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December 5, 2012
18:02 EDTDCTHDelcath Systems announces modification of NDA for liver treatment
Delcath Systems announced that after recent discussions with the FDA, management has elected to modify the label indication it is seeking in its New Drug Application for its proprietary chemosaturation system with melphalan hydrochloride for injection. Although the company's Phase 3 trial demonstrated a very positive signal in patients with liver dominant cutaneous melanoma, based upon a recommendation from the FDA, Delcath has decided to focus the company's NDA indication on the treatment of patients with unresectable metastatic ocular melanoma in the liver. The company believes that its data in ocular melanoma metastases in the liver, coupled with the large unmet need for treatments for this disease, presents the most compelling case for the company's NDA.
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November 10, 2014
06:40 EDTDCTHDelcath Systems treats first patient in Melphalan/HDS Phase 2 trial
Delcath Systems announced that the first treatment has been performed in the company's Global Phase 2 Clinical Program for first-line treatment of patients with unresectable hepatocellular carcinoma, or HCC, or primary liver cancer. A team led by Prof. Dr. med. Thomas J. Vogl, Director of the Institute for Diagnostic and Interventional Radiology at Goethe University Hospital Frankfurt, Germany, treated its first case on November 5. The treating physicians reported that the patient was treated successfully. In Europe, the Company's Phase 2 trial program will investigate the safety and efficacy of Melphalan/HDS treatment without sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response as measured by modified Response Evaluation Criteria in Solid Tumor, or mRECIST, and assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as assess patient-reported clinical outcomes, or quality-of-life. The Company's Phase 2 trial program is expected to include four to seven centers in Europe and the United States, and will seek to enroll approximately 30 patients.

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