CarThera, a French ultrasound company, has announced the start of a new clinical trial in France. The “SoniMel” study has enrolled and treated its first patient diagnosed with brain metastases from a primary melanoma.
This is CarThera’s third clinical trial using the SonoCloud device to deliver therapeutics to the brain, the first to assess delivery of an immunotherapy. Beyond demonstrating safety, the study is designed to determine optimal treatment dose.
This trial will assess the use of ultrasound-induced blood-brain barrier (BBB) opening to increase penetration of systemically delivered immunotherapies as well as natural endogenous immune cells into the brain. Up to 21 patients will receive checkpoint inhibitors (anti-PD1 alone or anti-PD1 plus anti-CTLA4) immediately before the implanted SonoCloud device is used to open the BBB.
“Enormous progress has been made in treating melanoma with new therapies, but despite progress in the treatment of brain metastases, therapeutic challenges are still high. In this respect, the SoniMel protocol is extremely important because of its technological innovation in opening the blood-brain barrier,” said Professor Céleste Lebbé, principal investigator at Saint Louis Hospital, Paris.
The hope is to eventually manage metastatic brain cancer as a chronic disease rather than with end-of-life care. “This study is of great interest for CarThera, as it targets a high unmet medical need, that of secondary tumors,” said Frederic Sottilini, CEO at CarThera. “The incidence of resistant brain metastases is significant in patients with melanoma, lung, or breast cancer.”
“Opening the blood-brain barrier with the SonoCloud system in patients treated with immunotherapies for brain metastases is an interesting avenue to explore in improving the brain’s immunological response,” said Pr. Alexandre Carpentier, head neurosurgeon at Sorbonne University and founder of CarThera.
The SoniMel study is sponsored by Assistance Publique Hopitaux de Paris and funded by the French Minister of Health.