Company’s Phase 2 clinical trial aims to find meaningful clinical endpoints regarding tumor regression and survival rates.
March 08, 2023 08:00 AM Eastern Standard Time OAKLAND, Calif.--(BUSINESS WIRE)--SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), today announced that the first cohort in SDT-202 was fully enrolled. SDT-202 is an open-label, dose-escalation trial of SDT in recurrent glioblastoma (rGBM). The objectives of SDT-202, which builds upon a previous proof-of-concept (POC) trial conducted by Nader Sanai, MD, Chief Scientific Officer and Director at the Ivy Brain Tumor Center at Barrow Neurological Institute, are to evaluate the safety, optimal dose, and efficacy of SDT.
“Our goal is to offer patients a good quality of life and make rGBM manageable, rather than lethal.”
Tweet this The first cohort in SDT-202 was enrolled at Cleveland Clinic by principal investigator Matthew Grabowski, MD.
“In the previous POC study, Dr. Sanai and his team demonstrated that SONALA-001 SDT was well tolerated and led to targeted oxidative stress and cell death in human high-grade glioma tissue without harming surrounding tissue,” said Dr. Mitchel Berger, MD, FAANS, who chairs SonALAsense’s Scientific Advisory Board. “Within four days after a single treatment, there was tumor cell death. The speed of action and repeatability of this unique therapy has the potential to be a game-changer for patients living with rGBM.”
At the start of the SDT procedure, a patient is given an injection of SONALA-001, an intravenous formulation of aminolevulinic acid (ALA). The drug is taken up selectively by cancer cells because they need ALA to make the heme molecule. Next, MR-guided ultrasound is used to focus ultrasound waves to create light in the brain through a process called sonoluminescence. The light activates a byproduct of SONALA-001 to create a “smart bomb” that is designed to trigger immediate and programmed cell death only in cancer cells.
“At SonALAsense, we are excited to further develop SONALA-001 SDT as a potential approach to treat this devastating brain cancer. Current options for rGBM, such as surgery, radiation, chemotherapy, and antibody drugs have significant side effects,” said Mark de Souza, PhD, Chief Executive Officer at SonALAsense. “Our goal is to offer patients a good quality of life and make rGBM manageable, rather than lethal.”
Dr. Grabowski at the Cleveland Clinic, along with other investigators at collaborating sites including the University of California San Francisco, Mayo Clinic, Ivy Brain Tumor Center, MD Anderson, NYU, and West Virginia plan to enroll approximately 50 participants in SDT-202. Patients interested in the trial can learn more at clinicaltrials.gov.
“Recurrent glioblastoma multiforme is a devastating brain cancer. We in the brain tumor community are eager for alternative treatments to prolong and improve our loved ones’ quality-of-life,” said Ralph DeVitto, President and Chief Executive Officer of the American Brain Tumor Association (ABTA). “We look forward to the outcomes of this clinical trial and learning more about the potential benefits of sonodynamic therapy.”
About SonALAsense
SonALAsense is a clinical-stage company developing sonodynamic therapy (SDT) as a first-in-class, noninvasive drug-device combination for the treatment of recurrent glioblastoma multiforme, diffuse intrinsic pontine gliomas, and other life-threatening cancers. SDT utilizes SONALA-001 (a drug) in combination with MR-guided focused ultrasound (a device) to selectively target and kill tumor cells. Follow SonALAsense on Twitter and LinkedIn and visit our website at sonalasense.com.
FAU AND INSIGHTEC PARTNER TO TREAT NEUROLOGICAL DISORDERS
FAU, Insightec, Neurological Diseases, Focused Ultrasound, Collaboration The collaboration will advance scientific knowledge about the use of focused ultrasound to treat brain diseases, including Parkinson’s disease and Alzheimer’s disease.
During his trade mission trip to Israel, Florida Gov. Ron DeSantis announced a new agreement between Florida Atlantic University and Insightec, a global health care company headquartered in Haifa, Israel. This agreement will enable FAU and Insightec to collaborate to advance scientific knowledge about the use of focused ultrasound to treat brain diseases, including Parkinson’s disease and Alzheimer’s disease.
