Key Points
- A new clinical trial will compare the use of Carthera’s SonoCloud-9 implantable ultrasound device plus chemotherapy to standard-of-care therapies in patients with glioblastoma.
- The study will enroll 560 participants at 40 sites throughout the US and Europe.
Carthera has announced that the first patients have been treated in a large pivotal trial investigating the use of the SonoCloud-9 device for the treatment of recurrent glioblastomas (GBMs).
Called the SONOBIRD trial, this study will compare the use of the device combined with the chemotherapy drug carboplatin to standard-of-care therapies in patients with a first recurrence of GBM.
SonoCloud-9, invented by neurosurgeon Professor Alexandre Carpentier, is unique in that it is an implantable device positioned during a regular tumor debulking/resection surgery. In this trial, participants in one cohort will receive carboplatin, and researchers will use the SonoCloud-9 device to open the blood-brain barrier (BBB) to enable higher concentrations of the chemotherapy to enter the tumor tissue.
The second cohort will receive the standard-of-care therapies lomustine or temozolomide without BBB opening.
The open-label, comparative, randomized, multicenter, two-arm clinical trial with a 1:1 ratio will assess participants’ overall survival up to 24 months as well as tumor growth rate and tolerability of the procedure.
The first two patients were treated in Belgium in January, and in all, the trial will enroll 560 patients at multiple sites in the US and Europe over the next two years.
“The launch of the SONOBIRD trial is a significant achievement in the clinical development of the SonoCloud-9 system. If the efficacy of carboplatin in combination with our device is proven, it will change the paradigm of how we treat glioblastoma,” said Carole Desseaux, chief clinical officer at Carthera.
This study builds upon data from a previous Phase 1/2 study testing a similar protocol of SonoCloud-9 plus carboplatin for participants with recurrent glioblastoma (NCT03744026). The data from that trial are expected to be published in the coming months.