CarThera Receives FDA Approval for Phase 1/2a Trial in Glioblastoma

CarThera, a French company that designs and develops innovative ultrasound-based medical devices to treat brain disorders, has announced that the FDA has granted approval to launch a Phase 1/2a clinical trial in the U.S. with its SonoCloud-9 ultrasound device in recurrent glioblastoma (GBM) patients treated with carboplatin.
 
CarThera’s low-intensity pulsed ultrasound device, the SonoCloud, is designed to temporarily open the blood-brain barrier (BBB), potentially improving the penetration of therapeutic agents into the brain to increase efficacy. The company recently reported the results of a Phase 1/2a glioblastoma trial in France (Pitie Salpetriere Hospital at AP-HP) with its first generation device, the SonoCloud-1.
 
Its next-generation device, the SonoCloud-9, brings a nine-fold increase in coverage of the tumor and surrounding infiltrative areas. A phase 1/2a clinical trial aiming at measuring the  safety, tolerance, and efficacy of repeated openings of the BBB by SonoCloud-9, before infusion of carboplatin in 27 patients, has already started in France (Paris and Lyon) and will soon be up and running at the MD Anderson Cancer Center in Houston and at the Northwestern Memorial Hospital in Chicago.
 
“We are excited to initiate this clinical trial in the U.S. to evaluate the potential of the SonoCloud-9 device for glioblastoma patients,” said Dr. Alexandre Carpentier, inventor of the technology and founder of CarThera. “Our first clinical study confirmed the safety and feasibility of this solution. We believe it represents a major step forward in the treatment of GBM.”
 
This phase 1/2a study in France, conducted by Dr. Ahmed Idbaih, is a preliminary step in the development of the SonoCloud-9 for glioblastoma. A pivotal trial should start at the end of next year in Europe and in the U.S. This should lead to marketing approvals in these regions.
 
“We are delighted with the FDA approval of our SonoCloud-9 study in GBM patients and are looking forward to expanding our activities in the U.S.,” said Frederic Sottilini, CEO of CarThera. “The appointment last month of Pascal E. R. Girin as our U.S.-based chairman of the board, our new subsidiary in Boston, and a number of translational research programs with renowned U.S. research institutes show our commitment to bringing our innovative technology to U.S. patients with brain tumors.”
 
According to the company’s estimates, each year 250,000 patients worldwide are diagnosed with a brain tumor. Each year about 3 in 100,000 people develop glioblastoma. It is the second most common central nervous system cancer after meningioma. In the U.S., the National Cancer Institute estimates that over 23,000 adults will be diagnosed in the United States with brain and nervous system cancer in 2019. 
 
The SonoCloud is the only tool capable of easily and repeatedly opening the BBB to allow for enhanced concentrations of therapeutics into the brain.
 
“Therapeutic ultrasound research has significantly increased in importance over the last decade. We are delighted that we can now introduce our ultrasound technology to U.S. clinical and research centers. We believe that this is a significant step in developing this technology for use with a wide range of therapies for treatment of brain diseases,” said Michael Canney, scientific director at CarThera.