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CONTACT: STEVE MARAVETZ
283 Medical Laboratories
Iowa City IA 52242
(319) 335-8037; fax (319) 335-8034
e-mail: steve-maravetz@uiowa.edu

Release: Immediate

UI cancer researchers report promising results from monoclonal antibody study


NOTE TO EDITORS:
Dr. Brian Link is attending the American Society for Clinical Oncology national convention in Los Angeles. He is most readily available for calls from 12:30 p.m. to

1:30 p.m. (Iowa time) today, via the convention press room (312) 765-4622. Ask for him by name or leave a message. Messages can also be left at the Mayfair hotel in Los Angeles, (213) 483-1313). Questions about the study also will be answered by UI cancer researcher Dr. George Weiner (319) 356-2810.


IOWA CITY, Iowa -- A promising new biologic drug for patients with aggressive non-Hodgkins lymphoma can be used safely and effectively in combination with conventional chemotherapy, according to University of Iowa Cancer Center researchers.

The study, reported today to the American Society for Clinical Oncology in Los Angeles, underscores growing evidence about the effectiveness of Rituximab (trade name Rituxan), and offers new promise for patients with B-cell non-Hodgkins lymphoma. Non-Hodgkins lymphoma is a malignant disease that destroys the body's immune system.

Last November, Rituximab became the first monoclonal antibody licensed for cancer treatment in the United States. The FDA's seal of approval followed a previous nationwide study, which showed that Rituximab, when used alone, caused tumor shrinkage in half of participating non-Hodgkins patients who all had lymphoma that recurred following treatment with chemotherapy.

The two studies conducted so far, while promising, "do not mean we have cured cancer," cautioned Dr. Brian Link, a UI Cancer Center researcher and a reporting investigator for the study. "This particular antibody doesn't apply to patients with breast cancer, or lung cancer, or any other form of cancer. However, this study does show that significant results can be safely achieved using monoclonal antibodies in combinationwith standard chemotherapy in patients with recently diagnosed aggressive non-Hodgkins lymphoma."

Link described the results as an important step forward for patients with aggressive non-Hodgkins lymphoma. While scientists don't know yet what the cure rate will be after five years, they hope for significant improvement over current approaches.

Monoclonal antibodies like Rituximab stand at the forefront of new biologic treatments for cancer. Monoclonal antibodies attach to specific cells and, in some cases, activate the body's own immune system to focus on and destroy cancer cells.

The latest study, combining Rituximab and standard chemotherapy, was conducted at the University of Iowa and four other health care centers nationwide. In the study, 97 percent of the participating patients experienced tumor shrinkage, and more than 70 percent had complete resolution of their lymphomas. This compares with an 80 to 90 percent tumor shrinkage rate, and a 50 percent lymphoma resolution rate, from standard chemotherapy.

Furthermore, the Rituximab-chemotherapy combination is relatively safe, since the side-effects were no greater than the side-effects from chemotherapy alone.

The next critical step involves comparing the effectiveness of Rituximab and standard chemotherapy combined against the effectiveness of chemotherapy alone, Link said. "Such a study will allow us to determine what the future standard therapy for non-Hodkins lymphoma will be."

This follow-up comparative study has already begun. In all, 625 patients with aggressive B-cell non-Hodgkins lymphoma will be enrolled at 20 centers nationwide, including the University of Iowa Cancer Center.

For more information about enrolling in the UI portion of the follow-up study, call Dr. Link at (319) 353-8504, or cancer research Dr. George Weiner at (319) 356-2810).

5/18/98