French ultrasound therapy technology developer CarThera said a phase I/IIA trial of its SonoCloud-1 ultrasound implant showed promising results for improving the treatment of recurrent glioblastoma multiforme (GBM).
The research, which was published online on 19 March in Clinical Cancer Research, showed that SonoCloud-1's ability to provide ultrasound-induced opening of the blood-brain barrier (BBB) offered a good safety profile and encouraging performance for improving the efficiency of carboplatin chemotherapy. In the study, 19 patients with recurrent GBM received up to 10 monthly ultrasound sonications. The clinical trial was performed at the AP-HP Pitié-Salpêtrière Hospital in Paris, and it was led by neurooncologist and principal investigator Dr. Ahmed Idbaih along with neurosurgeon and CarThera founder Dr. Alexander Carpentier.
The researchers found that 11 GBM patients treated with optimal pressure levels who had MRI-detected disrupted BBB had median progression-free survival of 4.11 months and median overall survival of 12.94 months. In comparison, the eight GBM patients without BBB disruption had median progression-free survival of 2.73 months and median overall survival of 8.64 months, according to CarThera.
The company said it's now recruiting recurrent GBM patients for a new clinical trial involving its next-generation SonoCloud-9 implantable ultrasound device, which is designed to cover a larger volume. SonoCloud-9 can cover the tumor, as well as the surrounding infiltrative regions, according to CarThera.
