On October 18, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that patient treatments have begun in the Company’s second global US registration trial investigating Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) in the treatment of patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, OCT 18, 2018, View Source;p=RssLanding&cat=news&id=2372259 [SID1234530000]).
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The University of Tennessee Health Science Center (UTHSC) in collaboration with Methodist University Hospital (MUH) and West Cancer Center (WCC) in Memphis, Tennessee have enrolled the trial’s first patient and treatments have begun by a team led by Dr. Evan S. Glazer. Dr. Glazer, a board certified surgical oncologist, is the principal investigator for the trial at the UTHSC/MUH/WCC location.
The trial, entitled 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, (the ALIGN Trial) will seek to enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe.
"ICC is a deadly form of liver cancer, and the current treatment options have only shown very limited benefit," said Dr. Evan Glazer, "Our team is encouraged by the initial data available for Melphalan/HDS and are pleased to participate in this trial to explore this therapy’s potential as a new treatment option for these patients. We are most excited by the multi-disciplinary approach that this trial takes to help our patients."
"We are delighted to be working with Dr. Glazer and the team in Memphis to initiate The ALIGN Trial," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "In this orphan population where there exists a large unmet need, this trial provides us with a potential second pathway to commercial drug approval in the United States, and if successful we believe will be an important value driver for Delcath."