Alpheus Medical Ultrasound Therapy Gets Orphan Drug and Fast Track Nods for Glioblastoma

The FDA has granted Alpheus Medical’s drug-device combination therapy, CV-01, Orphan Drug and Fast Track designations.

The non-invasive therapy, which targets cancer cells in the brain using low-intensity, diffuse ultrasound, will be tested in a phase 1 study, which is currently enrolling patients. CV-01 is being developed as a potential treatment for recurrent glioblastoma and other malignant gliomas that affect the nervous system.

The proprietary therapy “has the potential to significantly advance the treatment of gliomas," says Vijay Agarwal, the company’s founder and CEO, who is a practicing brain tumor surgeon.

The FDA’s Orphan Drug program is designed to support the development and evaluation of new treatments for rare diseases. The Fast Track program is designed to expedite the development and review of treatments that fill an unmet medical need.