A clinical trial for a revolutionary device to deliver cancer treatment

Glioblastoma, the most common form of malignant primary brain tumour in adults, is an incurable disease with a poor prognosis and an average survival rate of about 15 months under current therapies. One of the major obstacles to treatment is the blood brain barrier. Part of our body’s natural defence system, the blood brain barrier keeps disease-causing pathogens from passing into brain tissue, but it also blocks medicines that doctors want to introduce into our brains.

A new technology called SonoCloud uses low ultrasonic energy to stimulate microbubbles that stretch capillary walls and create a temporary opening in the brain blood barrier. A first-in-human trial of the technology has shown that it can be used to give a chemotherapy drug to glioblastoma patients, and that it appeared to improve the effectiveness of treatment.

With EIT Health Funding, the SonoFIRST project will conduct the first European clinical trial of the technology, making it possible for Europe to become the initial market to benefit from this revolutionary treatment.

Confirming a breakthrough

During this phase-2 clinical trial run by SonoFIRST, 60 European patients who have been newly diagnosed with glioblastoma will undergo the treatment, and their survival rate will be evaluated. The patients will have the SonoCloud device implanted, and it will be used to enhance the regular delivery of their medication. The trial in Europe will last for three years.

The clinical trial is intended to confirm a major breakthrough in the treatment of brain diseases. It could also allow for the revival or repurposing of drugs that have been abandoned in the absence of efficient delivery into the brain. This approach opens up the spectrum of agents that can be used against brain tumors and other severe brain diseases. Millions of patients with brain diseases could potentially benefit.

Facilitating development in Europe

EIT Health support includes expertise and funding to enable the clinical trial, with a launch in September in Pitié-Salpêtrière Hospital, part of Assistance Publique Hôpitaux de Paris, an EIT Health member.

By opening the product to development in Europe, the trial means that CarThera SA, the company behind SonoCloud, can continue its development and manufacturing in Europe, and make its product available to Europeans. This would be in keeping with the EIT Health goal of improving healthcare for the European patient. As an improvement in treatment, the project is also in line with the EIT Health Focus Area of Reforming Care Pathways.