Genitope Corporation Phase 2 Data Using Personalized Immunotherapy for Initial Treatment of Non-Hodgkin's Lymphoma Presented at American Society of Clinical Oncology Meeting.

Business Editors/Health & Medical Writers

REDWOOD CITY, Calif.--(BW HealthWire)--May 20, 2002

Genitope Corporation announced the results from a Phase 2 clinical trial regarding the use of its GTOP-99 personalized immunotherapy in patients with advanced stage follicular non-Hodgkin's lymphoma (f-NHL) who have not previously received chemotherapy for their disease in a presentation at the 38th Annual American Society of Clinical Oncology Meeting yesterday in Orlando, Florida. F-NHL is an incurable disease and initial chemotherapy is typically deferred for patients who are asymptomatic at diagnosis. This is the first study to demonstrate that a personalized immunotherapy, when used as the initial treatment for patients with f-NHL, can induce tumor-specific antibody and T-cell immune responses.

The study involved 16 asymptomatic f-NHL patients treated with GTOP-99, a personalized immunotherapy also referred to as a personalized idiotype vaccine. GTOP-99 was developed by combining each patient's tumor-specific marker, "idiotype" (Id), with keyhole limpet hemocyanin (KLH), an immunogenic carrier protein. Each patient received a series of five doses of Id-KLH by subcutaneous injection within a 24-week period. Granulocyte-macrophage colony-stimulating factor (GM-CSF) was also administered as an adjuvant in order to stimulate the immune system. Thirteen of the 16 patients (81%) demonstrated tumor-specific immune responses after receiving the five injections. The results were presented yesterday by John Timmerman, MD, Assistant Professor of Medicine at UCLA Medical Center.

"This study demonstrates for the first time that personalized idiotype vaccine treatment can elicit an anti-tumor response in patients with follicular non-Hodgkin's lymphoma who have advanced disease, but do not require immediate treatment with chemotherapy," said Dr. Timmerman.

GTOP-99 is an investigational agent developed by Genitope Corporation. A pivotal Phase 3 clinical study is currently being conducted at 25 institutions throughout the United States and Canada to further evaluate its safety and efficacy in patients with f-NHL in first remission following chemotherapy. Approximately 480 patients are expected to participate in the study. In Phase 2 studies, GTOP-99 has been well tolerated. Common side effects include mild to moderate pain, swelling and redness at the site of injections. Some patients experience fever, bone or joint pain and may have flu-like symptoms (nausea, headache and tiredness). These side effects generally last only for a few days after each injection.

"Given the promising clinical activity seen in Phase 2 studies using personalized idiotype vaccines, it is now reasonable to consider a therapeutic strategy for follicular lymphoma that places vaccine therapies forward in the initial therapeutic decision point. In this strategy, the therapeutic tumor vaccine is instituted in tandem with initial cyto-reductive chemotherapy," Timmerman added. "By recruiting the patient's own immune system to fight their cancer the first remission may be prolonged, thereby sparing patients from the unwanted side effects and toxicities associated with many other lymphoma therapies."

ABOUT GENITOPE

Genitope Corporation is a biotechnology company focused on the discovery and development of personalized immunotherapies for the treatment of cancer. The company's current programs focus on gaining an understanding of how to harness the immune system to provide safe and effective treatments. Genitope's proprietary manufacturing process which includes its Hi-GET(TM) technology, featuring high throughput gene expression techniques, is designed to rapidly and efficiently generate customized idiotype proteins that are being studied as potential cancer therapies. The company is currently conducting a pivotal Phase 3 clinical trial of GTOP-99 personalized immunotherapy in patients with follicular non-Hodgkin's lymphoma in first remission following chemotherapy. In addition to GTOP-99, Genitope is also developing product candidates for chronic lymphocytic leukemia (CLL) and T-Cell non-Hodgkin's lymphoma. For more information about our current clinical trials, please contact Genitope at (866) GENITOPE (436-4867) or visit www.genitope.com.