Healthcare Industry News: rituximab
News Release - May 21, 2007
Genitope Corporation Initiates Clinical Trial to Evaluate Use of MyVax(R) Personalized Immunotherapy Following Treatment With Rituximab and Chemotherapy for Follicular Non-Hodgkin's LymphomaFREMONT, Calif., May 21 (HSMN NewsFeed) -- Genitope Corporation (Nasdaq: GTOP ) today announced the initiation of a Phase 2 clinical trial evaluating the use of MyVax® personalized immunotherapy following primary treatment with rituximab and chemotherapy (R-Chemo) for follicular non-Hodgkin's lymphoma (fNHL). MyVax® personalized immunotherapy is based on the unique genetic makeup of a patient's own tumor and is designed to activate the patient's immune system to fight cancer.
"This is an important trial because it will provide additional information on the optimal timing for use of MyVax® personalized immunotherapy following treatment with the current standard of care for patients with fNHL," said Julie Vose, M.D., professor of medicine and chief of the Oncology/Hematology section, University of Nebraska Medical Center. "Initial data have suggested that adding MyVax® personalized immunotherapy to the current treatment protocol may extend duration of remission while maintaining a well-tolerated safety profile. We are optimistic this therapy will provide another promising option for the treatment of non-Hodgkin's lymphoma."
Genitope plans to enroll 100 patients in this multi-center, Phase 2, single-arm study at eight leading cancer centers across the United States, including the University of Nebraska Medical Center. The clinical trial is primarily designed to evaluate the efficacy and safety of MyVax® personalized immunotherapy following treatment with R-Chemo. Men and women ages 18 years or older who have been diagnosed with previously untreated fNHL, stage III or IV, and who require therapy and are able to receive rituximab and chemotherapy (cyclosphosphamide, vincristine and prednisone either with or without doxorubicin) may be eligible for the study. Eligible patients will receive six to eight cycles of R-Chemo, and after a six-month rest period, will receive a series of 24 immunizations with MyVax® personalized immunotherapy over a 92-week period.
"We continue to explore the optimal regimen for MyVax® personalized immunotherapy to induce a strong anti-tumor immune response in patients with fNHL," said Mary Ellen Rybak, M.D., vice president of Medical Affairs and chief medical officer at Genitope Corporation. "We hope that data from this Phase 2 trial will provide additional insight on the potential for MyVax® personalized immunotherapy to improve survival and alter the natural history of this disease."
For more information about the trial and a complete list of open trial sites, individuals can call Genitope Corporation at 866-GENITOP or visit the company's Web site at www.genitope.com.
MyVax® personalized immunotherapy is currently in a pivotal, double-blind, controlled Phase 3 clinical trial to evaluate its safety and efficacy in previously untreated patients with fNHL. In this trial, patients first received chemotherapy to reduce their tumor burden, followed by a 6-month rest period. Patients who maintained at least a partial response through the rest period were then randomized to receive either MyVax® personalized immunotherapy or a non-specific immunotherapy, which serves as a control for this trial. Genitope Corporation enrolled 287 patients in this Phase 3 trial. The treatment phase is completed and the protocol-defined follow-up period of the clinical trial is scheduled to conclude at the end of 2007.
NHL is the most common cancer involving B-cells, and is the sixth most common cancer in the United States. There are currently more than 300,000 people in the country living with NHL, with 55,000 new cases diagnosed annually and approximately 32 percent of those diagnoses being new fNHL cases. In addition to clinical trials in fNHL, Genitope Corporation is also exploring the use of MyVax® personalized immunotherapy to treat other types of B-cell cancers, including patients with previously untreated chronic lymphocytic leukemia.
About Genitope Corporation
Genitope Corporation (Redwood City, Calif.) is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Genitope Corporation's lead product candidate, MyVax® personalized immunotherapy, is a patient-specific active immunotherapy based on the unique genetic makeup of a patient's tumor and is designed to activate the patient's immune system to identify and attack cancer cells. For more information on the company, please log on to www.genitope.com.
Forward Looking Statements
This news release contains "forward-looking statements." For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements, including statements regarding the potential of MyVax® personalized immunotherapy to extend the duration of remission, improve survival or alter the natural history of follicular non-Hodgkin's lymphoma. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Genitope Corporation's results to differ materially from those indicated by these forward-looking statements, including without limitation, risks related to the progress, timing and results of Genitope Corporation's clinical trials, risks related to competition from other pharmaceutical or biotechnology companies, the risks of growth and dependence on key personnel, risks relating to the manufacturing of MyVax® personalized immunotherapy and other risks detailed in Genitope Corporation's filings with the Securities and Exchange Commission, including the Annual Report or Form 10-K for the fiscal year ended December 31, 2006. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genitope Corporation undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
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