Medarex Announces MDX-060 Presentation at the American Society of Hematology Meeting
Wednesday November 5, 6:13 am ET
Abstract Scheduled to Be Published in Upcoming Issue of BLOOD
PRINCETON, N.J., Nov. 5 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) announced today that preliminary clinical activity data, including one complete response lasting four months, from a "Phase I/II study of a fully human anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL)" (Abstract #632) is scheduled to be included in an oral presentation in the New Agents session at the 45th Annual Meeting of the American Society of Hematology (ASH). Further data will be presented by Stephen M. Ansell, M.D., Ph.D., of the Division of Hematology, Mayo Clinic, during the ASH meeting, December 5-9, 2003, in San Diego, CA.
In the Phase I/II clinical study, 21 patients with relapsed or refractory HD, ALCL or other CD30-positive lymphomas (without curative options) are reported to have been treated with Medarex's fully human MDX-060 antibody. In the Phase I portion of the trial, which has been completely enrolled, patient cohorts of three to six patients received weekly doses of 0.1, 1.0, 5.0 or 10.0 mg/kg of MDX-060 for 4 weeks. In the Phase II portion of the trial, which continues to accrue patients, expanded cohorts are expected to receive MDX-060 at 10.0 or 15.0 mg/kg.
While efficacy assessments have not yet been completed in all patients, one patient with ALCL in the 1.0 mg/kg cohort group experienced a complete response to therapy of four months duration. One episode of possible drug-related toxicity occurred in the 1.0 mg/kg cohort group. The patient, who had a history of Graft versus Host Disease, developed elevated (Grade 3) liver transaminase levels. No significant infusion-related reactions and no opportunistic infections have occurred. No maximum tolerated dose has been identified. The abstract is available on the ASH website at www.hematology.org and also is scheduled to be published in an upcoming issue of BLOOD, the journal of the American Society of Hematology.
About MDX-060
MDX-060 is a fully human antibody that targets 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. |
