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Goal of FDA approval for simultaneous clinical trials in multiple countries within this year

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    2022-06-21/dd>

Rznomics announced on the 21st that it has received approval from the Ministry of Food and Drug Safety for phase 1 and 2a clinical trials of "RZ-001", which is being developed as a primary liver cancer treatment.


Phase 1 for safety verification and phase 2a for effectiveness search were designed to be implemented in one clinical trial.


Rznomics has a platform technology that can remove targeted RNA using RNA trans-splicing ribozyme while expressing the desired gene.


This platform was also applied to RZ-001. It is explained that it targets telomerase (hTER) RNA, which is specifically expressed in cancer cells, to secure safety and at the same time to express genes that induce anticancer action. In this process, it is said to induce immune cells in the body, causing triple anticancer effects.


Rznomics plans to perform multinational clinical trials after obtaining approval from the U.S. Food and Drug Administration (FDA) for the same clinical design in the second half of this year. In Korea, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Seoul St. Mary's Hospital and Kyungpook National University Hospital will participate as clinical trial institutions.


Seong-wook, Lee, CEO of Rznomics, said, "It is a monumental task to administer a treatment substance using RNA trans-splicing ribozyme technology to primary liver cancer patients for the first time," adding, "We will do our best to provide new treatment opportunities to patients in need of anti-cancer treatment."


Rznomics is also promoting the expansion of indications to various cancer types. In the case of malignant glioblastoma, it is planned to enter the clinical stage within this year.