FDA grants fast track, orphan drug designations to glioblastoma therapy


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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.


FDA building



“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 Schulder, MD, director of the Brain Tumor Center and primary investigator for the clinical trial at Northwell Health’s Institute for Neurology and Neurosurgery, said in an Alpheus Medical press release.

The investigational treatment is a noninvasive drug-device combination that targets cancer cells throughout the entire hemisphere using low-intensity, diffuse ultrasound, according to the press release. The sonodynamic therapy is administered in an outpatient setting and does not require imaging.

“The FDA fast track and orphan drug Designations are significant milestones and highlight the importance of innovation within the field of brain cancer,” Vijay Agarwal, MD, founder and CEO of Alpheus Medical, said in the release. “Built on a very successful preclinical program, we believe our proprietary [sonodynamic therapy] platform is a game changer and has the potential to significantly advance the treatment of gliomas.”

Fast track designation is designed to facilitate the development and advance the review of drugs that treat serious conditions and fill an unmet medical need.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

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