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CarThera obtains ANSM approval to launch its Phase I-II clinical trial for the SonoCloud-9 device in the treatment of recurrent glioblastoma

Paris, France, January 15, 2019 - CarThera, a French company that designs and develops innovative ultrasound-based medical devices to treat brain disorders, today announces it has secured approval from the French National Agency for Medicines and Health Products Safety (ANSM) to start a Phase I-II clinical trial of its SonoCloud-9 device in the treatment of recurrent glioblastoma.

 

The SonoCloud-9 (NCT 03744026) trial is an open-label, dose escalation study to evaluate the safety and efficacy of temporarily opening the blood-brain barrier (BBB) in patients with recurrent glioblastoma, who are eligible for carboplatin chemotherapy, by using the implantable SonoCloud-9 device to emit low-intensity pulsed ultrasound. The study will be followed by an extension phase. Twenty patients will be enrolled over a one-year period. The trial will take place in two hospitals in France, Pitié Salpêtrière in Paris and Pierre Wertheimer in Lyon. Following regulatory approval in the US, it will be extended to the MD Anderson Cancer Center in Houston and Northwestern Memorial Hospital in Chicago. Local, temporary opening of the BBB using short-duration, lowintensity pulsed ultrasound delivered in a controlled manner will make it easier for carboplatin to cross into the brain tissue, enabling better chemotherapy penetration of the tumor infiltration zone for greater efficacy.

 

 

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