Latest News from CarThera
CarThera announces the launch of a new phase I/II clinical trial (NCT04528680) in collaboration with Northwestern University in Chicago. The trial will recruit up to 39 patients with recurrent glioblastoma (GBM) to test the SonoCloud-9 device in combination with Abraxane® – an albumin-bound formulation of paclitaxel. The first patient in this trial has been treated and further patient recruitment is now on-going. The goal of the trial is to determine the safe dose of Abraxane to be used in combination with the SonoCloud-9 device in recurrent GBM patients (Phase I); then expand with the established safe dose in order to evaluate preliminary efficacy (Phase II).
CarThera announces that it has been selected by the EIC Accelerator Pilot to receive a €2 million ($2.3M) grant and €10.5M ($12M) in equity for the development of its DOMEUS project for the treatment of glioblastoma (GBM) patients. The company will also receive business coaching and mentoring to accompany its growth. With the DOMEUS project, CarThera will be able to scale-up its processes and organizational structure to bring its technology to an increasing number of patients around the world.
CarThera announces that the first patient has been enrolled and treated in a clinical trial evaluating the safety of using its SonoCloud® technology in combination with checkpoint inhibitors for the treatment of brain metastases from melanoma (NCT04021420). In this trial, anti-PD1 alone or in combination with anti-CTLA4 are administered in patients before SonoCloud-mediated Blood Brain Barrier opening (BBB). BBB opening can help boost the brain’s immunity and increase brain penetration of newly approved systemically delivered immunotherapies, such as checkpoint inhibitors. This could translate into controlling brain disease with the same magnitude as peripheral diseases, improving clinical outcomes for many patients worldwide.
CarThera will partner with Lantheus for the supply of microbubbles. Lantheus Holdings, Inc., parent company of Lantheus Medical Imaging, Inc., is a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. Lantheus’ microbubbles will become an integrated component of the SonoCloud product. This agreement strengthens the configuration of the SonoCloud system and secures the supply of the microbubbles for the coming years.
Under the terms of the clinical collaboration, KIYATEC will conduct ex vivo drug response profiling on glioblastoma tissue samples from patients enrolled in CarThera’s clinical study. CarThera will benefit from having ex vivo drug response profiling for patients enrolled in its study, while KIYATEC will correlate its patient-specific, pre-treatment drug response predictions with actual clinical outcomes of patients in CarThera’s study. For both companies, this collaboration represents an opportunity to enrich their portfolios of clinical evidence with the goal of helping clinicians improve outcomes for their patients with glioblastoma.
The company recently reported the results of a Phase 1/2a glioblastoma trial in France (Sorbonne University-Pitie Salpetriere Hospital at AP-HP) with its first generation device, the SonoCloud-1. At SNO, on Saturday, November 23, Professor Alexandre Carpentier will provide an update on the ongoing SonoCloud-9 trial. Before that, on Thursday, November 21, he will also present an invited talk on ‘Ultrasound Enabled Drug Delivery’ at a special 2-day joint SNO-SCIDOT (Society for CNS Interstitial Delivery of Therapeutics) session prior to the conference.
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.
Pascal Girin brings wealth of experience in medical device and life sciences industries to support CarThera’s future growth. Girin has decades of business expertise in the life sciences and medical devices markets, most recently as CEO of Balt, a leader in the treatment of neurovascular diseases. Prior to this, he held numerous C-level positions at leading medical companies, including Wright Medical, Keystone Dental (a Warburg Pincus company), EV3, Baxter and Ohmeda, among others. As chairman of CarThera’s board of directors, he will bring invaluable insight to the company’s business strategy and future development.
Final results of the phase I/IIa clinical trial (NCT02253212) on the ultrasound-induced blood-brain barrier (BBB) opening improving the efficiency of carboplatin chemotherapy for recurrent glioblastoma patients were published in AACR’s Clinical Cancer Research journal of the . Study results show a good safety profile and encouraging efficacy. These results are based on 65 sonication sessions with escalating ultrasound pressure levels. GBM patients treated with optimal pressure levels and MRI-detected disrupted BBB (11 patients) showed a median progression-free survival (PFS) of 4.11 months and a median overall survival (OS) of 12.94 months. This compares to 2.73 months and 8.64 months respectively, for GBM patients without BBB disruption (8 patients).
The SonoCloud-9 (NCT 03744026) trial is an open-label, dose escalation study to evaluate the safety and efficacy of temporarily opening the blood-brain barrier (BBB) in patients with recurrent glioblastoma, who are eligible for carboplatin chemotherapy, by using the implantable SonoCloud-9 device to emit low-intensity pulsed ultrasound. The study will be followed by an extension phase.
€9M ($10.3M) was raised with three institutional investors, Panakès Partners, Sham Innovation Santé (advised by Turenne Capital) and Supernova Invest via its fund Supernova 2, as well as Group Arnault and historical investors. The proceeds will be used to further advance the SonoCloud technology and develop the clinical pipeline of the company. A multi-center study has already been launched in France and in the US to evaluate the SonoCloud-9 device, a new generation of implant with nine ultrasound emitters, in patients with recurrent glioblastoma. The company also has an on-going clinical study with the SonoCloud-1 device in patients with Alzheimer’s disease and one planned for patients with brain metastases.
Preliminary data from the first clinical trial of the company’s intracranial ultrasound implant, SonoCloud®, show a good safety profile and promising trends in overall survival.
Dr. Ahmed Idbaih, AP-HP principal investigator of the Phase 1/2a clinical trial (NCT02253212) presented a preliminary analysis of the data from 21 glioblastoma patients who received 65 SonoCloud® treatments. Overall Survival was increased from 8.5 to 12.9 months in patients who had SonoCloud®-induced BBB opening.
CarThera will participate to the BIO International Convention in Boston on June 4-7 to meet with global biotech and pharma leaders and showcase its SonoCloud device.
Should you want to meet us at BIO and hear more about SonoCloud – our ultrasound device, aimed at improving treatment efficiency by temporarily opening the Blood Brain Barrier – contact us at email@example.com and come to Booth 527 at the France Pavilion.
June 2017 – Dr. Ahmed Idbaih, AP-HP principal investigator of the Phase 1/2a clinical trial (NCT02253212) on ultrasound induced Blood-Brain Barrier opening revealed preliminary safety and efficacy data at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The clinical data from the trial involving 21 patients with recurrent glioblastoma, who have all been treated with SonoCloud® low-intensity pulsed ultrasound in a total of 65 sessions, have been shared with more than 30,000 oncology professionals from around the world.
October 12, 2016 – CarThera has received a grant of €5.7 million ($6.4m) for its DOME project. The funding was awarded under the call for proposals ‘Structuring R&D Projects for Competitiveness’ from France’s ‘Investments for the Future Program’, led by the General Investment Commission and run by Bpifrance.
The grant will finance our SonoCloud Phase 2b/3 study in glioblastoma that will involve around 200 patients at centers in Europe and the United States. It will also fund a number of exploratory studies, including one on Alzheimer’s disease, building on the findings from the Phase 1/2a study that paved the way for a broader array of clinical indications.