FDA approves launch of Parkinson's disease clinical trial
The Foundation's Parkinson's disease research initiative achieved a new milestone last week when InSightec received permission from the U.S. Food and Drug Administration to launch a Phase I clinical trial using its focused ultrasound technology to treat 30 patients with medication-resistant tremor of Parkinson's disease.
The Focused Ultrasound Foundation is a sponsor of the new randomized control trial which will take place at the University of Virginia. W. Jeffrey Elias, MD, the neurosurgeon who led the landmark essential tremor study, will be the principal investigator.
Brain Program's mini-workshop called "a landmark example" of academic-industrial collaboration
Hands-on problem solving was a key part of the Brain Program mini-workshop. Shown during a work session at the UVA Focused Ultrasound Center are: (standing left to right) Dennis Parker (Utah), Chang-Sheng Mei (Harvard) and Craig Meyer (UVA); (seated, left to right) Kim Butts-Pauley (Stanford), Anthony Vu (GE Healthcare), Matt Eames (FUS Foundation) and Eyal Zadicario (InSightec).
On July 23 and 24, the Focused Ultrasound Foundation's Brain Program hosted its first invitational mini-workshop to tackle important imaging problems with the help of a world-class team of MR experts from academia and industry. This workshop was a highly successful collaborative problem-solving session that generated solutions for improving the efficiency and safety of transcranial focused ultrasound treatments.
"Some of the solutions identified during the workshop will be applied in the very next brain patient procedure," says John Snell, PhD, Brain Program technical director. "The solutions are expected to reduce treatment time by improving the quality of the MRI scans."
Conducted at the University of Virginia's Darden School of Business, the workshop brought together representatives from industry (InSightec and GE Healthcare) and neurosurgeons, MR engineers and MR physicists from leading academic centers in the U.S. (Harvard, Stanford, Utah, the University of California San Francisco, UVA and Vanderbilt) and Europe (Institut Langevin and University Children's Hospital, Zurich).
Following the workshop, Eyal Zadicario, director of Neuro Programs for InSightec, wrote, "Getting this team together is a great achievement for the Foundation and a landmark example of collaboration between academia and industry."
Journal of Focused Ultrasound is a new channel for publishing and disseminating research
The Journal of Therapeutic Ultrasound (JTU) has launched its website and received its first manuscript for peer-review, marking the opening of an important new channel through which focused ultrasound researchers can publish their findings and make them quickly and broadly accessible to other stakeholders.
The new online, open access journal represents a collaboration of the Focused Ultrasound Foundation, the International Society for Therapeutic Ultrasound and the highly regarded internet publisher BioMed Central, Ltd. The JTU will cover all aspects of therapeutic focused ultrasound research and place special emphasis on translational and clinical studies.
Interns complete Brain Program assignments during a very productive summer
Focused Ultrasound Foundation 2012 Summer Interns
(Left to right) Front row: Matthew Hantzmon, JT Booth and Graham Rolph; Back row: Yiqi Cao and Alisha Geldert
The Focused Ultrasound Foundation was proud to have five very bright and gifted undergraduate scientists-in-training tackle a variety of Brain Program projects as our first-ever summer interns.
"We established the internships to foster interest among the next generation of researchers in the development of focused ultrasound as a clinical tool and to address real-world challenges, the conquering of which could expedite adoption," explains Matt Eames, PhD, Director of Extramural Research. "We are all very impressed by what this group accomplished. Each project represents a valuable contribution to the field of focused ultrasound."
(Click on each name to learn about what each intern accomplished during the summer of 2012.)
Working on individual projects:
Yiqi Cao, Biomedical Engineering major, University of Virginia, Class of 2015 Summer assignment: Investigate the potential of sonodynamic therapy Potential impact: Sonodynamic therapy may expand the trans-cranial treatment envelope for FUS, allowing the treatment of more clinical indications.
Matthew Hantzmon, Chemical Engineering major, Northwestern University, Class of 2015 Summer assignment: Find the most accurate calculation for lesion volume Potential impact: Algorithm could help guide clinicians' selection of treatment parameters for clinical transcranial MR-guided focused ultrasound and save up to an hour in treatment time for brain cases (25% reduced treatment time).
