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Phase 2 Results of MDX-060 in Hodgkin’s Disease Looks Promising
PRINCETON, N.J., June 9 /PRNewswire-FirstCall/ -- Medarex, Inc. today announced that in a Phase II clinical trial, 18 percent of patients, or three of 17, with refractory Hodgkin's disease (HD) experienced ongoing complete or partial responses with durations of at least three months when treated with 15 mg/kg of Medarex's MDX-060 antibody. One patient experienced a complete response of over three months' duration, and two patients experienced ongoing partial responses of over three months' and four months' duration, respectively. All three patients experiencing a complete or partial response in the Phase II clinical study had failed at least two prior therapies, which included chemotherapy, radiation treatment, immunotherapy and/or autologous stem cell transplant.
The Phase II clinical study consisted of expanded cohorts at the two highest doses of an earlier Phase I multi-dose study and was conducted in 27 patients with refractory HD, anaplastic large cell lymphoma (ALCL) or other CD30-positive lymphomas. Eighty-five percent of patients treated in this study had received and failed prior therapies. Four weekly doses of the MDX-060 antibody were given to 10 patients in the 10.0 mg/kg dose group and to 17 patients in the 15.0 mg/kg dose group. No infusion reactions or serious drug- related adverse events were reported in the Phase II study.
"We are excited with the safety profile and with the results in patients responding to the MDX-060 treatment," said Donald L. Drakeman, President and CEO of Medarex. "We expect to continue the rapid development of MDX-060 as a potentially important new treatment option for refractory Hodgkin's disease."
MDX-060 is a fully human antibody that is believed to target CD30, a member of the tumor necrosis factor receptor superfamily and a molecule found on activated lymphocytes. CD30 has been found to be over-expressed in several lymphoproliferative disorders and is present on malignant cells of Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL), as well as other CD30- positive lymphomas. Of the nearly 500,000 Americans with lymphoma, 168,000 have HD. According to the American Cancer Society, in 2004 there will be approximately 7,880 new cases of Hodgkin's disease in the United States, and an estimated 1,320 people will die of the disease. The frequency of ALCL in the United States is not known, but worldwide, ALCL accounts for approximately 5% of all non-Hodgkin's lymphoma.
Results from an earlier Phase I/II MDX-060 clinical study were reported at the 2003 American Society of Hematology annual meeting. The 31 patients assessed in the Phase I/II study included the initial 10 patients that received 10.0 mg/kg of MDX-060 in the Phase II clinical study. Patients with relapsed or refractory HD, ALCL or other CD30-positive lymphomas (without curative options) received weekly doses of 0.1, 1.0, 5.0 or 10.0 mg/kg of MDX- 060 for four weeks. One complete response and two partial responses were observed in patients. In the Phase I/II study, MDX-060 was generally well- tolerated. No human anti-human antibody responses (HAHA) or significant infusion reactions.