On October 11, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported that five new clinical trial sites in the U.S. have been activated in the Company’s global FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma (the FOCUS Trial) (Press release, Delcath Systems, OCT 11, 2016, View Source;p=RssLanding&cat=news&id=2210776 [SID:SID1234515730]). These accredited centers join several other prestigious centers as active participants in the FOCUS Trial. Currently, Delcath now has a total of 8 cancer centers in the U.S. open for patient enrollment in the FOCUS Trial.
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The new participating centers are:
Ohio State University Comprehensive Cancer Center
MD Anderson Cancer Center
Thomas Jefferson University Sidney Kimmel Cancer Center
University of Chicago Comprehensive Cancer Center
University of Maryland Greenebaum Cancer Center
"We are pleased to add these respected cancer research institutions to our FOCUS Trial, and to expand the regional coverage available to patients in the U.S. with ocular melanoma liver metastases," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath. "Interest in the FOCUS Trial has been strong, and we expect to achieve our goal of activating approximately 30 centers in both the U.S. and Europe in the coming months."
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.