Graham Rolph, Aeronautical Engineering major, California Polytechnic State University, Class of 2016 Summer assignment: Install a Picture Archiving and Communications System; co-register MR and CT data with the National Cancer Institute Potential impact: Publicly available datasets will allow researchers free access to valuable and rare clinical data for treatment simulations, which will help improve focused ultrasound technology.
Working on a collaborative assignment:
Richard (JT) Booth, Computer Science/Engineering major, Harvey Mudd College, Class of 2015 Alisha Geldert, Biomedical Engineering major, University of Virginia, Class of 2015 Summer assignment: Develop an adaptive model to predict temperature elevation of brain tissue based on skull parameters Potential impact: Technical analysis software will help provide a better understanding of treatment accuracy, which will lead to improved clinical treatments.
Jin Woo Chang, MD and Joseph Jankovic, MD join Movement Disorder Steering Committee
Two renown clinical experts have joined the Foundation’s Movement Disorders Steering Committee, the advisory group that is guiding focused ultrasound research related to Parkinson’s disease, essential tremor and other movement disorders.
Jin Woo Chang, MD, PhD
Jin Woo Chang, MD, PhD of Yonsei University College of Medicine in Seoul, South Korea – One of the most distinguished and influential neuosurgeons in Korea and the Asia Pacific Region, Chang serves as professor and chairman of the Department of Neurosurgery and is director of the Brain Research Institute at Yonsei. He is president of several medical societies, including the Korean Society for Stereotactic and Functional Neurosurgery, the International Society of Reconstructive Neurosurgery and the Asian Australasian Society for Stereotactic and Functional Neurosurgery. He is also vice secretary and treasurer of the World Society for Stereotactic and Functional Neurosurgery.
Chang is currently serving as principal investigator of a pilot clinical trial using focused ultrasound to treat essential tremor.
Joseph Jankovic, MD of the Baylor College of Medicine in Houston, Texas – An internationally recognized movement disorders expert, Jankovic is a professor of Neurology and Distinguished Chair in Movement Disorders at Baylor. He is also the founder and director of the Parkinson's Disease Center and Movement Disorders Clinic and co-director of Parkinson's Disease Research Laboratory.
Joseph Jankovic, MD
Jankovic has been the principal investigator of more than a hundred clinical trials, and his pioneering research on drugs for Parkinsonian disorders and hyperkinetic movement disorders has led to their approval by the U.S. Food and Drug Administration. He is a past president of the Movement Disorder Society, and an Honorary Member of the American Neurological Association.
In his advisory roles, Jankovic serves as a member of the executive scientific advisory board of The Michael J. Fox Foundation for Parkinson’s Research and the National Parkinson Foundation Clinical and Scientific Advisory Board. He has served on editorial boards of Neurology, Movement Disorders, Journal of Neurology Neurosurgery and Psychiatry, Acta Neurologica Scandinavica, Journal of Neurological Sciences, Neurology Medlink, Clinical Neuropharmacology, Neurotherapeutic, Expert Review of Neurotherapeutics, Journal of Parkinson’s Disease and other journals.
Other members of the Foundation’s Movement Disorders Steering Committee are: G. Frederick Wooten, Jr., MD of the University of Virginia (Chairman); Antonio DeSalles, MD, PhD of the University of California Los Angeles; W. Jeffrey Elias, MD of the University of Virginia; Andres Lozano, MD, PhD of the University of Toronto; and James C. Torner, PhD of the University of Iowa.
Jessica Foley and Emily McDuffie join Foundation team
Jessica Foley, PhD
Jessica Foley, PhD, Scientific Director, is returning to the focused ultrasound community after completing a one-year American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellowship at the National Science Foundation in Washington, DC. Prior to that, she spent three years working for InSightec as Neuro Projects Manager and Clinical Marketing Manager.
Foley's career in focused ultrasound began at the University of Washington where she completed her doctorate in bioengineering and wrote her dissertation on the biological effects of focused ultrasound on peripheral nerves. Her 11-year career in the field has spanned the academic, industrial and government worlds. Such breadth of experience gives a unique perspective and insight that will be critical to the Foundation, particularly in the areas of regulatory affairs and reimbursement.
