EDAP Adds World Renowned Cancer Center for Phase II/III
Ablatherm-HIFU Clinical Trial
LYON, France, April 10, 2008 (PRIME NEWSWIRE) -- EDAP TMS SA
(Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced
today that it has received Institutional Review Board (IRB) approval
for Memorial Sloan-Kettering Cancer Center in New York City to
participate in EDAP's ongoing Phase II/III clinical trial of
Ablatherm(r)-High Intensity Focused Ultrasound (HIFU). The trial
compares the outcomes of Ablatherm and Cryotherapy for the treatment of
low-risk prostate cancer. This IRB approval brings the total number of
active sites in the trial to 10 HIFU sites and 6 Cryotherapy sites.
"This clinical trial will evaluate the safety and efficacy
of HIFU for the treatment of prostate cancer," said Dr. James Eastham,
Attending Surgeon in the Urology Service at Memorial Sloan-Kettering.
"Results from Europe have been encouraging, and it is hoped that they
will be substantiated by this study and help further define the role of
the procedure both within the United States and around the world."
John Rewcastle, Ph.D., Medical Director of EDAP TMS,
commented, "Memorial Sloan-Kettering is one of the most respected and
active prostate cancer treatment sites in the world. Their
participation in the ENLIGHT study represents a significant milestone
for EDAP as accrual is expected to rapidly progress due to the large
prostate cancer patient population in Manhattan and the surrounding
boroughs."
Marc Oczachowski, EDAP's Chief Executive Officer, stated,
"We are extremely pleased to add a world premier center like Memorial
Sloan-Kettering to participate in the prospective non-inferiority trial
evaluating Ablatherm-HIFU versus Cryotherapy. As a major U.S. leader in
the treatment of prostate cancer, Memorial Sloan-Kettering further
validates the potential of our non-invasive approach to treating
localized prostate cancers and adds credibility to our technology
overall. We believe that the quality of participating sites in this
trial enhances EDAP's profile among urologists, which is supported by
the continued momentum for our patient awareness trial program to
accelerate our screening and recruitment of patients."
About the Study
The 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 will be a 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 online at
www.ClinicalTrials.gov by searching for "Ablatherm."
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 ,
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CONTACT: EDAP TMS SA
Investor Relations / Legal Affairs:
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
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