Lantheus Enters into Strategic Collaboration with CarThera for Use of Microbubbles in Combination with SonoCloud® System for Treatment of Glioblastoma
Agreement Supports Lantheus’ Microbubble Franchise Growth Strategy and Expansion into Oncology
Under the commercial supply agreement, Lantheus’ microbubbles will be used as a component in CarThera’s SonoCloud® System, which uses low-intensity pulsed ultrasound (LIPU) specifically designed to open the blood-brain barrier to facilitate more effective delivery of chemotherapy to tumors. As part of the agreement, CarThera will be responsible for regulatory filings and approvals in the U.S.,
“We are excited to collaborate with CarThera to extend our microbubble franchise into the oncology field to target glioblastoma, an aggressive type of brain cancer with significant unmet medical need,” said
“We are delighted to enter into this collaboration with
CarThera’s SonoCloud-9 System is currently being evaluated in a Phase IIa clinical trial with a Phase IIb/III pivotal clinical trial to follow. The objective of this trial to evaluate the safety and efficacy of repeated opening of the blood brain barrier using the SonoCloud-9, its next-generation implantable ultrasound device designed to cover the entire tumor and surrounding infiltrative areas. Twenty-one patients will undergo repeated blood brain barrier opening with the SonoCloud-9 prior to infusion of carboplatin at clinical sites in
Roughly 12,000 people are diagnosed per year with glioblastoma in the U.S.2, and incidence is growing more than 1% per year3. Worldwide, annual incidence is as high as 5 in 100,000 people, and roughly 225,000 people die from the disease each year.4
The first line treatment for most glioblastoma patients is surgical resection of the tumor. After a healing period from surgery, patients will then typically undergo radiation and chemotherapy treatment cycles.5 The main goal of surgery is to remove as much GBM tumor as possible without impacting surrounding normal brain tissue that is critical for normal neurological function (such as motor skills, speaking and walking ability, etc.). However, GBMs are commonly surrounded by a reservoir of migrating, infiltrating tumor cells that invade surrounding tissue, making it virtually impossible to remove the cancer entirely. Surgery does help to reduce the amount of solid tumor tissue within the brain and thus can reduce intracranial pressure. The surgical debulking of tumor can prolong life and improve the quality of life for patients.5 The treatment of this region surrounding the tumor using chemotherapy is challenging due to the limited penetration of agents into the brain owing to the highly protective blood-brain barrier, a layer of specialized endothelial cells. Research has shown the blood-brain barrier can be accessed using ultrasound in combination with systemic injection of an ultrasonically resonated microbubble.
About the SonoCloud System
Earlier this year, CarThera published results from a Phase I/IIa clinical trial using SonoCloud-1 ultrasound implantable device to open the blood-brain barrier prior to carboplatin chemotherapy in patients with rGBM. Those results from 19 patients, published in the March 19, 2019 edition of journal Clinical Cancer Research, revealed a good safety profile and demonstrated the feasibility and promising potential of the SonoCloud® approach. Notably, the 11 rGBM patients who received optimal pressure levels of ultrasound showed a median progression-free survival (PFS) of 4.11 months and a median overall survival (OS) of 12.94 months as compared to those patients who received a suboptimal dosage, in whom median PFS and OS were 2.73 months and 8.64 months, respectively.6
CarThera designs and develops innovative therapeutic ultrasound-based medical devices for treating brain disorders. The company is a spin-off from AP-HP, Greater Paris University Hospitals, the largest hospital group in Europe, and Sorbonne University. Since 2010, CarThera has been leveraging the inventions of Professor Alexandre Carpentier, a neurosurgeon at AP-HP who has achieved worldwide recognition for his innovative developments in treating brain disorders. CarThera developed SonoCloud, an intracranial ultrasound implant that temporarily opens the blood-brain barrier (BBB).
CarThera is based at the Brain and Spine Institute (Institut du Cerveau et de la Moelle épinière, ICM) in Paris, France, and has laboratories at the Bioparc Laënnec business incubator in Lyon, France. The company, led by Frederic Sottilini (CEO), works closely with the Laboratory of Therapeutic Applications of Ultrasound (Laboratoire Thérapie et Applications Ultrasonores, LabTAU, INSERM) in Lyon. Since its inception, the company has received support from the AP-HP, Sorbonne University, the ANR (Nationale Research Agency), France’s Ministry of Research, the Ile-de-France region, the Bpifrance public investment bank, the Medicen Paris Region and Lyonbiopôle clusters. For more information, visit www.carthera.eu.
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1 Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura SJ, et al. Improved survival time trends of glioblastoma using the SEER 17 population-based registries. J Neuro Oncol. 2012;107(1):207–12.
4 Bush, N. A., Chang, S. M., and Berger, M. S. (2017). Current and future strategies for treatment of glioma. Neurosurg. Rev. 40, 1–14. doi: 10.1007/s10143-016-0709-8.
6 Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. Ahmed Idbaih, Michael Canney, Lisa Belin, Carole Desseaux, Alexandre Vignot, Guillaume Bouchoux, Nicolas Asquier, Bruno Law-Ye, Delphine Leclercq, Anne Bissery, Yann De Rycke, Clementine Trosch, Laurent Capelle, Marc Sanson, Khe Hoang-Xuan, Caroline Dehais, Caroline Houillier, Florence Laigle-Donadey, Bertrand Mathon, Arthur André, Cyril Lafon, Jean-Yves Chapelon, Jean-Yves Delattre and Alexandre Carpentier. Clinical Cancer Research: March 19, 2019
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