Cancers in the Liver
According to the American Cancer Society, cancers in the liver are among the most prevalent and lethal forms of the disease. They can either be primary, originating in the liver, or metastatic, originating elsewhere and traveling to the liver, creating new tumors there. The current treatment armamentarium for cancers in the liver includes surgery, transplantation, systemic chemotherapy, a variety of focal and regional therapies, and radiation therapy, which have varying degrees of invasiveness, efficacy, and side effects.
Developing liver-directed high dose chemotherapy
Delcath is developing a proprietary system for liver-directed high dose chemotherapy. Years of clinical research have gone into refining this system.
Delcath’s proprietary system for liver-directed high dose chemotherapy utilizes the chemotherapeutic agent melphalan hydrochloride at a dose of 3.0 mg/kg, a dose selected based on a Phase 1 clinical trial conducted at the National Cancer Institute in patients with hepatic malignancies. More recently a Phase 3 study compared Delcath’s system for liver directed high dose chemotherapy with melphalan to best alternative care (BAC) for patients with metastatic cancer in the liver caused by ocular and cutaneous melanoma. Data from this trial is pending publication.
Additionally, a recently completed phase 2 clinical trial evaluated liver directed high dose chemotherapy with melphalan in four different tumor types: primary liver cancer, metastatic neuroendocrine tumors (NET), adenocarcinoma, and melanoma. Results of the NET arm were presented at ESMO 2011 (link to bibliography slides). Data from this trial is pending publication.
Disclaimer: In the United States, Delcath’s system for liver-directed high dose chemotherapy is an investigational product and is not approved by the U.S. Food and Drug Administration.