Genitope Corporation Presents New Data On Its Therapeutic Monoclonal Antibodies To Potentially Treat B-Cell Malignancies
"The proof-of-concept studies are important because they suggest that these antibodies have a significant likelihood of working in the clinic," said Dan W. Denney, Jr., Ph.D., chief executive officer of Genitope. "We see an opportunity to combine the monoclonal antibody panel with our active personalized immunotherapy approach. By doing so, we have the potential to bring safer, effective medicines to non-Hodgkin's lymphoma patients."
Results for both studies showed that the number of target B-cells bound by the studied monoclonal antibodies decreased in treated animals, while no significant change was detectable in control animals. In one study, six animals received eight intravenous infusions of Genitope's monoclonal antibody; two naive control animals received infusions of placebo. In a second study evaluating a second monoclonal antibody from Genitope's panel, 12 animals received four intravenous infusions at various doses; two naive control animals received infusions of placebo.
Genitope has developed a panel of monoclonal antibodies that bind to different, variable regions expressed on B-cells. Because there are a finite number of variable-region genes that B-cells draw on, it is possible to classify patients with NHL into subsets based on which variable region is used by their particular tumor. In Genitope's planned clinical use, once a tumor is biopsied, a simple screening test would be performed to determine which regions are being used by the tumor and identify the group to which the patient belongs. Armed with these results, healthcare professionals could determine which monoclonal antibody from Genitope's panel would be most effective to target these applicable variable regions. This process allows for the production of monoclonal antibodies that are off-the-shelf while still personalizing the treatment for each patient.
Genitope is also developing its primary product candidate, MyVax(R) personalized immunotherapy, which is currently in a pivotal, blinded, controlled Phase 3 clinical trial to evaluate its safety and efficacy in previously untreated patients with follicular non-Hodgkin's lymphoma (fNHL). The treatment phase of this clinical trial has been completed and the protocol-defined follow-up period is scheduled to conclude by the end of this year.
Genitope recently announced the initiation of a Phase 2 clinical trial evaluating the use of MyVax(R) personalized immunotherapy following primary treatment with rituximab and chemotherapy (R-Chemo) in fNHL patients. Additionally, MyVax(R) personalized immunotherapy is being evaluated in a Phase 2 clinical trial for the treatment of patients with Chronic Lymphocytic Leukemia (CLL).
About Genitope Corporation
Genitope Corporation (Fremont, Calif.) is a biologics company focused on the research and development of novel immunotherapies for the treatment of cancer. Genitope Corporation's lead product candidate, MyVax(R) 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 to be forward-looking statements, including but not limited to statements about the potential benefits and applications of our monoclonal antibodies, the timing of the release of the final results of the Phase 3 trial for MyVax(R) personalized immunotherapy, the potential for commercialization of MyVax(R) personalized immunotherapy or its other programs and the continued development of our monoclonal antibody program. 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, difficulties or delays in obtaining regulatory approval, unanticipated expenditures or liabilities, the adequacy of our existing financial resources to support operations, competition from other pharmaceutical or biotechnology companies, the risks of growth and dependence on key personnel, risks relating to the manufacturing of MyVax(R) personalized immunotherapy, intellectual property matters, and other risks detailed in Genitope Corporation's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter year ended September 30, 2007. 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.
John Vuko, Chief Financial Officer, 650-482-2000
Marites Cristobal, 323-202-1424
Posted: December 2007