Medarex Inc. has filed an investigational new drug applicationfor its MDX-11, a monoclonal antibody-based treatment foracute myeloid leukemia (AML), the Princeton, N.J., companysaid Monday.
Medarex expects early in the year to begin Phase I/II clinicaltrials of the drug as an adjunct to chemotherapy. MDX-11 isintended to preclude relapses by targeting and destroyingresidual leukemia cells and their precursors.
Medarex (NASDAQ:MEDX) was granted orphan drug designationfor MDX-11 in 1991.
"MDX-11 will provide an in vivo therapeutic that we believewill be safe and effective, even for patients who are unable tohave a bone marrow transplant," said Donald Drakeman,president and chief executive officer.
MDX-11 also acts synergistically with another Medarexmonoclonal antibody product, now in early Phase II trials, thatis used to purify bone marrow used in autologous transplants,Drakeman told BioWorld.
Medarex shares ended Monday at $16.75, up 63 cents.-- KH
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