Rznomics said its anti-cancer gene therapy RZ-001 cleared an initial regulatory hurdle in Europe after the European Medicines Agency's Committee for Orphan Medicinal Products adopted a positive opinion on Sept. 28. The committee determined that RZ-001 meets the criteria for orphan drug designation in glioma and could provide a significant benefit despite existing treatments, citing clinical responses and sustained tumor disappearance on imaging in several patients with recurrent glioblastoma. RZ-001 is being tested in Phase 1/2a trials in South Korea and the United States among patients with telomerase (hTERT)-positive recurrent glioblastoma. European orphan designation provides access to EMA protocol assistance on clinical and regulatory strategy, as well as potential fee reductions during marketing authorization. If approved and other requirements are met, the therapy could receive up to 10 years of market exclusivity in the European Union for the rare indication. The opinion follows the U.S. Food and Drug Administration's RMAT designation for hepatocellular carcinoma in May this year, while Rznomics CEO Lee Seong-wook said the company would seek to expand indications and advance business development for RZ-001.