Alpheus Medical Gets Orphan Drug and Fast Track Nods for CV-01 in Recurrent Glioblastoma

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

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 drugs to treat serious conditions and fill an unmet medical need.