July 17, 2008 - Urologists at the University of Texas M.D. Anderson Cancer Center treated their first two localized prostate cancer patients with Ablatherm-HIFU (high-intensity focused ultrasound), as part of ENLIGHT, an ongoing Phase II/III clinical trial.
The trial, led by EDAP, is designed to evaluate the minimally invasive, robotized treatment in patients with localized prostate cancer. "We see great promise for Ablatherm-HIFU as a minimally invasive treatment that targets localized prostate cancer, which could effectively treat the disease and allow patients to resume their day-to-day activities with minimal or no downtime. ENLIGHT provides an opportunity to rigorously evaluate this potential," said John F. Ward, M.D., F.A.C.S., assistant professor, Department of Urology at M.D. Anderson Cancer Center, and principle investigator of the trial.
Marc Oczachowski, EDAP's CEO, commented, "We are fortunate to have the world renown M.D. Anderson Cancer Center participating in the ENLIGHT trial which has received Investigational Device Exemption by the FDA. The center’s initial treatments with Ablatherm-HIFU mark a significant milestone in our development program, and additional patients have been scheduled to receive our minimally invasive treatment in the coming weeks. Attracting leading American cancer centers is part of our strategy to gain HIFU visibility and potentially accelerate patient enrollment at all participating sites as we advance towards submission for FDA approval in the U.S. We are confident that the validation from our participating sites, in conjunction with ongoing momentum from our marketing and referral program, continues to generate increased patient awareness of HIFU."