Blog

Novel Breast Cancer Treatment Approaches Using Therapeutic Ultrasound, Immunotherapy, and Chemotherapy

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Key Points A new article provides an overview of the global state of the field for using focused ultrasound to treat breast cancer. The authors outlined ongoing research using several mechanisms of action and five devices and highlighted the technology’s ability to engage the immune system. Focused ultrasound has the potential to become an alternative or complement to existing treatments in the management of breast cancer. Combination of Focused Ultrasound, Immunotherapy, and Chemotherapy: New Perspectives in Breast Cancer Therapy A recently published article provides an overview of the worldwide state of the field for using focused ultrasound to treat breast cancer and breast cancer metastases. Researchers from LabTAU (a Focused Ultrasound Center of Excellence) and the Focused Ultrasound Foundation outlined ongoing research using several different focused ultrasound mechanisms of action and five devices. Data from the review, as collected through July 2022, included the following findings: There are nine ongoing clinical trials using focused ultrasound to treat various types and stages of breast cancer. Seven preclinical and three clinical studies have investigated the use of focused ultrasound for immunomodulation of breast cancers.  The focused ultrasound devices that are currently being used to treat breast cancer are made by Chongqing HAIFU, Theraclion, Profound Medical, the University of Utah (MUSE), and Insightec. Chongqing HAIFU’s Model-JC breast cancer device is being used for thermal ablation. Theraclion’s Echopulse device is being used to ablate breast tumors before the delivery of a cancer immunotherapy and chemotherapy. Profound’s Sonalleve device is providing thermal ablation before breast cancer surgery in one study and combining focused ultrasound with chemotherapy in another. The University of Utah’s MUSE focused ultrasound ablation device is being tested for the treatment of breast tumors with thermal ablation. The Insightec focused ultrasound device uses focused ultrasound to activate microbubbles and open the blood-brain barrier to deliver chemotherapy to breast cancer brain metastases as well as activate microbubbles for radiation sensitization. Sonopermeation is another mode of action of therapeutic ultrasound. It relies on the ultrasound activation of microbubbles to enhance the delivery of chemotherapy, and it can be performed using a clinically approved ultrasound imaging device. Focused ultrasound has already been approved in some European and Asian countries for the treatment of breast cancer using thermal ablation. Another condition, benign breast tumors, has been approved to be treated with focused ultrasound in Taiwan, Korea, Singapore, Hong Kong, and Europe. Focused ultrasound has the potential to become an alternative or complement to existing treatments in the management of breast cancer, with ongoing research evaluating the potential to improve treatment outcomes and decrease side effects. The technology may help address the need to develop noninvasive, personalized, and effective breast cancer treatments that have fewer side effects. Although many advances have been made in its treatment, breast cancer is still the most prevalent cancer in the world according to the World Health Organization. See Journal of Ultrasound in Medicine
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Neuroimaging and Fluid Biomarker Data from Sunnybrook’s Ongoing Alzheimer’s Study Published

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Key Points Researchers recently published new data from an ongoing Alzheimer’s disease clinical trial using focused ultrasound to disrupt the blood-brain barrier (BBB). The data show that BBB disruption is safe across multiple areas of the brain and at expanded volumes. Although the treatment reduced the amyloid deposits in the brain, no improvement of the Alzheimer’s decline was observed. Blood-Brain Barrier Opening of the Default Mode Network in Alzheimer’s Disease with Magnetic Resonance–Guided Focused Ultrasound A collaborative group of international researchers based at Sunnybrook Research Institute recently published neuroimaging and fluid biomarker data from Sunnybrook’s ongoing study using MR-guided focused ultrasound (MRgFUS) to disrupt the blood-brain barrier (BBB) in participants with Alzheimer’s disease (AD). The team has been seeking to expand the reach of the technique throughout the various regions of the brain (including the regions controlling memory) and to increase the volume and number of BBB disruptions in each area. This update on the first nine patients enrolled in an ongoing clinical trial (NCT03739905) shows that this type of expansion for BBB disruption is safe. These safety data are crucial, especially to the broader medical community, because the BBB is an important physiologic structure, and even temporary disruption of it needs to be shown to be without adverse events. Furthermore, MRgFUS did reduce the amyloid deposits in the brain, although no amelioration of the AD decline was observed. “Our results show that we can now continue expanding the parameters for our trial, both clinically and technically,” said Nir Lipsman, MD, PhD, the study’s principal investigator and director of Sunnybrook’s Harquail Centre for Neuromodulation. “We hope to comprehensively measure key outcomes, including amyloid and tau levels before and after each treatment and, critically, to enhance the delivery of promising therapeutics across the BBB.” The discussion of the manuscript also notes: “These results set the stage for larger trials pairing MRgFUS with promising AD therapeutics for which the BBB is an important obstacle. Intravenous immunoglobulin, for example, may be a promising and ready candidate as it has been shown to synergistically promote neurogenesis and modulate the inflammatory milieu with [focused ultrasound] in animal models.” See Brain >
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Blog: Gene Therapy and Rare Disease

