CarThera Starts Phase I/II of Clinical Trial to Test for SonoCloud-9
pharmatechoutlook

Pharma Tech Outlook: Pharma Tech Magazine

CarThera Starts Phase I/II of Clinical Trial to Test for SonoCloud-9

By Pharma Tech Outlook | Tuesday, January 05, 2021

Frederic SOTTILINI, CEO

CarThera recently announced the start of a new Phase I/II clinical trial that will recruit 39 patients with recurrent glioblastoma (GBM) to assess the SonoCloud-9 system in conjunction with Abraxane.

FREMONT, CA: In partnership with Northwestern University in Chicago, CarThera, a French company that designs and develops groundbreaking ultrasound-based medical devices for the treatment of brain disorders, recently announced the start of a new Phase I/II clinical trial. Up to 39 patients with recurrent glioblastoma (GBM) will be recruited from the study to assess the SonoCloud-9 system in conjunction with Abraxane, an albumin-bound paclitaxel formulation. SonoCloud-9 is an implantable device with nine ultrasound emitters triggered to open the blood-brain barrier in combination with microbubbles temporarily. It helps drugs like Abraxane to penetrate the tissue of the brain. The first patient was treated in this trial, and further recruiting of patients is now underway.

The trial's purpose is to determine the safe dose of Abraxane that can be used in chronic GBM patients in conjunction with the SonoCloud-9 system (Phase I) and then extend the safe amount to assess preliminary efficacy (Phase II).

Supported by Northwestern University, this study is being funded as an R01 (Research Project Grant) by the US National Cancer Institute (NCI) / National Institutes of Health (NIH) and led by researchers Dr. Adam Sonabend, neurosurgeon, and Dr. Roger Stupp, neuro-oncologist. Dr. Sonabend will also conduct intraoperative portion studies to ensure that the drug reaches cytotoxic concentrations after sonications to disrupt the BBB, measure drug concentrations in patients' brain tissue.

"This is a remarkable time. We are delighted that we have been awarded an R01 grant to fund this clinical trial that will explore alternative drugs in combination with the SonoCloud device. Paclitaxel is potentially one of the most potent drugs against GBM, yet it's use in this indication has been limited because it does not cross the BBB," said Dr. Sonabend. "Over the last few years, we have explored new therapies in preclinical glioma models in partnership with CarThera; the data with Abraxane look promising."

"Now, we are pleased to be able to offer this innovative technology and treatment to patients with recurrent glioblastoma. We have already treated the first patient, a second patient will be treated later this month," added Dr. Stupp.

Weekly Brief

Read Also