As the Foundation's Scientific Director, Foley will cultivate relationships and strategic partnerships with governmental policy-makers and regulatory agencies, including the Food and Drug Administration, and with disease-specific foundations whose interests are similar to those of the Foundation. She will represent and advocate for the Foundation and the focused ultrasound community among a wide variety of stakeholders.
Emily McDuffie, Development Associate, is supporting the foundation's fundraising efforts and invitational events for donors. Prior to joining the Foundation, McDuffie spent six years in program management and development for Children, Incorporated, a non-profit child sponsorship organization. She is a 2006 graduate of Randolph-Macon College in Virginia.
Foundation Council welcomes Norwood and Marguerite Davis
Norwood and Marguerite Davis
Norwood and Marguerite Davis of Richmond, Virginia, have joined the Foundation Council, a select group of advisors and advocates who work closely with the Board of Directors to advance the Foundation's mission. Welcoming them, Foundation Chairman Neal F. Kassell, MD said, "Norwood and Marguerite's interest in cancer research and leadership in the philanthropic community will be extremely beneficial to our work. In addition, Norwood's experience and knowledge of the insurance industry will provide insights and guidance with regards to the Foundation's reimbursement programs and initiatives."
Norwood Davis is the former Chairman and CEO of Trigon Healthcare and a former director of a number of public and privately held companies. He has held leadership positions with numerous nonprofit boards, including Hampden Sydney College, the Commonwealth Foundation for Cancer Research, Virginia Commonwealth University Health Services Foundation and Virginia Commonwealth University Massey Cancer Center. He is a graduate of Hampden Sydney College and the University of Virginia School of Law.
Marguerite Davis is owner of Davis, Uniquely Beautiful Jewelry, a fine jewelry boutique in Richmond, VA. She is currently in a leadership position on the Foundation Board for the Virginia Commonwealth University School of Engineering and has served on the Board of the Virginia Engineering Foundation at the University of Virginia and the Board of Trustees for Hampden Sydney College. She is a graduate of the University of Virginia and the Gemological Institute of America.
TRAIN inventory lists Foundation among organizations with a venture philanthropy focus
FasterCures has announced the availability of its new The Research Acceleration and Innovation Network (TRAIN) Inventory. The inventory, which lists the Focused Ultrasound Foundation, catalogues the operational and partnering practices of nonprofit disease research foundations, particularly those with a venture philanthropy focus. FasterCures says the inventory is designed to help potential collaborators better understand the landscape of disease research foundations and engage in meaningful partnerships with them.
EDAP concludes follow-up phase of its U.S. prostate cancer study
French focused ultrasound device maker, EDAP TMS SA, reports that the two-year follow up phase has concluded for its multi-center U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Data analysis is now underway, and the company is preparing a comprehensive Premarket Approval (PMA) submission, which is the next step in the FDA approval process.
FDA approves launch of Celsion/Phillips bone metastasis study using focal drug delivery
Thanks to recent clearance by the U.S. Food and Drug Administration, Phillips Healthcare and Celsion Corporation are set to launch a Phase II clinical study that will assess the use of focused ultrasound and chemotherapy in the palliation of painful bone metastases caused by lung, prostate or breast cancers. The study, which is expected to start in late 2012, will use Philips' MR-guided focused ultrasound system, the Sonalleve, and Celsion's investigational drug, ThermoDox – a form of doxirubicin encapsulated in a heat-sensitive liposome. The Sonalleve will be used to precisely and noninvasively target bone tumors with acoustic energy, creating sufficient heat to activate ThermoDox and trigger the release of high concentrations of doxorubicin in the targeted treatment area.
Study advances understanding of focal drug delivery to the brain
In a preclinical study published in the Journal of Controlled Release, Harvard Medical School researchers investigated the kinetics of blood-brain barrier permeability and drug delivery following single and double focused ultrasound sonications. They found that delivery of the chemotherapy agent, doxorubicin, was significantly greater when one focused ultrasound sonication was used and 1.5-fold higher when a second sonication was administered ten minutes later. Study data suggests that MRI contrast agent Gd-DTPA may be useful as a surrogate tracer in estimating drug delivery to the brain following focused ultrasound-induced blood-brain barrier disruption.
