Full Press Release Details
Delcath Systems, Inc. Announces Promising Results from Independent Study on Repeated Hepatic Chemosaturation for Liver
NEW YORK, August 26, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ( Company or Delcath ),
an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of an independent study conducted by investigators at the University Hospital of Leipzig, Germany, in the European
Society for Medical Oncology journal of Gastrointestinal Oncology. The study, titled Hepatic chemosaturation with melphalan in patients with primary or secondary liver tumors with or without extrahepatic tumor manifestation, highlights
the efficacy and safety of repeated chemosaturation treatments using Delcath s CHEMOSAT Hepatic Delivery System.
Key Findings from the Independent Study:
Figure 1: Individual changes in tumor sizes during CHEMOSAT treatment. (A) Individual changes in tumor sizes
during CHEMOSAT treatment. On the y-axis the change in tumor size is indicated according to the baseline lesions. (B) Waterfall plot of changes in the size of target lesions at the end of observation.
Dashed lines are thresholds for hepatic PD, hepatic SD, hepatic PR and hepatic CR. CR, complete response; HCC, hepatocellular carcinoma; ICC, intrahepatic cholangiocellular carcinoma; other, ciliary body melanoma, angiosarcoma, tonsil and pancreatic
carcinoma; PD, progressive disease; PR, partial response; SD, stable disease; UM, uveal melanoma.
Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented,
The results of this independent study reinforce the potential of our CHEMOSAT Hepatic Delivery System as an essential tool in the management of primary and secondary liver tumors, particularly for patients with limited treatment options. The
high rate of disease control observed, even in patients with extrahepatic tumor spread, underscores the importance of continuing to explore and refine this treatment approach in larger, prospective trials.
The publication is available here.
Systems, Inc., HEPZATO KIT and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic
liver cancers. The company s proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and
CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and
associated side effects during a PHP procedure.
In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated
and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic
circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful
tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases
affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information,
including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is
approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the
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