FDA grants fast track, orphan drug designations to glioblastoma therapy

The FDA granted fast track and orphan drug designations to Alpheus Medical’s CV-01 delivery of sonodynamic therapy for treatment of recurrent glioblastoma.
Enrollment is underway for a phase 1 trial that will evaluate the safety, optimal dosage and efficacy of the platform for patients with high-grade glioma. Researchers will enroll up to 33 patients.
“The diffuse nature of glioblastomas, often across the hemisphere, makes it an extremely challenging disease to treat. There are very few effective options, leading to poor patient outcomes and a universally fatal disease," Michael

The FDA granted fast track and orphan drug designations to Alpheus Medical’s CV-01 delivery of sonodynamic therapy for treatment of recurrent glioblastoma.
Enrollment is underway for a phase 1 trial that will evaluate the safety, optimal dosage and efficacy of the platform for patients with high-grade glioma. Researchers will enroll up to 33 patients.
“The diffuse nature of glioblastomas, often across the hemisphere, makes it an extremely challenging disease to treat. There are very few effective options, leading to poor patient outcomes and a universally fatal disease,» Michael