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Julie Vose, M.D. |
Phase 2 of this trial will test the efficacy and safety of the therapy — called MyVax® personalized immunotherapy — following primary treatment with rituximab and chemotherapy (R-Chemo) for fNHL.
MyVax® 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 at UNMC. “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.”
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 UNMC.
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 also is 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 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 also is exploring the use of MyVax® personalized immunotherapy to treat other types of B-cell cancers, including patients with previously untreated chronic lymphocytic leukemia.