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Coulter Initiates Expanded Access Program For Bexxar For Non-Hodgkin’s Lymphoma PALO ALTO, CA -- Sept. 29, 1998 -- Coulter Pharmaceutical Inc. has initiated its expanded access program for Bexxar(TM) (iodine I 131 tositumomab), the company's lead cancer therapeutic in development for the treatment of low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The program was established by the company in response to requests from physicians and patients for continued access to Bexxar during the period prior to potential FDA marketing approval. The inclusion criteria for the expanded access program is broad, allowing for the treatment of low-grade or transformed low-grade NHL patients who have undergone at least one prior chemotherapy. The program will build gradually and is expected to eventually include over 100 community and academic oncology centres across the United States. Bexxar, which is an antibody conjugated to iodine 131, attaches to a protein found only on the surface of B-cells, including both non-Hodgkin's lymphoma B-cells and some normal B-cells. It is believed that through this targeted approach, the tumour cells receive a greater concentration of the therapeutic radiation from Bexxar relative to normal tissues. The antibody treatment is administered in a regimen which consists of two intravenous doses given about one week apart -- first a dosimetric dose followed by a therapeutic dose. This is in contrast to conventional chemotherapy where treatment is given repeatedly over several months. Non-Hodgkin's lymphoma is a form of cancer that affects the blood and lymph tissues. NHL currently is the sixth-leading cause of death among cancers in the U.S. and has the second fastest growing mortality rate. According to statistics from the National Cancer Institute, approximately 270,000 people are afflicted with NHL in the United States alone. Of the total, the company estimates that approximately 140,000 people have low-grade or transformed low-grade disease. There are approximately 54,000 new cases of NHL diagnosed each year. E-mail this page to a friend or colleague! To print, use this version