- Results from a US clinical trial using the SonoCloud-9® device for the treatment of recurrent glioblastomas were published in The Lancet Oncology.
- Investigators implanted the device in 17 participants then used it to repeatedly open the blood-brain barrier and deliver chemotherapy.
- The method was safe, well tolerated, and delivered up to a six-fold increase in chemotherapy concentration.
The results from Northwestern University’s phase I clinical trial of its SonoCloud-9® device (NCT04528680) have now been published in The Lancet Oncology. The study was led by Adam Sonabend, MD, and Roger Stupp, MD, at Northwestern University Feinberg School of Medicine in Chicago. The investigators implanted the SonoCloud device in 17 participants with recurrent glioblastoma then used it to repeatedly open the blood-brain barrier (BBB) and deliver chemotherapy (albumen-bound paclitaxel) to the peri-tumoral region. Each participant received up to six cycles of chemotherapy and activation of the ultrasound device.
In a subset of participants, the research team quantified the amount of chemotherapy that crossed the BBB to reach the peri-tumoral areas of the brain and found that the treatment increased drug concentrations by four- to six-fold. Using fluorescein, the surgeons mapped and visualized BBB opening during surgery. The SonoCloud-9 device can open the BBB over a large region of the brain adjacent to the tumor cavity.
In the Carthera press release, Dr. Sonabend said, “This is potentially a huge advance for glioblastoma patients. Temozolomide, the current chemotherapy used for glioblastoma, does cross the blood-brain barrier, but is a weak drug. In the past, studies that injected paclitaxel or carboplatin directly into the brain of patients with these tumors observed promising signs of efficacy, but the direct injection was associated with toxicity. In our study, the use of the SonoCloud-9 system has demonstrated promise for safe and tolerable delivery to patients.”
Participants in this trial first underwent brain surgery for resection of the recurrent tumor. When the surgeons closed the skull, they implanted the SonoCloud-9 system in place of the bone flap. Every three weeks, beginning a few weeks after surgery, participants returned to the clinic to undergo the BBB opening procedure and receive the paclitaxel chemotherapy regimen.
“The findings from this study provide further evidence that our next generation SonoCloud-9 technology can be used to safely disrupt the BBB over a large volume and significantly enhance the levels of a wide range of therapeutics in the human brain,” said Michael Canney, Chief Scientific Officer at Carthera.
Another Phase 1/2 Carthera study for participants with recurrent glioblastoma (NCT03744026), which delivered carboplatin, was also successful in increasing chemotherapy delivery to the brain tumor region. Carthera plans to initiate a phase 3 pivotal clinical trial for recurrent GBM in 2023. That study will evaluate whether the treatment can prolong survival as compared with standard of care.