FDA Grants DNX-2401 Fast Track Designation for Recurrent Glioblastoma
DNAtrix announced that the FDA has granted Fast Track status for DNX-2401, a replication competent adenovirus for patients with recurrent glioblastoma.
In a Phase 1 dose-escalating monotherapy study conducted with DNX-2401 for patients with recurrent malignant glioma, efficacy results have been extremely promising, with evidence of total tumor destruction and long-term survival in several patients. A second Phase 1 trial evaluating DNX-2401 in combination with the drug temozolomide is currently ongoing for patients with recurrent glioblastoma.
