Brain cancer implantable device trial
29 June 2023
Carthera will implant a device in patients with brain cancer to help the passage of chemotherapy drugs into brain tissue by opening the blood-brain barrier, after the company secured €37.5m ($41m) to fund a late-stage trial.
An unnamed investor led the Series B round, with participation from the European Innovation Council Fund and existing investors. Paris-based Carthera will be evaluating its ultrasound technology – called SonoCloud in patients with recurrent glioblastoma.
“The technology is low-intensity pulsed ultrasound (LIPUS), which is used to temporarily open the blood-brain barrier – the natural barrier in the brain that prevents therapeutics molecules from penetrating in sufficient concentration to the brain tissue,” Carthera CEO Frédéric Sottilini told Medical Device Network.
Carthera’s LIPUS device, which received breakthrough device designation from the US Food and Drug Administration (FDA) in mid-2022, is implanted after standard glioblastoma surgery and is neither visible nor able to be felt by the patient. It is activated prior to an injection of a therapeutic agent, opening the blood-brain barrier for six hours to help molecules seep into brain tissue.
The company said it is currently submitting its registration for the Phase III trial to the FDA and EU regulatory authorities. The study is planned to be an open-label, international, multicentre, two-arm clinical trial randomised with a 1:1 ratio and will evaluate the overall survival of patients with recurrent glioblastoma when treated with its SonoCloud-9 system after carboplatin chemotherapy administration. Patients will be compared to those who receive the chemotherapy drugs lomustine and temozolomide – the current standard of care.
Carthera has already conducted clinical trials with the technology. Results from a Phase I trial were published in The Lancet Oncology, and a Phase II trial demonstrated positive efficacy data. In a statement announcing the funding, Professor Alexandre Carpentier – inventor of the SonoCloud and founder of Carthera – said that the SonoCloud system has treated more than 100 patients across Europe and the US, with almost 500 procedures performed.
Using ultrasound to temporarily open the blood-brain barrier isn’t completely new and its use is well documented in treating neurodegenerative conditions. Sottilini told Medical Device Network that what sets Carthera’s technology apart from methods currently in use is the implantable nature of the device.
“Other companies are trying to get ultrasound through the skull using focused ultrasound. A major drawback is that the ultrasound has to cross the skull, with 95% of the energy reflected or diffracted. You need to use MRI monitoring, and that means the procedure can be very long – taking three to four hours.”
“A major advantage of our technology is that it can be activated on demand, it only takes two to four minutes for us to open the blood-brain-barrier at a large volume encompassing the tumour and the surrounding tissue.”
Sottilini added that although glioblastoma was chosen first because of the significant clinical unmet need, the company is also targeting other indications such as Alzheimer’s disease.
The device is not yet FDA-approved, but Sottilini said that the company is targeting market approval in the next few years.
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Also published on: Medicaldevice-network.com
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