DELCATH ANNOUNCES SPECIAL PROTOCOL ASSESSMENT AGREEMENT WITH FDA FOR PIVOTAL TRIAL WITH MELPHALAN/HDS IN INTRAHEPATIC CHOLANGIOCARCINOMA Company Plans to file 2016 Fourth Quarter and Year End Financial Results by March 30, 2017 NEW YORK, March 27, 2017 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, announces 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.
The pivotal trial is titled “A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma.” 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.
Full details of the registration trial will be made public upon the launch of the study and will be available at www.clinicaltrials.gov.
“We look forward to initiating this important study in ICC under a SPA with the FDA,” said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. “The promising outcomes and observations in this tumor type identified by European investigators at our global Key Opinion Leader Forum last year were discussed at length with the agency, and provide us with considerable confidence in the potential of our therapy as a treatment for ICC. A manuscript of the European investigator data will be submitted to a peer-reviewed journal for publication."
“This pivotal study in ICC is designed to be cost effective and pursued in a financially prudent manner. Given the sequential nature of the trial design, Delcath’s investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year," added Dr. Simpson.
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.
About Special Protocol Assessments The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application. Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.
What happened? One 1:350 reverse split later, and one possible 1:500 reverse split in the works...The "cost effective and pursued in a financially prudent manner" really Rocked!
You've only been a shareholder since October? Many of us have been holding for approx a year and some even more. Doesn't matter how long you've held; neither is it of greater or lesser importance. It may, however, explain why you're not privy to some of the older evidence and concerns. . .
@Rap, Well, except for maybe not putting out any positive news of significance, or any attempt to prop the share price up while HB and others were shorting it into oblivion after the forced-R/S. But, of course, that apparently was part of the plan. The plan that none of us were privy to.
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