Lead author on the study isJuyoung Park, PhD, a research fellow in radiology at Brigham and Women's Hospital and Harvard Medical School. Co-authors are Yongzhi Zhang, MD; Natalia Vykhodtseva, PhD; Ferenc A. Jolesz, MD; and Nathan J. McDannold, PhD.
Researchers develop calibration techniques for brain treatments using pulsed focused ultrasound
Seung-Schik Yoo, PhD, of Harvard Medical School and Ulsan National Institute of Science and Technology in Korea, and his colleagues have been pioneering the use of focused ultrasound in the neuromodulation of brain function, a pulse-mode approach they believe holds great therapeutic potential. In the August 10, 2012 issue of International Journal of Imaging Systems and Technology, they describe the mechanical and MR-based calibration techniques they have developed to define the local coordinates of a sonication focal point. The researchers used the method to apply pulse-mode focused ultrasound in preclinical studies and successfully stimulated the motor cortex. They believe the techniques are readily adaptable for the transcranial application of focused ultrasound to the intact human brain.
Yoo's study co-authors are Hyungmin Kim, PhD of Harvard Medical School and Korea University; Alan Chiu of Harvard Medical School; and Shinsuk Park, PhD of Korea University.
New metamaterial device focuses sound waves and may eliminate need for transducers of different sizes
A cover article in The Journal of Applied Physics describes how a team of researchers at Penn State Materials Research Institute designed and computationally tested a device constructed of a manmade metamaterial that can manipulate a variety of sound waves. Expected to benefit almost all current sonic and ultrasonic applications, the invention could lead to more accurate and efficient high intensity focused ultrasound therapies.
Built on gradient-index phononic crystals — an array of steel pins embedded in epoxy in a particular pattern – the new device can shrink or expand the aperture of an acoustic beam with minimum energy loss and waveform distortion. Researchers believe the lens will eliminate the need and expense of having transducers of different sizes on hand for research and surgical use.
Sz-Chin Steven Lin, PhD, a postdoctoral scholar at Penn State, is lead author of the paper. Co-authors are Bernhard R. Tittmann, PhD and Tony Jun Huang, PhD.
An interview with Focused Ultrasound Foundation Chairman Neal Kassell, MD in the August 21, 2012 issue of C-ville Weekly. The article provides an excellent overview of the Focused Ultrasound Foundation's history, mission and unique approach to venture philanthropy – a new research funding model developed with the goal of making better treatments available to patients in the shortest time possible.
The title of a feature story in the August 13, 2012 issue of The Jerusalem Post. The article chronicles the history and evolution of InSightec and opens with a brief profile of Phyllis Walker, a patient in the essential tremor trial conducted during 2011 at the University of Virginia. Yoav Medan, PhD, a member of the core team that pioneered focused ultrasound at InSightec, is spotlighted in the article.
September 15-19: Cardiovascular and Interventional Radiologic Society of Europe (CIRSE) 2012, Lisbon, Portugal
This trend-setting, dynamic and service-oriented event is the largest and most comprehensive congress in the field of minimally invasive image-guided therapies. The program is designed around seven main themes: Vascular Interventions, Transcatheter Embolization, Interventional Oncology, Neuro Interventions, Non-Vascular Interventions, IR Management and Imaging.
October 5-6: 2nd International Meeting of the Society for Intestital Delivery of Therapeutics (SCIDOT), Chicago, IL, USA
Focused Ultrasound Foundation Medical Director Arik Hananel, MD will be a presenter at SCIDOT. The meeting, which will be held at the Sheraton Hotel and Towers will provide broad insight into the latest technological developments regarding medical devices, therapeutic agents, imaging methods and imaging agents in the field of targeted delivery of drugs and novel therapeutic agents to the central nervous system. The latest news from clinical trials will also be presented.
October 14-17: 3rd International Symposium on Focused Ultrasound, Bethesda, MD, USA
Organized by the Focused Ultrasound Foundation, the Symposium is a global forum covering state-of-the-art clinical applications of image-guided focused ultrasound. Topics include applications in: the brain, breast, liver, pancreas and prostate; uterine fibroids and fertility; bone tumors; back and neck pain; and emerging applications. More than 170 oral and poster presentations will address the latest advances using both MRI and ultrasound guidance.
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