NBM-BMX / NatureWise Biotech & Medicals Corp - LARVOL DELTA

FDA Grants Orphan Drug Designation to NBM-BMX for Uveal Melanoma (NovelWise Press Release)

Orphan drug • Uveal Melanoma

NovelWise Pharmaceutical Corporation…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for NBM-BMX, a selective HDAC8 inhibitor, for the treatment of metastatic uveal melanoma (mUM) (NovelWise Press Release) - "The designation was granted based on preclinical data in uveal melanoma models, as well as safety and dose information from previous Phase I clinical studies...NovelWise plans to initiate site initiation visits (SIVs) by late 2025, followed by a Phase Ib/II clinical trial evaluating NBM-BMX as monotherapy in patients with metastatic uveal melanoma."

Fast track • Trial status • Uveal Melanoma

NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma (clinicaltrials.gov) - P1/2 | N=79 | Recruiting | Sponsor: NatureWise Biotech & Medicals Corporation

Combination therapy • Monotherapy • New P1/2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor