#USA #California #FDA Approval #PharmaResearch #PRD-101

PharmaResearch Secures FDA Clearance for PRD-101

PharmaResearch Co., Ltd., based in South Korea, has officially announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for PRD-101, a cutting-edge nano anticancer drug. This significant milestone allows the company to commence Phase 1 clinical trials in the United States, aiming to evaluate the safety and efficacy of this novel drug in treating patients with advanced solid tumors.

What is PRD-101?

PRD-101 is designed using PharmaResearch's proprietary DNA Optimizing Technology (DOT®), which utilizes nucleotide fragments for developing efficacious nano formulations. The drug is part of the company’s Advanced DOT™ delivery platform, which improves the pharmacokinetics and delivery of therapeutics, ensuring that the anticancer agents reach their target effectively while minimizing toxicity.

The Clinical Trial Details

The Phase 1 clinical trial for PRD-101 is set to take place at seven clinical sites across the U.S., with plans to enroll approximately 90 patients suffering from locally advanced or metastatic solid tumors. This trial's primary objectives are to assess the safety, tolerability, and pharmacokinetic properties of the drug. With its innovative approach, PharmaResearch is hopeful that PRD-101 can provide new avenues for treatment where traditional therapies fall short.

A Game Changer in Cancer Therapy

One of the critical issues with conventional anticancer drugs is their high toxicity, often leading to restrictions on patient eligibility and stringent dosage management. PRD-101 intends to address these challenges by offering a safer alternative that can still effectively target cancer cells. The team at PharmaResearch believes that this drug will fulfill existing medical needs in cancer treatment, further enhancing the effectiveness of oncology therapies.

Support from Notable Institutions

The development of PRD-101 was made possible through collaborative efforts with researchers from the University of California, Irvine (UCI), as well as support provided by the U.S. National Center for Advancing Translational Sciences (NCL). Furthermore, PharmaResearch has secured patents and exclusive licenses that relate to PRD-101, marking a significant advancement in the company’s continuous pursuit of innovative solutions in biopharmaceuticals.

About PharmaResearch

PharmaResearch is a pioneering biopharmaceutical enterprise committed to enhancing the quality of life through regenerative medicine. Their diversified portfolio spans medicines, medical devices, and cosmetics, with a strong focus on integrating their patented core ingredients, including DOT® PDRN and DOT® PN. The company is headquartered in Gangneung-si, Gangwon-do, South Korea, and operates a branch in Costa Mesa, California.

With the FDA's approval of the IND for PRD-101, PharmaResearch is poised to make significant strides in the oncology field, potentially altering the landscape of cancer treatment. As these clinical trials begin, the global biomedical community will be watching closely to see the outcomes of this promising new therapy.