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news.Medarex has reported that two separate investigational new drug applications for MDX-1342, one for the treatment of chronic lymphocytic leukemia and the other for rheumatoid arthritis have received FDA allowance.
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The IND for the treatment of CLL is for an open-label, multi-dose, dose-escalation Phase I clinical trial for cancer that is expected to enroll up to 52 patients with relapsed or refractory CLL. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics and efficacy of MDX-1342.
The IND for the treatment of rheumatoid arthritis is for a randomized, single-dose, dose-escalation, placebo-controlled Phase I clinical trial that is expected to enroll up to 90 patients with rheumatoid arthritis. This trial is designed to evaluate the safety and tolerability profile of MDX-1342 and to determine the dose range for B-cell depletion.
MDX-1342 is a fully human antibody that targets CD19, a molecule specifically expressed on normal B-cells and malignant B-cells in diseases such as CLL, acute lymphoblastic leukemia, follicular non-Hodgkins lymphoma, diffuse large B-cell lymphoma and mantle cell lymphoma.
Howard Pien, president and CEO of Medarex, said: “We look forward to the continued development of MDX-1342, which could provide new treatment options for a number of serious conditions.”