Rznomics, Application for clinical trial IND to FDA

  • 작성자
  • 날짜

Rznomics announced on the 9th that it has applied to the U.S. Food and Drug Administration (FDA) for a phase 1/2a clinical trial of the hepatocellular cancer therapy "RZ-001".

It is an extension of the domestic clinical trial that was approved by the Ministry of Food and Drug Safety in June and is being submitted for the originally planned multinational clinical trial.

Based on RNA trans-splicing ribozyme, Rznomics is developing a technology that removes target RNA and simultaneously expresses the desired gene.

RZ-001 is a mechanism that targets the telomerase (hTER) RNA that is specifically expressed by cancer cells by transferring ribonucleic acid substitution enzymes through the adenovirus vector and expresses genes that induce anticancer action.

Rznomics is also pushing to expand indications to other cancer species, and especially plans to perform clinical trials on malignant glioblastoma within this year.

In addition to the anticancer drug pipeline, it is developing therapy in various fields using platform technologies such as Alzheimer's therapies, hereditary retinopathy, and Rett’s syndrome.

Genetic retinal pigmentosa was registered with the Korean Intellectual Property Office in May, followed by a notification of the registration decision from the U.S. Patent Office in August to prove its technological progress, the company added.

Seong-wook, Lee, CEO of Rznomics, said, "The pipelines under development will be launched sequentially at home and abroad, and we will do our best to provide patients with new therapy opportunities."