Delcath Systems

Delcath Systems, Inc. Delcath Systems, Inc. (NASDAQ: DCTH) is a publicly traded specialty pharmaceutical and medical device company[1] that develops percutaneous perfusion technologies for the targeted administration of high-dose chemotherapeutic agents to specific organs or regions of the body. Based in Queensbury, New York, the company has an intellectual property portfolio consisting of 28 patents worldwide. Delcath's Percutaneous Hepatic Perfusion (PHP) is currently undergoing Phase II and Phase III trials against tumors in the liver.[2] Delcath has a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute and has received Fast Track and a Special Protocol Assessment from the Food and Drug Administration for its use of melphalan in treating unresectable liver tumors. PHP, also known as the Delcath System, is tested for the treatment of metastatic melanoma in the liver and for primary liver cancer and metastatic hepatic malignancies from neuroendocrine cancers and adenocarcinomas, as well as patients with melanoma who previously received isolated perfusion. Chemotherapy is usually delivered intravenously, although a number of agents can be administered orally (e.g. specialty drugs, melphalan (trade name Alkeran), busulfan, capecitabine).[3]

Delcath Systems
Formation1988
PurposeSpecialty pharmaceutical
HeadquartersWilmington, Delaware
ServicesPharmaceutical and medical device company focused on oncology
Websitedelcath.com

Phase III melanoma trial enrolling
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References
  1. "Melphalan granted FDA Orphan Drug Designation for treatment of cholangiocarcinoma", News-Medical.Net, 20 July 2015, retrieved 6 October 2015
  2. "Delcath Expands Phase II Multi-Histology Clinical Trial". businesswire.com.
  3. "Specialty Pharmacy Services: An Overview for Oncology Practices". The Journal of Hematology Oncology Pharmacy. 29 July 2015. ISSN 2164-1161. Archived from the original on 7 October 2015. Retrieved 6 October 2015.
  • Delcath official website
  • Clinical trial number NCT00324727 for "Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma" at ClinicalTrials.gov – metastatic melanoma in the liver
  • Clinical trial number NCT00096083 for "Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer" at ClinicalTrials.gov – primary liver cancer and metastatic hepatic malignancies from neuroendocrine cancers and adenocarcinomas
  • Pingpank, James F. Phase I Study of Hepatic Arterial Melphalan Infusion and Hepatic Venous Hemfiltration Using Percutaneously Placed Catheters in Patients with Unresectable Hepatic Malignancies. J Clin Oncol 23:3456-3474.
  • Seidel, Geoffrey D. Part I: Regional Chemotherapy Clinical Studies in Nontraditional Clinical Settings. 10.1188/06.CJON.338-344.



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