HOUSTON, May 23 /PRNewswire-FirstCall/ -- Dosing has begun in the Phase 1 clinical trial of TNX-650, a monoclonal antibody from Tanox, Inc. for the treatment of Hodgkin's lymphoma in patients who are refractory to chemotherapy or radiation treatment.
The non-randomized, multiple-dose, dose-escalation trial is currently being conducted at M. D. Anderson Cancer Center in Houston, with additional patient enrollment expected later this year at Memorial Sloan-Kettering Cancer Center in New York City. Enrollment in the trial is expected to continue throughout 2006.
TNX-650 targets Interleukin 13, an important growth factor for malignant Hodgkin's lymphoma cells. In pre-clinical testing, TNX-650 inhibited the function of IL-13 and blocked the proliferation of malignant cells.
The objective of the Phase 1 trial is to determine the safety, tolerability and pharmacokinetics of the agent as a monotherapy in patients who have relapsed or are refractory to standard chemotherapy with or without radiation therapy, and who have not responded to or are unable to undergo autologous bone marrow transplantation. There are no approved drugs for the treatment of patients with relapsed or refractory Hodgkin's lymphoma.
Tanox expects to file an Investigational New Drug application for TNX-650 in an inflammatory-disease indication later this year.
About Hodgkin's lymphoma
Hodgkin's lymphoma (HL), also referred to as Hodgkin's disease, is a cancer of the lymph system. HL can affect lymph nodes, blood and lymph vessels, and bone marrow, as well as organs such as the spleen, thymus and tonsils. The disease often begins in a single lymph node and is characterized by growth of malignant cells in the lymph tissues that inhibit or suppress the formation and function of other cells in the lymph tissues. The challenge to treating HL is not just achieving a cure, but avoiding long-term toxicities that have been linked with secondary malignancies. Each year, nearly 8,000 patients in the U.S. are diagnosed with Hodgkin's disease. Approximately 25 percent of these patients do not respond to the current standard of care.
About Tanox, Inc.
Tanox is a biotechnology company specializing in the discovery and development of monoclonal antibodies. The company develops innovative biotherapeutics for the treatment of immune-mediated diseases, inflammation, infectious disease and cancer. Tanox's lead investigational therapy, TNX-355, is a viral-entry inhibitor antibody to treat HIV/AIDS. TNX-355 has shown significant antiviral activity in Phase 2 clinical testing. Tanox's first- approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. Xolair was developed in collaboration with Genentech, Inc. and Novartis Pharma AG and is approved for marketing in the United States, Canada and major European countries. Tanox is based in Houston and has a manufacturing facility in San Diego. Additional corporate information is available at http://www.tanox.com .
This news release contains forward-looking statements regarding the potential for TNX-650 as a treatment for Hodgkin's lymphoma (HL). These statements are based on Tanox's current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. The ability of Tanox to fully enroll the TNX-650 Phase 1 clinical trial could be delayed due to the institutional review board review process and the availability of qualified patients to participate in the trial. The timing of the filing of an investigational new drug application could be delayed due to various business issues, the FDA review process and lack of adequate clinical drug supply. The therapeutic potential of TNX-650 as a treatment for HL patients is subject to the risks inherent in drug development. Drug development involves a high degree of risk. Drugs may not show therapeutic effect or an acceptable safety profile in early stage clinical trials. Success in early stage clinical trials does not ensure that later stage or larger-scale clinical trials will be successful. The results achieved in later-stage trials may not be sufficient to meet applicable regulatory standards. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing drugs. For more detailed information on the risks and uncertainties associated with Tanox's drug development and other activities, see Tanox's periodic reports filed with the Securities and Exchange Commission.
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