DCTH NEWS Jan Jan. 12, 2017 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, announces that patient treatment and data collection for the intrahepatic cholangiocarcinoma (ICC) cohort of its European Phase 2 HCC/ICC study is ongoing, and that the Company will announce interim results for the cohort once the data are fully mature. Additionally, the Company believes that the original goal to obtain an efficacy signal for the Phase 2 ICC cohort has been satisfied by the result of multicenter patient outcomes identified in the retrospective data collection of our commercial ICC cases conducted by our European investigators. These promising outcomes and observations were discussed with Key Opinion Leaders (KOL) at a Delcath -organized medical advisory panel meeting and led to the agreement that PHP® therapy does, indeed, "demonstrate an efficacy signal in ICC and is worthy of full clinical investigation."
The Company also announces that it has accepted an invitation from The Cholangiocarcinoma Foundation (CCF) to present its initial research plans for use of PHP® therapy in the treatment ICC. The CCF is the largest patient advocacy organization devoted to finding a cure and improving the quality of life for patients with cholangiocarcinoma, or bile duct cancers. Company representatives will present a summary of European investigator findings and its clinical development plans for ICC to the Foundation's medical advisory board at the CCF's 2017 Annual Meeting, to be held in Salt Lake City, UT from February 1-3, 2017 . Delcath will also provide a sponsorship grant to support the work of the CCF as part of its participation in the CCF Annual Meeting.
"Though the interim data we expected for ICC cohort in our Phase 2 trial in HCC/ICC are not yet available, the objectives for this study have largely been satisfied by the independent retrospective analysis conducted by our European investigators" said Jennifer K. Simpson , Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath . "The promising outcomes and observations identified at our global KOL forum last year provide us with considerable confidence in the potential of our therapy in the ICC tumor type and helped form our initial research plan. The future research in ICC is designed to be cost effective and pursued in a financially prudent manner."
Dr. Simpson continued, "the CCF is one of the most important organizations for patients diagnosed with bile duct cancers, and the organization has attracted the participation of some of the leading researchers working on this difficult to treat disease. We are delighted with the opportunity to present to KOLs in this space the potential that the European investigators have identified for our therapy in the treatment of ICC."
About ICC ICC is the second most common primary liver tumor and represents approximately 15% of new hepatocellular carcinoma (primary liver cancer or HCC) cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.
About the Cholangiocarcinoma Foundation Now celebrating its 10th Anniversary, CCF is a global 501(c) (3) non-profit organization whose mission is to find a cure and improve the quality of life for those affected by bile duct cancer through advocacy, education, collaboration and research. Visit www.cholangiocarcinoma.org to learn more.
Nothing I state is intended to be a recommendation to buy or sell, opinion only. Readers are solely responsible for how they use the information.
