Delcath Reaches SPA Deal With FDA On Pivotal Trial Of Melphalan Hydrochloride

(RTTNews) - Delcath Systems Inc. (DCTH) said that it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of Delcath's pivotal trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC). The SPA agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS.

Under the SPA, the study will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. The Company expects to initiate the study in the Fall of 2017.

Separately, the Company announces that it intends to file financial results for the three and 12 months ending December 31, 2016 on Form 10-K with the U.S. Securities and Exchange Committee on or before March 30, 2017.