Delcath Systems, Inc., incorporated on August 5, 1988, is a late-stage clinical development company with early commercial activity in Europe focused on cancers of the liver. The Company is a specialty pharmaceutical and medical device company developing its product, Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS). The Company's system delivers and filters melphalan hydrochloride, which is marketed as a device under the trade name Delcath Hepatic CHEMOSAT Delivery System for Melphalan (CHEMOSAT). The Company's focus is on the execution of the clinical development program (CDP) in ocular melanoma liver metastases (mOM), intrahepatic cholangiocarncinoma (ICC), hepatocellular carcinoma (HCC or primary liver) and other cancers that are metastatic to the liver.
The Company's clinical development program for CHEMOSAT/Melphalan/HDS consists of a Global Phase III clinical trial investigating overall survival in ocular melanoma liver metastases, and a Global Phase II clinical trial program investigating Melphalan/HDS with and without sorafenib in HCC. The Company's CDP also includes sponsorship of select investigator initiated trials (IITs) in HCC and colorectal cancer liver metastases (mCRC) and the establishment of a commercial registry for CHEMOSAT non-clinical commercial cases performed in Europe. In Europe, the Company's CHEMOSAT product is regulated as a Class IIb medical device.
The Company has completed the Phase III clinical trial and multi-arm Phase II clinical trial of the Melphalan/HDS with melphalan in patients with liver cancers. The Company focus on its CDP is to generate clinical data for the CHEMOSAT/Melphalan/HDS in various disease states. The Company's CDP supports clinical adoption of and reimbursement for CHEMOSAT in Europe and supports regulatory approvals in various jurisdictions, including the United States.
The Company competes with Covidian, Biocompatibles, Merit, CeleNova, SirTex, AngioDynamics, Onyx Pharmaceuticals and GlaxoSmithKline plc.
1633 Broadway Ste 22C
The company trades on NCM exchange. The company headquarter is located in New York, United States. The company was established in the 1988.| Ticker | DCTH |
| Long Name | Delcath Systems, Inc. |
| Short Name | Delcath Systems, Inc. |