Carthera, which develops the Sonocloud—an ultrasound-based medical device used to treat a wide range of brain diseases—has announced today the completion of an end-of-Phase 2 meeting with the US Food and Drug Administration (FDA).
The company presented preclinical and clinical data from its Phase 1 and 2 trials, and met support from the FDA to progress into the Phase 3 step of a clinical programme evaluating the Sonocloud-9 system for the treatment of recurrent glioblastoma (rGBM).
This is another important milestone for the Sonocloud system, a Carthera press release details, with the device also being granted Breakthrough Device designation by the FDA in 2022.
The Sonocloud uses low-intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB) and deliver higher brain exposure to therapeutic compounds.
Carthera recently completed a Phase 1/2 trial in rGBM with carboplatin in 33 patients and a Phase 1 trial in rGBM with nab-paclitaxel in 17 patients. In total, over 60 patients have been treated to date with the Sonocloud-9 in glioblastoma trials across more than 250 treatment procedures.
“We had a very positive interaction with the FDA, and its responses will now enable our team to finalise the design and to initiate the pivotal trial,” said Sandra Thiollière, head of regulatory affairs at Carthera. “The company is planning the Phase 3 trial submission in Europe and the USA in the coming weeks.”