French regulators approved a phase I-2 clinical trial of an ultrasound device to treat recurrent glioblastoma.
French-based CarThera is hopeful that its implantable SonoCloud-9 will help open up the blood-brain barrier in patients with recurrent glioblastoma who are eligible for carboplatin chemotherapy.
The device issues low-intensity pulsed ultrasound and it’s already proved safe and effective for patients in the short-term. The company has just won French approval for an open-label dose escalation study that will enroll 20 patients over the next year.
CarThera officials are hoping for FDA approval to extend the trials to the U.S., in the MD Anderson Cancer Center in Houston and Northwestern Memorial Hospital in Chicago.