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Delcath Systems, Inc. Announces Third Quarter 2020 Results
Conference Call Today at 8:30am Eastern Time NEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology
About this update from Delcath Systems, Inc.
[{"type":"text","content":"Conference Call Today at 8:30am Eastern Time\nNEW YORK, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the third quarter ended September 30, 2020.\n Recent Business Highlights During and since the third quarter of 2020, the company: Strengthened the executive team with the appointment of Gerard Michel as Chief Executive Officer.Announced the conditional acceptance by the FDA of the trade name HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system) for Melphalan/HDS.Announced the treatment of the final patient in the FOCUS trial; to date, 91 patients have been treated with a total of 356 treatments.Confirmed the expected announcement of topline data in early 2021 and updated the expected NDA submission timing to the first quarter of 2022.Provided details that for analytical purposes, the FOCUS trial should demonstrate an overall response rate of at least 21% to show superiority over a meta-analysis of immuno-oncology trials in metastatic ocular melanoma (mOM).Held a key opinion leader call with Dr. Mark Burgmans, Head of Interventional Radiology at the Leiden University Medical Center, to discuss the results of a prospective study, published in August 2020 in the Annals of Surgical Oncology, which reported an overall response rate of 72% in patients with metastatic ocular melanoma with metastases confined to the liver. As stated in the publication, treating the patients early in the disease cycle and the exclusion of patients with extra-hepatic disease likely contributed to the favorable outcome observed in this study. Observed safety events were primarily hematological in nature and deemed to be expected and manageable. “I have joined the Delcath team at an exciting moment in the company’s history as we approach the announcement of the FOCUS trial’s topline results and the evidence continues to build that HEPZATO has the potential to be an important treatment for metastatic ocular melanoma,” said Gerard Michel, CEO of Delcath. “2021 will represent an inflection point for the company as we execute on four key priorities including compiling the HEPZATO KIT NDA, preparing for commercialization, raising awareness with inv...