| 2016-10-12 16:06:04|
DCTH 16:06 10/12 10/12/16
Delcath Systems activates first European clinical sites for Focus trial
Delcath Systems announced 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 sites are the first centers in Europe to begin enrolling patients in the FOCUS Trial. 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. The FOCUS Trial is being conducted under a Special Protocol Assessment with the FDA which provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the submission for regulatory approval of Melphalan/HDS.