EDAP Announces Initial Ablatherm-HIFU Treatments at Premiere M.D. Anderson Cancer Center in Ongoing Phase II/III Clinical Trial
Jul 17,2008
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EDAP Announces Initial Ablatherm-HIFU Treatments at Premiere M.D. Anderson Cancer Center in Ongoing Phase II/III Clinical Trial
EDAP Announces Initial Ablatherm-HIFU Treatments at Premiere M.D. Anderson Cancer Center in Ongoing Phase II/III Clinical Trial
EDAP Announces Initial Ablatherm-HIFU Treatments at Premiere M.D. Anderson Cancer Center in Ongoing Phase II/III Clinical TrialLYON, France, July 17, 2008 - EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, announced today that urologists at the University of Texas M.D. Anderson Cancer Center have treated their first two localized prostate cancer patients with Ablatherm-HIFU (high intensity focused ultrasound). The prestigious center is one of 13 Ablatherm sites participating in ENLIGHT, EDAP's ongoing Phase II/III clinical trial to evaluate the minimally invasive, robotized treatment in patients with localized prostate cancer.
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 at the Center said, "We are delighted to participate in EDAP's ENLIGHT trial, particularly because M.D. Anderson is always looking at novel treatment approaches with the potential to provide greater efficacy, fewer side effects, and better quality of life for cancer patients. 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. "
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "We are fortunate to have the world reknown 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."
About M.D. Anderson Cancer Center
M.D. Anderson, one of the world's most respected cancer centers, has built a reputation for excellence over the past 60 years through its devotion to patient care, and clinical and basic science research by educating the next generation of physicians and striving to prevent human malignancy. U.S. News and World Report's "America's Best Hospitals" survey ranked M. D. Anderson as the #1 hospital in the nation for cancer care in 2008. The magazine has given M.D. Anderson the number one ranking in seven of the past eight years. This same survey has also consistently ranked M. D. Anderson's Department of Urology as one of the top 10 Urology centers in the Nation.
About the ENLIGHT Study
The Phase II/III prospective non-inferiority study is designed to evaluate the safety and efficacy of EDAP's Ablatherm-HIFU system versus Cryotherapy for the treatment of low-risk, localized prostate cancer. The clinical trial is currently enrolling men over age 60 diagnosed with clinical stage T1a, b, or c or T2a localized prostate cancer. The primary outcome measure of the trial is statistically significant reduction and stability of the prostate-specific antigen (PSA) throughout a 24-month follow-up period. Details of the study and background on Ablatherm-HIFU can be found by searching for "Ablatherm" online at www.ClinicalTrials.gov.
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the company, please visit http://www.edap-tms.com and http://www.hifu-planet.com or http://www.urotoday.com/HIFU.
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 at the Center said, "We are delighted to participate in EDAP's ENLIGHT trial, particularly because M.D. Anderson is always looking at novel treatment approaches with the potential to provide greater efficacy, fewer side effects, and better quality of life for cancer patients. 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. "
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "We are fortunate to have the world reknown 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."
About M.D. Anderson Cancer Center
M.D. Anderson, one of the world's most respected cancer centers, has built a reputation for excellence over the past 60 years through its devotion to patient care, and clinical and basic science research by educating the next generation of physicians and striving to prevent human malignancy. U.S. News and World Report's "America's Best Hospitals" survey ranked M. D. Anderson as the #1 hospital in the nation for cancer care in 2008. The magazine has given M.D. Anderson the number one ranking in seven of the past eight years. This same survey has also consistently ranked M. D. Anderson's Department of Urology as one of the top 10 Urology centers in the Nation.
About the ENLIGHT Study
The Phase II/III prospective non-inferiority study is designed to evaluate the safety and efficacy of EDAP's Ablatherm-HIFU system versus Cryotherapy for the treatment of low-risk, localized prostate cancer. The clinical trial is currently enrolling men over age 60 diagnosed with clinical stage T1a, b, or c or T2a localized prostate cancer. The primary outcome measure of the trial is statistically significant reduction and stability of the prostate-specific antigen (PSA) throughout a 24-month follow-up period. Details of the study and background on Ablatherm-HIFU can be found by searching for "Ablatherm" online at www.ClinicalTrials.gov.
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the company, please visit http://www.edap-tms.com and http://www.hifu-planet.com or http://www.urotoday.com/HIFU.