Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-CXCR4 Antibody, MDX-1338
-Clinical study planned for relapsed / refractory acute myelogenous leukemia-
PRINCETON, N.J., May 27 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX)
announced today the allowance of an investigational new drug application (IND) filed
with the U.S. Food & Drug Administration (FDA) for MDX-1338, for the treatment of
patients with acute myelogenous leukemia (AML). MDX-1338 is a fully human antibody that
targets CXCR4, a chemokine receptor found on the surface of many cancer cells,
including certain leukemias, lymphomas and other cancers. Preclinical laboratory experiments
have shown that MDX-1338 can block the growth of, and even directly kill, selected
human tumor cells.
The Phase 1, open-label, multicenter, dose-escalation study of MDX-1338 as a
monotherapy and in combination with chemotherapy is expected to enroll up to 34 patients
with relapsed/ refractory AML. This trial is designed to establish and evaluate the
safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics
and efficacy of MDX-1338.
"We are pleased that MDX-1338 has progressed into the clinic, representing our
eighth development candidate in oncology and further enhancing our focus on
oncology/immunology therapeutic indications," said Howard H. Pien, Chairman and CEO of Medarex.
"We believe that MDX-1338 could have potential activity in multiple cancers. Our first
Phase 1 study will be conducted in AML and future studies are expected to target a
variety of other leukemias and solid tumors and may involve monotherapy and combination
therapy."
The American Cancer Society estimates that in 2008, approximately 13,290
patients in the United States will be diagnosed with AML. |
