Carthera Receives Positive Opinion from French High Authority

Carthera, a spin-off from Sorbonne University and developer of SonoCloud, announced that HAS, the French High Authority for Health, has issued a positive opinion on taking over the costs associated with the SonoCloud-9 system in the SONOBIRD study, within the framework of the Forfait Innovation (Innovation Funding) program.

 

“We are delighted with this positive opinion from the HAS, which demonstrates real support in finding more effective treatments for glioblastoma patients in France. Following the Breakthrough Device Designation and Orphan Drug Designation from US and EU authorities for carboplatin when used with Carthera’s SonoCloud technology, this is another important step in our project to rapidly make BBB opening with SonoCloud available to patients with glioblastoma and offer new therapeutic options,” said Frédéric Sottilini, CEO of Carthera.

 

Carthera will receive funding from Forfait Innovation given the completion of a prospective study demonstrating the technology’s clinical potential. The acceptance into the innovation funding scheme will provide fast-track access to the market. 

 

Carthera plans to enter budget discussions with the French Ministry of Solidarity and Health. Upon completion, Forfait Innovation will finance the SonoCloud products used for the conduct of the SONOBIRD international comparative trial at the French study sites.

 

SONOBIRD is an open-label, comparative, randomized, multicenter, two-arm clinical trial with a 1:1 ratio that will evaluate overall survival in patients undergoing carboplatin chemotherapy and treated with the SonoCloud-9system to open the Blood-Brain Barrier (BBB). This will be compared to the medical consensus-recommended regimens (lomustine or temozolomide). The trial will also evaluate the effectiveness of SonoCloud-9 and carboplatin treatment in delaying or slowing tumor growth.

 

Carboplatin has been chosen for its proven anti-tumoral activity and has already been tested as a monotherapy in patients with glioblastoma. It shows limited Central Nervous System (CNS) toxicity at high doses or indirect exposure. However, it has limited penetration through the BBB when administered using standard intravenous (IV) routes. 

 

Brain concentrations of carboplatin can be significantly enhanced when coupled with the SonoCloud-9 system to temporarily disrupt the BBB. 

 

“The positive opinion from the French High Authority for Health on Forfait Innovation is a recognition of the significant innovation likely to be delivered to glioblastoma patients by the SonoCloud device,” said Professor Alexandre Carpentier, head of the neurosurgery department at AP-HP Sorbonne University, inventor of SonoCloud and founder of Carthera. “It also acknowledges that the proposed SONOBIRD study should be able to answer the primary endpoint question about the overall survival associated with administration of carboplatin chemotherapy after BBB opening using SonoCloud.”

 

Preliminary safety and efficacy results for combining SonoCloud-9 with carboplatin have been published in Nature Communications.