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news.Tanox has filed an investigational new drug application with the FDA for TNX-650 for the treatment of Hodgkin's lymphoma that is refractory to chemotherapy or radiation treatment.
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The company’s initial clinical development of TNX-650 will focus on the agent’s use as 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.
TNX-650 is a monoclonal antibody targeting interleukin 13, an important growth factor for malignant lymphoma cells. In preclinical testing, TNX-650 inhibited the function of IL-13, blocking the proliferation of malignant cells. Patient enrollment in a phase I clinical trial of TNX-650 is scheduled to begin in the first half of 2006.
The current standard treatment of Hodgkin’s lymphoma, while providing a high overall cure rate, is associated with significant short- and long-term toxicities attributable to chemotherapy and/or radiation therapy.
If shown to be safe and effective, TNX-650 could provide advantages over conventional therapies. There are no approved drugs for the treatment of patients with relapsed or refractory Hodgkin’s lymphoma.