FRANCE –Carthera has announced the publication of findings from an investigator-sponsored pilot clinical trial evaluating the safety and efficacy of its Sonocloud technology in patients with mild Alzheimer’s disease.
These findings were published in Alzheimer’s Research and Therapy.
“The study’s findings complement the promising results already published and confirm the significant role that the Sonocloud device can play in the treatment of a wide spectrum of brain diseases, particularly if coupled with a novel drug therapy,” said Alexandre Carpentier (Assistance Publique Hôpitaux de Paris [AP-HP], Paris, France).
“Carthera is actively seeking collaborations with pharma partners to further develop this technique and allow a greater number of patients to benefit from this innovative treatment.”
According to Carthera, the use of low-intensity pulsed ultrasound (LIPU) has been shown in the last decade to temporarily disrupt the blood-brain barrier (BBB), reduce -amyloid and tau pathologies, and improve cognitive performance in Alzheimer’s preclinical models.
The company also claims in a press release that Sonocloud, an implantable 1MHz ultrasound device that can be activated on demand using a transdermal needle connected to an external interface, harnesses the therapeutic potential of this technique in an easy-to-use system that allows for repeated treatments in patients.
Carpentier and Stéphane Epelbaum conducted a translational study at Hôpitaux Universitaires Pitié Salpêtrière in Paris, France, following previous trials that demonstrated the potential of Sonocloud to safely enhance the delivery of chemotherapy to patients with brain tumors.
The purpose of this study was to show that this technique was safe in patients with mild Alzheimer’s disease and to see if ultrasound alone could reduce their amyloid load.
According to the release, a single-emitter version of the Sonocloud was implanted under local anesthesia in patients with mild Alzheimer’s to target the left supramarginal gyrus.
Over the course of three and a half months, nine patients were subjected to seven ultrasound sessions (each lasting about ten minutes) twice a month in order to temporarily disrupt the BBB.
PET imaging was used to monitor brain metabolism and amyloid levels at inclusion, as well as four and eight months after the initial sonications.
The AP-HP trial demonstrated that the Sonocloud can disrupt the BBB in Alzheimer’s patients and confirmed the safety previously demonstrated in patients with brain tumors in a study published in Clinical Cancer Research in 2019.
Despite the short treatment and observation window, a slight decrease in amyloid load was reported in the majority of patients, confirming the therapeutic potential of this modality, according to Carthera.
“We are currently planning a clinical trial that will lead to marketing authorization of the Sonocloud for the treatment of glioblastoma, while also continuing to explore this technology in a greater number of brain indications in combination with various therapeutic agents,” said Frédéric Sottilini, CEO of Carthera.
“The outcomes of this study reinforce our conviction that the Sonocloud has the potential to unlock the efficacy of therapies for brain diseases that were previously untreatable.”
Liked this article? Sign up to receive our regular email newsletters, focused on Africa and World’s healthcare industry, directly into your inbox. SUBSCRIBE HERE