On October 12, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that five clinical sites in Europe have been activated and are open for patient enrollment in the Company’s FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial) (Press release, Delcath Systems, OCT 12, 2016, View Source;p=RssLanding&cat=news&id=2211160 [SID:SID1234515764]). The sites are the first centers in Europe to begin enrolling patients in the FOCUS Trial. One center, Charité University Hospital in Berlin, Germany, has treated its first patient. Delcath now has 13 centers in the U.S. and Europe open for patient recruitment, and expects up to 30 centers will participate in the FOCUS Trial.
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The following highly-accredited European centers are now open for patient enrollment:
Austria
University Hospital, Graz
Germany
Charité University Hospital, Berlin
University Hospital, Marburg
University Hospital, Regensburg
United Kingdom
University Hospital Southampton
"We are pleased to add these highly respected European cancer centers to our FOCUS Trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath. "This expansion allows Delcath to work with the some of Europe’s top universities and institutes while providing some of Europe’s leading clinicians with first-hand knowledge of our therapy, which will continue to be of great value as we expand our commercial footprint for CHEMOSAT as a treatment for ocular melanoma in Europe."
About the FOCUS Trial
The FOCUS Trial is a global Phase 3 clinical study evaluating the safety, efficacy and pharmacokinetic profile of the Company’s Melphalan/HDS system versus best alternative care in 240 patients with ocular melanoma liver metastases. The FOCUS Trial’s primary endpoint is a comparison of overall survival between the two study arms; secondary and exploratory endpoints include progression-free survival, overall response rate and quality-of-life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS.