Carthera announced today that it enrolled the first patient in the SONOBIRD pivotal trial for its SonoCloud device.
Paris, France-based Carthera designed SonoCloud to treat a wide range of brain disorders. The device emits ultrasound to temporarily increase the permeability of blood vessels in the brain, improving therapeutic molecule delivery.
After implantation in the skull, SonoCloud activates prior to the injection of a therapeutic agent. Several minutes of low-intensity ultrasound opens the blood-brain barrier (BBB) for six hours, increasing the concentration of therapeutic molecules in the brain.
SONOBIRD plans to treat recurrent glioblastoma (rGBM) in 560 patients across 40 sites in the U.S. and Europe. Dr. Johnny Duerinck (Universitair Ziekenhuis Brussel, Belgium) enrolled two patients in January. This marked the start of a two-year recruitment period for patients in the EU and U.S. Eligibility criteria include adult patients who have a first recurrence of disease and eligibility for a new tumor resection.
“We feel privileged to have enrolled the first patient in the SONOBIRD clinical trial,” Duerinck said in a news release. “The development of effective treatments against glioblastoma is limited, due to the BBB preventing most systemic drugs from reaching the brain parenchyma. By utilizing Carthera’s SonoCloud-9 device to temporarily open the BBB in the areas surrounding the tumor, we will be able to assess the effectiveness of carboplatin against existing treatments, with the aim of providing glioblastoma patients with better therapeutic options.”
The open-label, comparative, randomized trial evaluates overall survival in patients undergoing carboplatin chemotherapy. Patients receive treatment with SonoCloud-9 opening the BBB. The study compares outcomes to those from medical-consensus-recommended regimens (lomustine or temozolomide). It also evaluates SonoCloud-9’s effectiveness and carboplatin treatment in delaying or slowing tumor growth.
“We are proud to announce the enrollment of the first patient in our pivotal trial. This demonstrates our leadership in the development of therapeutic ultrasound for the treatment of neurological diseases,” said Frederic Sottilini, CEO of Carthera.