ATLANTA, Dec. 12 /PRNewswire-FirstCall/ -- Long-term follow-up results from a phase II clinical trial of Genitope Corporation’s (Nasdaq: GTOP - News) MyVax® Personalized Immunotherapy as a treatment for follicular Non- Hodgkin’s Lymphoma (f-NHL) after chemotherapy shows a significant increase in time-to-progression of f-NHL compared to chemotherapy alone. Study findings were presented during a poster session at the 47th Annual Meeting of the American Society of Hematology in Atlanta.
The long-term follow-up data (median 5.8 years) demonstrated a median time-to-disease-progression of 37.7 months (measured from the end of chemotherapy). Published studies in similar follicular B-cell NHL patients treated with chemotherapy alone have shown a median time-to-disease- progression of 15 months. Nine of the 21 patients in this trial remained progression-free as of their last clinical follow-up at 56 to 78 months post- chemotherapy. Furthermore, 19 of the 21 evaluated patients scored in the intermediate or high-risk prognostic categories according to the Follicular Lymphoma International Prognostic Index (FLIPI). Four of the eight patients in the high-risk category and four of the 11 patients in the intermediate category remained in remission as of their last clinical follow-up.
“These results suggest that MyVax® Personalized Immunotherapy may be altering the natural history of the disease for nearly half the patients treated by inducing long-term remissions, even in patients anticipated to have poorer prognoses based on their FLIPI score, a commonly used prognostic index,” said Dr. John Timmerman, one of the principal investigators for the clinical trial and assistant professor, UCLA Medical Center. “Further, there were a number of patients who had residual tumor observed on CT scans following chemotherapy that converted to a complete response following their immunizations with MyVax® Personalized Immunotherapy.”
In this open-label, phase II clinical trial -- conducted at Stanford University Medical Center in California and the University of Nebraska Medical Center -- patients with follicular B-cell NHL in first remission following a four- to seven-month regimen of either CVP chemotherapy (16 patients) or CVP + CHOP chemotherapy(1) (five patients) received a series of five immunizations of MyVax® Personalized Immunotherapy over a period of six months.
“The results of our phase II trial appear to replicate those found in an earlier idiotype-based vaccine trial started at Stanford University Medical Center in 1988 and further validate that it may be possible to significantly prolong remissions in patients suffering from f-NHL with MyVax® Personalized Immunotherapy,” said Dan W. Denney, Jr., Ph.D, chairman and CEO of Genitope. “The presentation of this data represents an important milestone for Genitope as we advance the development of personalized immunotherapy.”
Genitope is currently conducting a pivotal, double-blind, controlled, phase III clinical trial evaluating the safety and efficacy of MyVax® Personalized Immunotherapy in previously untreated patients with f-NHL. In this clinical trial, patients first received chemotherapy to reduce their tumor burden, followed by a 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 the control for this trial. The phase III clinical trial is fully enrolled. In July 2005, Genitope’s independent Data Safety Monitoring Board met and reviewed the first planned interim analysis of data for efficacy and safety in this Phase 3 clinical trial and recommended that the trial continue as planned. Genitope has completed treatment of all 287 patients in this clinical trial and currently anticipates that the next planned interim analysis of data from this clinical trial for efficacy will occur in mid-2006. The detailed follow-up period of this clinical trial is scheduled to conclude in approximately the fourth quarter of 2007.
The poster (#642) is available for viewing beginning December 11, 2005 in Hall B-4 at the Georgia Convention Center.
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 efficacy of MyVax® Personalized Immunotherapy and the timing of the next interim analysis of data in Genitope Corporation’s ongoing Phase III clinical trial. 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® and other risks detailed in Genitope Corporation’s filings with the Securities and Exchange Commission, including the Quarterly Report for the fiscal quarter ended September 30, 2005. 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.
(1) Chemotherapy regimen containing cyclophosphamide, adriamycin,
vincristine, prednisone
Source: Genitope Corporation
