Wednesday, August 10, 2022


FDA Grants Alpheus Medical Orphan Drug and Fast Track Designations for Novel Sonodynamic Therapy for Brain Cancer

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Alpheus Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, today announced the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug and Fast Track Designations to Alpheus Medical’s CV-01 delivery of sonodynamic therapy (SDT) as a potential treatment for patients with recurrent glioblastoma, the most common primary brain cancer, and other malignant gliomas. Northwell Health’s North Shore University Hospital in Long Island, New York, is currently enrolling patients in the multi-center Phase 1 clinical trial.

The First-in-Human trial will evaluate the safety, optimal dosage, and efficacy of Alpheus’ SDT platform in patients with recurrent high-grade glioma.

“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,” commented Michael Schulder, MD, Director of the Brain Tumor Center and Primary Investigator (PI) for the clinical trial at Northwell Health’s Institute for Neurology and Neurosurgery. “Alpheus’ sonodynamic therapy enables non-invasive, diffuse treatment across the hemisphere. It has the potential to change the landscape of high-grade glioma therapy and we are excited to be part of this important study.”

Alpheus Medical’s proprietary, investigational SDT treatment is an innovative, non-invasive drug-device combination that targets cancer cells throughout the entire hemisphere using low-intensity, diffuse ultrasound. The SDT is administered in an outpatient setting and does not require imaging. The multi-center trial (NCT05362409) is designed to study the safety and optimal application of Alpheus’ SDT treatment, as well as efficacy, and is planned to enroll up to 33 patients.

“The FDA Fast Track and Orphan Drug Designations are significant milestones and highlight the importance of innovation within the field of brain cancer,” stated Dr. Vijay Agarwal, CEO and founder of Alpheus Medical and a practicing brain tumor surgeon. “Built on a very successful pre-clinical program, we believe our proprietary SDT platform is a game-changer and has the potential to significantly advance the treatment of gliomas.”

The FDA Orphan Drug and Fast Track programs are designed to facilitate the development of important new therapies and to provide patients with serious and rare conditions access to treatment more quickly. Orphan Drug status is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the U.S. It provides development incentives and post-approval marketing exclusivity for seven years.  The Fast Track designation enables early and frequent communication between FDA and product sponsor throughout the development and review process.

Other FDA news items of interest can be found here.

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