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# Orphan Drug Status for EnGeneIC Tumor Drug
- URL: https://www.fdaweb.com/orphan-drug-status-for-engeneic-tumor-drug/
- Published: 2017-03-03T12:00:00.000Z
- Updated: 2026-09-14T22:09:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138118

FDA has granted EnGeneIC an orphan drug designation for its *epidermal growth factor receptor-*targeted, doxorubicin-loaded EDV nanocells for treating glioblastoma multiforme. The clinical stage biopharmaceutical company says it is focused on developing its proprietary bacterially-derived EDV nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform to directly target and kill tumor cells with minimal toxicity, while simultaneously stimulating the immune system's natural anti-tumor response. The intravenously injected EDV nanocells are designed to “exit the leaky vascular system only found within tumors and attach to cancer cells via a specially designed, targeted bi-specific antibody,” the company says. “Once attached, the nanocell is able to enter the tumor cell and deliver a drug, siRNA, or miRNA payload at high concentrations, intracellularly.” EnGeneIC is currently planning to commence further clinical trials in several cancer indications in Australia and the U.S.