5-ALA with CV01 / Alpheus Medical - LARVOL DELTA

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Alpheus Medical, Inc. | Active, not recruiting ➔ Completed

Trial completion • Brain Cancer • Glioma • High Grade Glioma • Oligodendroglioma • Oncology • Solid Tumor

Alpheus Medical Announces Positive Phase 1/2 Trial Results for the Treatment of Recurrent High-Grade Gliomas (PRNewswire) - P1/2 | N=22 | NCT05362409 | Sponsor; Alpheus Medical, Inc. | "Key findings from the study include: Median overall survival (OS): 15.7 months vs. historical ~6-8 months; Median progression-free survival (PFS): 5.5 months vs. historical 1.8 month; Safety: No treatment-related deaths, serious adverse events (SAEs), or duration-limited toxicities (DuLTs) reported....The company plans to initiate a randomized, controlled trial at multiple centers across the U.S. in 2025."

New trial • P1/2 data • Brain Cancer • Glioma • Oncology

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Alpheus Medical, Inc. | Recruiting ➔ Active, not recruiting | N=48 ➔ 22 | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Oligodendroglioma • Oncology • Solid Tumor

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Alpheus Medical, Inc. | N=33 ➔ 48 | Trial completion date: Apr 2024 ➔ Dec 2024 | Trial primary completion date: Apr 2023 ➔ Dec 2023

Enrollment change • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioma • Oligodendroglioma • Oncology • Solid Tumor

Alpheus Medical Treats First Patients in First-In-Human Clinical Trial for Novel High-Grade Glioma Brain Cancer Treatment (PRNewswire) - "Alpheus™ Medical Inc...today announced the treatment of the first three patients in the U.S.-based multi-center Phase 1 clinical trial evaluating the safety and optimal dosage of the company's proprietary platform....The FIH Phase 1 multi-center trial (NCT05362409) is designed to study the safety and optimal dosage of Alpheus' SDT treatment and is planned to enroll up to 33 patients."

Trial status • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Alpheus Medical, Inc. | Trial completion date: Sep 2023 ➔ Apr 2024

Trial completion date • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor

FDA Grants Alpheus Medical Orphan Drug and Fast Track Designations for Novel Sonodynamic Therapy for Brain Cancer (PRNewswire) - "Alpheus™ Medical, Inc...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 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."

Fast track designation • Orphan drug • Trial status • Brain Cancer • Glioblastoma • Glioma • Oncology

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma (clinicaltrials.gov) - P1 | N=33 | Recruiting | Sponsor: Alpheus Medical, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor

Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma (clinicaltrials.gov) - P1 | N=33 | Not yet recruiting | Sponsor: Alpheus Medical, Inc.

New P1 trial • Brain Cancer • Glioma • Oligodendroglioma • Oncology • Solid Tumor