TIRAT CARMEL, Israel, July 13, 2011 /PRNewswire/ --
Initial Results are Encouraging, Spurring Hope for a Treatment Option With a Lower Rate of Complications
InSightec Ltd., the global leader in MR-guided focused ultrasound technology and the only company to receive FDA approval for its ExAblate® system for treating uterine fibroids, announced today that 23 patients with organ confined low risk prostate cancer have already been treated with its ExAblate® system in clinical trials, showing promising initial results.
The goal of the trials is to demonstrate the feasibility of using the ExAblate® MR-guided Focused Ultrasound (MRgFUS) system in endorectal prostate treatments and to assess the safety and preliminary effectiveness of the treatment. The trials were approved by local ethic committees.
The treatment varies from focal treatment to near whole gland ablation depending on the clinical decision of the investigators. Out of 24 treatments in 23 patients, 5 were near total gland ablation preserving potent patients' urinary sphincter and neurovascular bundles and 18 were focal treatments. None of the treatments (whole gland or focal) triggered Severe Adverse Events during or after treatment and none required post treatment intervention, demonstrating a good safety profile.
Prostate cancer is one of the most commonly diagnosed cancers among men. Approximately 900,000 new cases are diagnosed annually in the world. Treatment options include prostatectomy (surgical removal of the prostate gland), radiation therapy, brachytherapy (implantation of radioactive seeds), and cryotherapy. However, current treatment options are associated with a relatively high level of adverse events among them impotence and incontinence which significantly impair the quality of life of prostate cancer patients.
"We are extremely pleased with the initial results and with the rate of patient recruitment for these trials," says Dr. Kobi Vortman, President and CEO of InSightec. "One of our goals with the ExAblate® prostate cancer program is to demonstrate that an effective treatment does not have to be accompanied by serious adverse events such as impotence and incontinence. We are very encouraged by these early results that give hope that it may be possible in the future to offer prostate cancer patients a treatment option with a lower rate of complications compared to the currently available options."
Clinical trials are on-going at 4 sites: Sapienza University of Rome, Italy, The National Cancer Centre Singapore, The NN Petrov Institute of Oncology, St. Petersburg, Russia, and the Jaslok Hospital and Research Center, Mumbai, India. InSightec will shortly be expanding the prostate clinical trials to additional leading sites.
"Some of my patients express concern regarding the preservation of their sexual function and continence and I have informed them of the MRgFUS treatment as an investigational option for low risk prostate cancer patients", says Associate Professor Christopher Cheng, Head & Senior Consultant, Department of Urology Singapore General Hospital, Singapore. "So far, 9 patients enrolled in the trial at our center with good initial results and we hope that in time this promising technique will become a standard option for low risk prostate cancer patients."
InSightec Ltd. is a privately-held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 120 employees and has invested more than $170 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/
ExAblate® is an Image Guided, Non-invasive, Robotic Acoustic Surgery system. The ExAblate® system is the first to use the MR-guided focused ultrasound technology that combines MRI - to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time - and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is treated and surrounding non targeted tissue is spared. The ExAblate® system was approved by the U.S. Food and Drug Administration in 2004 as a treatment for symptomatic uterine fibroids. Over 8,000 patients have been treated worldwide to date with excellent results. ExAblate® 2000 received the European CE Mark for pain palliation of bone metastases in June 2007 and for Adenomyosis in June 2010.
SOURCE InSightec Ltd