S. Food and Drug Administration (FDA).

PRD-101 is a nano anticancer agent that applies nucleotides manufactured using PharmaResearch’s patented technology (DOT) to an anticancer formulation. PharmaResearch stated that PRD-101 incorporates the “Advanced DOT” platform, an upgraded version of the DOT technology. Advanced DOT is a drug delivery platform designed to load nucleotide-based drugs, characterized by its ability to maximize bioavailability by increasing the drug’s residence time in the body.

PRD-101 was developed through collaboration between PharmaResearch and researchers at the University of California, Irvine, and has been studied and evaluated at the Nanotechnology Characterization Lab (NCL) under the U.S. National Cancer Institute (NCI).

The Phase 1 clinical trial will be conducted at seven medical institutions in the United States, targeting approximately 90 patients with locally advanced or metastatic solid tumors. The trial will focus on stepwise evaluation of the safety, tolerability, and pharmacokinetic characteristics of PRD-101.

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