Candidate for Rznomics Glioblastoma Treatment, Approved FDA Expanded Access Program

Available to critically ill patients prior to authorization
Expect to gain more patient data


A gene therapy drug-based anticancer drug being developed by Rznomics can be used for humanitarian purposes to critically ill patients prior to approval.

Rznomics announced on the 14th that its candidate "RZ-001" has been approved for sympathetic use (EAP) by the U.S. Food and Drug Administration (FDA).


EAP refers to a system that provides humanitarian assistance to patients in critical condition for new drugs that are in the clinical trial stage prior to approval. RZ-001 can be used in patients with glioblastoma in critical condition thanks to this approval.

Rznomics is conducting phase 1/2a clinical trial on patients with glioblastoma after obtaining approval for clinical plan (IND) from the Food and Drug Administration and the FDA. "We expect that we will be able to secure more patient data through this EAP," a company source said. RZ-001 was also designated as a fast track by the FDA in November last year.

Glioblastoma is a carcinoma that occurs in the brain and has a survival period of less than a year in case of recurrence, which is a disease that has very high medical demand. On the other hand, it is considered a representative refractory tumor with insufficient treatment methods.


"We plan to expand the target hospitals starting with Harvard University Hospital, reflecting the high interest of U.S. researchers in RZ-001's EAP," said Sung-woo Hong, vice president of Rznomics. "This program is expected to have positive results in terms of effectiveness as it can apply high-concentration test drugs immediately."

Seong-wook Lee, CEO of Rznomics, said, "We hope that it will be a good treatment alternative for patients who are difficult to treat with existing drugs. We will do our best to get permission quickly through efficient clinical development."