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).
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 company applied the technology to the oncology treatment field for the first time.
PRD-101 incorporates the drug delivery platform "Advanced DOT™," an enhanced version of the DOT® technology. Designed as a next-generation delivery technology that enables loading of nucleotide-based drugs, the platform extends a drug's residence time in the body to improve bioavailability. In preclinical studies, it showed the potential to improve toxicity and adverse reactions that have been cited as issues with existing nano anticancer drugs. The company said advantages are expected in terms of safety in oncology treatment settings that require long-term dosing.
The candidate was developed through joint research by PharmaResearch and researchers at University of California, Irvine (UCI). Research and evaluation were conducted at the Nanotechnology Characterization Laboratory (NCL) under the National Cancer Institute (NCI).
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.
A PharmaResearch official who participated in the development of PRD-101 said, "With this phase 1 approval, we have laid the groundwork to verify the safety and potential of the next-generation nano anticancer drug," adding, "Through stepwise clinical trials, we plan to identify the characteristics of PRD-101 and expand its applicability to the oncology treatment field."