The US Food and Drug Administration (FDA) has granted clearance for PharmaResearch’s PRD-101 investigational new drug (IND) application, enabling the commencement of a Phase I trial in the country.
PRD-101 is a nano anticancer drug formulated leveraging nucleotide fragments produced through the company’s DNA optimising technology (DOT).
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It utilises the nucleotide-based Advanced DOT drug delivery platform, with the aim of achieving efficient therapeutic loading and improved pharmacokinetics.
The Phase I clinical trial is set to be conducted at up to seven sites in the US and is expected to recruit 90 patients who have locally advanced or metastatic solid tumours.
It will evaluate the tolerability, pharmacokinetics, and safety of PRD-101.
PRD-101’s development has involved collaboration between PharmaResearch and researchers at the University of California Irvine (UCI), as well as support from organisations such as the US National Cancer Institute Nanotechnology Characterisation Laboratory (NCL).
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By GlobalDataPharmaResearch holds patents and exclusive licences related to PRD-101.
Conventional anticancer therapies frequently face limitations due to toxicity, restricting patient eligibility and requiring careful dose management. PharmaResearch anticipates that PRD-101 may contribute to addressing these unmet needs in anticancer treatment.
PharmaResearch said: “The FDA clearance of our IND application marks an important milestone for PRD-101. Through this Phase I trial, we aim to further characterise PRD-101 and continue advancing our oncology pipeline.”
PharmaResearch’s portfolio includes medical devices, medicines, supplements, and cosmetics. The company focuses on DOT polydeoxyribonucleotide (PDRN) and DOT polynucleotide (PN), both covered by patents.
It is headquartered in South Korea and has a subsidiary in Costa Mesa, California.
