GTOP selling off after this release:
>>ASH Abstract # 357:
SAN DIEGO, Dec. 8 /PRNewswire-FirstCall/ -- Genitope Corporation (Nasdaq: GTOP - News) today announced results of a Phase 2 clinical trial evaluating MyVax(TM) Personalized Immunotherapy for the treatment of aggressive non-Hodgkin's lymphoma, including mantle cell lymphoma (MCL). The data were presented at the American Society of Hematology's 45th Annual Meeting and Exposition on December 8, 2003 by John P. Leonard, M.D., Assistant Professor of Medicine at Weill Cornell Medical College of Cornell University, and Medical Director of Oncology Services at New York-Presbyterian Hospital/Weill Cornell Medical Center.
The study examined two dosing strategies of MyVax(TM) Personalized Immunotherapy. The data suggest an accelerated schedule with more doses of MyVax(TM) Personalized Immunotherapy may be a safe and effective treatment following chemotherapy in individuals with aggressive lymphoma, including mantle cell lymphoma.
"Patients with mantle cell lymphoma typically respond well to chemotherapy, but the disease has the shortest median survival of all lymphoma subtypes and generally recurs quickly," says Dr. Leonard. "This study is an important step in the right direction, as we need to find an effective treatment for this difficult disease."
The study involved 27 patients with aggressive non-Hodgkin's lymphoma, in complete or partial remission following CHOP chemotherapy. Each patient received one of two treatment schedules of MyVax(TM) Personalized Immunotherapy. Fourteen patients on Schedule A (five with MCL) received five immunizations over 24 weeks, starting three months after completing chemotherapy. The median time to disease progression for the mantle cell patients on Schedule A was 254 days following completion of chemotherapy. In an attempt to improve clinical responses, an accelerated and extended administration regimen was developed. Thirteen patients on Schedule B (11 with MCL) began receiving MyVax(TM) Personalized Immunotherapy three months following completion of chemotherapy. Patients were immunized with MyVax(TM) Personalized Immunotherapy every two weeks for seven doses, with an eighth dose administered at week 18. In the MCL population on Schedule B, the median time to disease progression was 477 days following completion of chemotherapy.
"There is no clearly curative therapy for mantle cell lymphoma, and it is a particularly challenging lymphoma to treat. Though the number of patients in the study is limited, we are encouraged that patients treated with the accelerated schedule of MyVax(TM) Personalized Immunotherapy may have more extended remissions than otherwise expected with this disease," commented Dr. Leonard. "We continue to watch these patients closely and hope to further evaluate the potential benefit of this treatment for mantle cell and other aggressive lymphomas."
Mantle cell lymphoma is a B-cell non-Hodgkin's lymphoma. Mantle cell lymphoma accounts for about six percent of all non-Hodgkin's lymphoma cases in the United States and primarily affects men over age 50.
MyVax(TM) Personalized Immunotherapy is a patient- and tumor-specific therapy based on the unique genetic makeup of a patient's own tumor. MyVax(TM) Personalized Immunotherapy consists of a patient-specific and tumor-specific cell surface idiotype protein (Id), combined with keyhole limpet hemocyanin (KLH), an immunogenic carrier protein. It is co-administered with granulocyte macrophage-colony stimulating factor (GM-CSF). MyVax(TM) Personalized Immunotherapy is currently being investigated in a pivotal, Phase 3 clinical trial at 34 leading North American oncology centers for the potential treatment of follicular non-Hodgkin's lymphoma.<<
Not sure if toxicity becomes an issue at the higher dose or what. A little curious that side effects are not even mentioned. But the results apparently didn't live up to someone's expectations.
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Cheers, Tuck |
