
- Home
- Companies
- Delcath Systems, Inc.
- Products
- Model HEPZATO KIT - Melphalan ...
Model HEPZATO KIT - Melphalan Hydrochloride for Injection/Hepatic Delivery System
Delcath has developed a percutaneous targeted, whole-organ treatment that delivers a select high-dose chemotherapy agent directly to the liver, while controlling systemic side effects, by filtering the chemotherapeutic agent from the blood before returning it to the patient. In the US, our drug/device investigational product is HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system). HEPZATO™ has not been approved by the U.S. Food & Drug Administration. It is under evaluation in a global registration trial (FOCUS Trial) for treatment of patients with hepatic dominant ocular melanoma. In Europe our product is sold under the trade name CHEMOSAT® Hepatic Delivery System (“CHEMOSAT”). CHEMOSAT was CE Marked in 2012, to treat patients with cancers of the liver.
The CHEMOSAT medical device is now available at many of Europe’s leading oncology centers, with over 1,000 treatments conducted to date.
About PHP
In the United States, Delcath’s system for PHP has been evaluated in a Phase 3 trial for patients with unresectable ocular and cutaneous liver metastases. Additional cancers including colorectal cancer, neuroendocrine tumors and in patients with hepatocellular carcinoma (primary liver cancer) have been studied.