Delcath Announces Special Protocol Agreement Modification With FDA
Delcath Systems, Inc. (DCTH)
US:NASDAQ Investor Relations:
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Source: GlobeNewswire
NEW YORK, Jan. 10, 2018 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that it has concluded a modification agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (The FOCUS Trial). The modification agreement revises the FOCUS trial’s eligibility criteria to permit a greater extent of extra-hepatic disease by removing the size restriction, number and location of extra-hepatic lesions, in conjunction with a treatment plan for the extra-hepatic metastases. Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, “We requested this protocol modification to improve patient access to this important clinical trial for appropriately sel
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