Written by Bob Smith
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Bob Smith is an accomplished biopharmaceutical executive with over 30 years of experience. He leads Pfizer’s Gene Therapy and Rare Disease portfolio. This blog has been adapted from Mr. Smith’s recorded presentation for the 2022 Symposium.
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Bob Smith

Focused Ultrasound Treatment Comparable to Radiation Therapy for Patients with Painful Bone Metastases

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Key Points Prof. Alessandro Napoli and his team at Sapienza University of Rome conducted a comparative phase II clinical trial that enrolled 198 participants with painful bone metastases. When compared with external beam radiation therapy (EBRT), focused ultrasound produced a faster and better pain control response that lasted longer than EBRT. An accompanying editorial praised focused ultrasound as a promising new advance in interventional oncology and suggested that future comparative trials follow this study model as a practical approach to adopting innovative new treatments. Focused Ultrasound and External Beam Radiation Therapy for Painful Bone Metastases: A Phase II Clinical Trial Prof. Alessandro Napoli and his team at Sapienza University of Rome conducted a comparative, nonrandomized, phase II clinical trial that enrolled 198 participants with painful bone metastases. The study compared the safety and effectiveness of treating the bone metastases with focused ultrasound or EBRT. Beyond numeric pain rating scales at 1- and 12-months following treatment, the open-label protocol also included assessment of quality-of-life measures and analysis of adverse events. Focused ultrasound had statistically significant higher overall response rates than EBRT at both 1- and 12-months post procedure and statistically significant lower overall adverse event rates. The authors concluded that focused ultrasound was comparable to EBRT for improving pain palliation and quality of life. In an accompanying editorial, “Radiation Therapy Castle Under Siege: Will It Hold or Fold?” Alexis Kelekis, MD, PhD, EBIR, FSIR, FCIRSE, said that focused ultrasound was among several new advances in interventional oncology for providing local energy deposition. He noted some of the current disadvantages of focused ultrasound (e.g., it is a long and tiring single-session treatment that requires anesthesia) but said that the technology’s absence of ionizing radiation and better overall results than EBRT for treating bone metastases make it “a promising alternative for the future.” After describing that the partial response rate in the study favored EBRT, Dr. Kelekis added, “Perhaps the future lies in combined therapies and hybrid techniques trying to bridge and exploit the advantages of each therapeutic approach.” He went on the praise the study design and suggested that the model should be adopted by more researchers to increase the use of innovative and novel therapies that provide real hope to patients. Suzanne LeBlang, MD, the Foundation’s Director of Clinical Relationships, has known Dr. Napoli for nearly 16 years. She says, “Dr. Napoli was one of the early pioneers in the field, and this important paper adds to the mounting body of knowledge about the benefits of focused ultrasound. Moving forward, we are hopeful that others will perform seminal research projects and publish findings for other indications because focused ultrasound is a platform technology that has widespread applicability to other diseases.” See Radiology > See Dr. Kelekis’ Editorial > See Media Coverage of the Study: Medpage Today
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Focused Ultrasound Now FDA Approved to Treat Essential Tremor Patients’ Second Side Meeting Report: American Epilepsy Society (AES) 2022 Meeting Report: 183rd Meeting of Acoustical Society of America (ASA) 2022 Meeting Report: Congress of Neurological Surgeons (CNS) 2022 Meeting Report: Radiological Society of North America (RSNA) 2022