Delcath has developed an investigational system to mechanically isolate the liver from the general circulatory system in order to treat cancer in the liver with high doses of chemotherapeutic drugs while preventing the drugs from causing toxic effects upon other tissues. The Delcath treatment is called Percutaneous Hepatic Perfusion (PHP)™. PHP™ can be performed in an operating room or in a radiology suite under local or general anesthesia. Patients within the trial will receive up to six treatments, usually administered at four-week intervals.
The Delcath Approach:
How It Works!
The Delcath approach to treatment employs a system of catheters and filters to isolate the liver from the general circulatory system and delivers a chemotherapeutic agent directly to the liver. The filters then remove the therapeutic agent from the blood before the blood circulates to the body. In this manner, the tumor is exposed to a high dose of the therapeutic, but all other regions of the body remain protected from the toxic effects.
Clinical Results:
The Delcath system™, or Percutaneous Hepatic Perfusion (PHP)™, has undergone extensive testing in liver cancer patients, and is currently undergoing Phase II and Phase III trials with the drug melphalan against a variety of cancerous tumors in the liver. The Delcath system™ is not currently approved for marketing by the United States Food and Drug Administration, and it cannot be marketed in the United States without FDA approval. Clinical trials have demonstrated that the use of PHP™ in the treatment of cancers in the liver allows significantly higher doses of chemotherapy to be administered to the liver than can be administered with conventional systemic chemotherapy without an increase in associated toxicities.
Current Trials
· Phase III trial using the drug melphalan for patients with metastatic ocular or cutaneous melanoma in the liver
· Phase II trial using the drug melphalan for patients with primary liver cancer (hepatocellular carcinoma) and metastatic tumors in the liver from neuroendocrine cancers and adenocarcinomas
Trial Qualifications
Patients (both male and female) over the age of 18 with primary liver cancer or metastatic ocular melanoma, cutaneous melanoma, neuroendocrine cancer or adenocarcinoma, who have unresectable tumors in the liver
Targeted delivery of high doses of chemotherapy: The Delcath System™ allows delivery of chemotherapy to the liver and removal of the drug from the blood prior to return of the blood from the liver to the patient's circulatory system. The filtration protects other parts of the body from the harmful side-effects of chemotherapy, and allows for much higher doses of drug and, potentially, improved efficacy.
NCI-Led Phase III trials underway: The Phase III protocol received Fast Track designation from the FDA and the trial is being conducted under a Special Protocol Assessment (SPA). Patients are being enrolled at the NCI and the University of Maryland. Delcath will be expanding this trial to additional centers to accelerate enrollment and increase awareness.
5-year CRADA in place: In March 2007 Delcath Systems and the NCI expanded their Cooperative Research and Development Agreement (CRADA) for an additional five years, allowing for collaboration in the joint development and evaluation of The Delcath System™, to continue Phase II and III clinical trials and to evaluate additional agents for use with The Delcath System™.
Repeatability of process, potential with other agents and organs: Unlike regional delivery of chemotherapy to the liver which requires a surgical procedure, The Delcath System™ is non-invasive and, therefore, is repeatable. The Delcath system’s versatility provides it the potential to be used with different therapeutic agents including oxaliplatin and interferon, and for the isolated treatment of cancers in limbs, the kidney and pancreas.
New management team brings focus: Delcath has a new, experienced and capable management team dedicated to advancing development of The Delcath System™. Strategic business experience will be instrumental in building the company and capitalizing on its technology assets.