Wednesday, August 10, 2022

561.316.3330

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

Latest Posts

New Study Highlights Superior Efficacy of At-home Dry EEG assessment Compared to Lab-based Monitoring

Results indicate that easy-to-use task-driven EEG can yield clinical-grade data in large-scale, real-world investigations in neuroscience with extremely high adherence rates.

Gamida Cell Announces Dosing of First Patient in Company-Sponsored Phase 1/2 Study of NK Cell Therapy Candidate GDA-201

“We are excited to further advance the development of GDA-201, a NAM-enabled natural killer (NK) cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma,” said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell.

Akadeum Life Sciences Announces New Dead Cell Removal Kit Using Microbubble Technology

Akadeum Life Sciences advises that the new buoyant separation method creates a more effective way for researchers to use valuable samples with a higher retention rate of viable cells than current magnetic techniques.

Bio-Rad Extends Range of StarBright Violet and UltraViolet Dyes for Multiplex Flow Cytometry

StarBright Violet 760, StarBright UltraViolet 575, and StarBright UltraViolet 605 dyes conjugated to highly validated antibodies for multicolor panel design in immunology research.

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.

Latest Posts

Learn More

spot_img

Subscribe

spot_img

Our Sister Publication

Medical Device News Magazine