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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (772)	12/9/2003 6:14:42 AM
From: Icebrg	Read Replies (1) \| Respond to of 2240

Medarex Announces Complete and Partial Responses Observed in Phase I/II Clinical Study of MDX-060 at ASH Meeting Tuesday December 9, 6:00 am ET Phase II Clinical Study Ongoing PRINCETON, N.J., Dec. 9 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today that its fully human antibody, MDX-060, demonstrated clinical activity, including one complete response and two partial responses, in a Phase I/II clinical study in patients with Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL). In addition, stable disease was observed in nine of the 29 evaluable patients. The study was conducted in collaboration with Stephen M. Ansell, M.D., Ph.D., of the Division of Hematology, Mayo Clinic, as well as five other lymphoma experts. The data were presented by Dr. Ansell at the 45th Annual Meeting of the American Society of Hematology (ASH), December 5-9, 2003, in San Diego, CA (Abstract #632). In the Phase I/II clinical study, 31 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. All patients had failed multiple prior treatments and most had failed bone marrow transplantation. Tumor assessment data is not yet available for two patients. Of the 29 patients evaluated to date, one patient with ALCL in the 1.0 mg/kg cohort group experienced a complete response to therapy of four months duration. This patient has experienced a second complete response following re-treatment with MDX-060. Partial responses were experienced by two patients with Hodgkin's disease, one in the 5.0 mg/kg cohort with an ongoing response at four months and one in the 10.0 mg/kg cohort of three months duration. Of the nine patients experiencing stable disease, seven were in the 10.0 mg/kg cohort. Two episodes of possible drug-related adverse events were reported in the study. One patient in the 1.0 mg/kg cohort group with a history of Graft versus Host Disease developed elevated (Grade 3) liver transaminase levels which resolved after treatment with steroids. Elevated liver transaminase levels (Grade 2) were also observed in one patient in the 0.1 mg/kg cohort. No maximum tolerated dose has been identified. Enrollment of approximately 30 patients is ongoing in the Phase II portion of the trial to further explore the safety and activity profile of MDX-060. "We are excited that in a population of patients with extensive disease who have failed all other available lymphoma treatments, including bone marrow transplantation, MDX-060 has brought about complete and partial responses as well as stable disease," said Donald L. Drakeman, President and CEO of Medarex. "We believe that MDX-060 may provide an important new treatment option for patients with Hodgkin's disease or ALCL." About MDX-060 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 lymphoma and anaplastic large cell lymphoma (ALCL), as well as other CD30- positive lymphomas. According to the American Cancer Society, in 2003 there will be approximately 7,600 new cases of Hodgkin's disease in the United States, and an estimated 1,300 people will die of the disease. Worldwide, there are nearly 100,000 cases of Hodgkin's lymphoma and ALCL.