Therapy Areas: Central Nervous System
Rznomics's RZ-001receives US FDA Fast Track Designation
13 November 2023 -

Rznomics Inc, a South Korea based biopharmaceutical company, announced on Friday that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the company's RZ-001 intended for the treatment of patients with Glioblastoma (GBM).

GBM is known as the most malignant tumour in Central Nervous system with high mortality rate but lacks effective therapies. RZ-001, the RNA replacement enzyme-based cancer gene therapy for the treatment of GBM, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. This induces anti-cancer activity and cytotoxic effect by trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. The company says that RZ-001 has demonstrated very promising responses in preclinical studies in which an enhanced anti-cancer efficacy and a higher survival rate was observed.

Rznomics received Phase I/IIa IND approval for RZ-001 from the FDA and the South Korean Ministry of Food and Drug Safety (MFDS) in Glioblastoma and the clinical trial will investigate the safety, tolerability, and efficacy of RZ-001 in patients with GBM. Subjects will be treated with RZ-001 according to the planned dose escalation design.