By harnessing acoustic energy, Insightec’s innovative technology uses focused ultrasound to treat diseases in different ways. Currently, high intensity focused ultrasound (HIFU) is a United States Food and Drug Administration-approved means of creating lesions that treat Parkinson’s disease. More recently, the system has been used under different paradigms to non-invasively modulate and disrupt the blood-brain barrier, a network of blood vessels that plays a key role in keeping harmful substances from reaching the brain. At the same time, the blood-brain barrier also prevents the uptake of most pharmaceuticals, which makes it difficult to treat diseases of the brain. Alzheimer’s disease and other neurological diseases may be treated by opening the blood-brain barrier.
FAU and Insightec will explore opportunities to collaborate on research using focused ultrasound in pre-clinical settings both to non-invasively introduce therapeutic drugs across the blood-brain barrier to accelerate development of treatments for these neurological diseases and optimize HIFU and low intensity focused ultrasound to change the way the nervous system functions.
“Gov. DeSantis has set the stage to place neurological diseases such as Alzheimer’s disease at the forefront of health issues in the state of Florida and we appreciate his vision and continued support,” said Brad Levine, FAU Board of Trustees chair. “This important partnership between Florida Atlantic University and Insightec will help to propel novel therapies to meaningfully impact brain health and attain patient access to advanced care.”
As part of the agreement, FAU will leverage its clinical and academic expertise in the areas of preclinical research and basic sciences related to neurological conditions as well as its capacity and capabilities to conduct clinical research in these areas. Insightec will provide its expertise and resources related to research and development as well as its pre-clinical and clinical experience with the focused ultrasound platform.
“Improving the lives of patients is core to our mission at Insightec, and Florida Atlantic University shares our mission,” said Maurice R. Ferré, M.D., CEO and chair of the board of directors for Insightec. “There is a great urgency to accelerate the pace of medical innovation to treat neurological diseases. Together with our academic research partners at FAU we will advance preclinical and clinical investigations and further examine the potential of the therapeutic power of focused soundwaves.”
FAU has a vibrant neuroscience ecosystem including its state-of-the-art FAU Stiles-Nicholson Brain Institute located on the John D. MacArthur Campus in Jupiter, which serves as a collaborative hub for neuroscience and fosters connections to unravel the complex mysteries of the brain to ultimately improve quality of life.
Julie Pilitsis, M.D., Ph.D., dean and vice president for medical affairs in FAU’s Schmidt College of Medicine, will lead FAU’s clinical research efforts. She has had National Institutes of Health funding on focused ultrasound for the past 10 years and is considered a leading expert in the arena. She is a board-certified practicing neurosurgeon who is a national expert in movement disorders, including Parkinson’s disease, and in chronic pain.
“We are incredibly excited to partner with Insightec on ultrasound technology, which has the potential to be a gamechanger in how we treat patients with Alzheimer’s and Parkinson’s disease and how we ensure that each patient is offered the best treatment,” said Pilitsis.
An estimated 6.5 million Americans ages 65 and older are living with Alzheimer’s disease, which is the sixth leading cause of death for those age 65 and above in the U.S., according to the Alzheimer’s Association. Florida has the second highest incidence of Alzheimer’s in the country, with an estimated 580,000 cases. According to the Parkinson’s Foundation, nearly 1 million people in the U.S. are living with the disease, with an estimated four percent of people diagnosed before age 50. Florida is among four states in the U.S. with the highest incidences of Parkinson’s disease.
“Focused ultrasound is an amazing tool that affords us the opportunity to treat many brain diseases in a variety of ways,” said Gregg Fields, Ph.D., interim vice president for research at FAU, executive director of the Institute for Human Health and Disease Intervention (I-Health), and program director for “Research University Alzheimer’s Research Using Exablate Neuro-focused Ultrasound,” a clinical trial collaboration between FAU, Delray Medical Center and Insightec. “We look forward to continuing our collaboration with Insightec on this newest initiative to further explore this technology’s ability to treat some of the most debilitating and costly neurological disorders.”
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