Carthera has announced the enrolment of the first patient in the SONOBIRD pivotal trial assessing its ultrasound-based Sonocloud medical device for the treatment of recurrent glioblastoma (rGBM). The trial aims to treat 560 patients across 40 sites in Europe and the USA, with a view to ultimately securing marketing authorisation for the device.
Johnny Duerinck, in the department of Michaël Bruneau and in close collaboration with Bart Neyns (all University Hospital Brussels, Brussels, Belgium), enrolled two patients in January 2024, marking the start of a two-year recruitment period for patients in the EU and USA.
“We feel privileged to have enrolled the first patient in the SONOBIRD clinical trial,” said Duerinck. “The development of effective treatments against glioblastoma is limited, due to the BBB [blood-brain barrier] preventing most systemic drugs from reaching the brain parenchyma. By utilising Carthera’s Sonocloud-9 device to temporarily open the BBB in the areas surrounding the tumour, we will be able to assess the effectiveness of carboplatin against existing treatments, with the aim of providing glioblastoma patients with better therapeutic options.”
This open-label, comparative, randomised, multicentre, two-arm clinical trial with a 1:1 ratio will evaluate overall survival in patients undergoing carboplatin chemotherapy and treated with the Sonocloud-9 system to open the BBB. This will be compared to the medical consensus-recommended regimens—lomustine or temozolomide. The trial will also evaluate the effectiveness of the Sonocloud-9 and carboplatin treatment in delaying or slowing tumour growth. Eligibility criteria for the study include adult patients who have a first recurrence of their disease and who are eligible for a new tumour resection.
The SONOBIRD trial follows on from the SC9-GBM-01 trial—from which full results are expected to be published in Q2 2024—that demonstrated the feasibility and safety profile of the Sonocloud-9, as well as the potential of carboplatin tested as a monotherapy in combination with BBB opening.
“The launch of the SONOBIRD trial is a significant achievement in the clinical development of the Sonocloud-9 system,” said Carole Desseaux, chief clinical officer at Carthera. “If the efficacy of carboplatin in combination with our device is proven, it will change the paradigm of how we treat glioblastoma.”
