PrintRequest Information
Anti-Mesothelin Immunotoxin Studied for Malignant Mesothelioma Treatment
SS1–PE38:
April 19, 2002 — The federal Food and Drug Administration (FDA) recently granted orphan drug status to SS1–PE38, an antibody toxin being developed by NeoPharm, Inc. for the treatment of malignant mesothelioma, ovarian cancer, and squamous cell lung cancer (a common form of non–small–cell lung cancer usually originating in the bronchi). Orphan status means that the company has two years to exclusively work with the drug, and receives some clinical assistance from the FDA.
SS1–PE38 consists of a bacteria toxin fused to an antibody (an immune system protein that defends the body against toxins). The fused protein retains cell killing activity, but binds only to cells expressing “mesothelin.” Mesothelin is a glycoprotein that may be present on the surface of normal mesothelium or membrane cells in a person’s chest, abdominal cavity, or the pleura encasing the lungs. However, mesothelin is over expressed in many patients with malignant mesothelioma and ovarian cancer. SS1–PE38 is thought to work by targeting the mesothelin antigen on tumor cells, delivering the cytotoxin PE38, and destroying the tumor cell.
NeoPharm is ly conducting a Phase I clinical study to test the effectiveness of SS1–PE38 in the treatment of cancer, including malignant mesothelioma. In a phase I study, researchers test a new drug for the first time in a group of about 20 to 80 people to evaluate its safety, determine a safe dosage range, and identify side effects.
Print