Conducted under an FDA-approved protocol, the single-arm, non-randomized, phase 1 study began in February 2011 and is expected to treat 15 patients before concluding. All patients are being followed for three months. If final results prove successful, Elias anticipates launching a larger, pivotal trial to study the overall safety and long-term efficacy of MR-guided focused ultrasound in treating medication-refractory ET.
Funding for the study is being provided by the Focused Ultrasound Surgery Foundation, which is also underwriting a parallel study at the University of Toronto in Canada. Foundation Chairman, Neal Kassell, MD, says the study's success could lead to other new treatments. "By demonstrating that MR-guided focused ultrasound can treat tissue deep in the brain with great precision and accuracy, we hope to open the door to treating Parkinson's disease, epilepsy and brain tumors. Much work remains to be done, but the path forward is clear," he observed.
Kassell added, "Because the brain poses more complex technical challenges than other organs, success in treating ET will spur advancements in developing new focused ultrasound therapies for the breast, liver, pancreas and prostate, which are less complicated to treat."
Currently, MR-guided focused ultrasound is an FDA-approved therapy for uterine fibroids; it is approved in Europe and elsewhere for the treatment of uterine fibroids and pain associated with bone metastasis. Around the world, clinical trials are treating prostate, breast, bone and uterine tumors.
The UVA study marks the first step in determining if MR-guided focused ultrasound is a safe and effective treatment for ET and if it offers potential benefits beyond current surgical options. The study has enrolled patients who are 18 to 80 years old and who have taken at least two medications that do not control their tremor. Participants, who are followed for three months after tre
|SOURCE Focused Ultrasound Surgery Foundation|
Copyright©2010 PR Newswire.
All rights reserved