Leading U.S. Cancer Centers Join Delcath’s Focus Phase 3 Trial For Patients With Hepatic Dominant Ocular Melanoma

On May 3, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on the treatment of primary and metastatic liver cancers, reported that John Wayne Cancer Institute in Los Angeles, California and Duke Cancer Institute in Durham, North Carolina have been activated as clinical trial sites in the Company’s FOCUS Phase 3 Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS Trial) (Press release, Delcath Systems, MAY 3, 2016, View Source;p=RssLanding&cat=news&id=2164208 [SID:1234511809]). The prestigious centers join Moffitt Cancer Center in Tampa, Florida as active participants in the FOCUS Trial. Delcath plans to include approximately 30 cancer centers in the United States and Europe in the FOCUS Trial.

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"We are pleased to add these highly-respected cancer centers to our FOCUS Phase 3 trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "Interest in participating in the FOCUS trial is high among other major cancer centers in both the United States and Europe, and we expect to announce further trial site activations in the coming months."

About the FOCUS Trial

The FOCUS Trial is 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.