Medarex Announces Filing of Investigational New Drug Application for MDX-060
Fully Human Antibody Candidate for CD30 Positive Lymphomas
PRINCETON, N.J., May 29 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced the filing of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate Phase 1 clinical trials of MDX-060, a fully human antibody product candidate for Hodgkin's disease, Anaplastic Large Cell Lymphoma and other CD30 positive lymphomas.
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 disease and Anaplastic Large Cell Lymphoma, as well as other lymphomas and cancers. There are nearly 100,000 cases of Hodgkin's disease and Anaplastic Large Cell Lymphoma worldwide. Pre-clinical studies suggest that the MDX-060 antibody may induce tumor regression through direct inhibition of cellular proliferation or through the recruitment of immune effector cells.
"We believe that CD30 is a critical molecule for these lymphomas, just as CD20 is critical for some B cell lymphomas. Preclinical data suggests that MDX-060 may block that critical function and potentially affect the disease. We are eager to see how MDX-060 performs in the clinic," said Thomas A. Davis, M.D., Senior Director of Clinical Science at Medarex.
"Monoclonal antibody-based therapeutics have become very important in the treatment of lymphomas, and we believe that MDX-060 has the potential to be a significant therapeutic product for these life-threatening diseases," said Donald L. Drakeman, President and CEO of Medarex. |
