The U.S. FDA has granted Alpheus Medical Inc. orphan drug and fast track designations for a therapeutic platform that could improve outcomes for patients suffering from recurrent glioblastoma (GBM), the most common primary brain cancer and among the hardest to treat.

The U.S. FDA has given Sonalasense Inc. a green light to conduct two clinical trials in life-threatening brain tumors using sonodynamic therapy (SDT) and SONALA-001, an intravenous proprietary formulation of 5-aminolevulinic acid, or ALA. The studies – in diffuse intrinsic pontine glioma (DIPG) and recurrent glioblastoma (rGBM) – mark the first time SDT will have been used in clinical trials.

Sonalasense Inc., a company working in the field of sonodynamic therapy, is collaborating with the Ivy Brain Tumor Center at Barrow Neurological Institute to conduct a first-in-human clinical trial of its noninvasive sonodynamic therapy for the treatment of recurrent glioblastoma multiforme (rGBM). The sonodynamic platform technology uses a dual approach with aminolevulinic acid (ALA) and MRI-guided focused ultrasound to target glioblastoma cells for destruction.