Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Medarex has got the approval from FDA for MDX-1338, an investigational new drug for the treatment of patients with acute myelogenous leukemia. MDX-1338, a fully human antibody that targets CXCR4, a chemokine receptor found on the surface of cancer cells, including certain leukemias, lymphomas and other cancers. Preclinical laboratory experiments have shown that MDX-1338 can block the growth of selected human tumor cells.
Subscribe to our email newsletter
The Phase 1, dose-escalation study of MDX-1338 as a monotherapy with chemotherapy is expected to enroll up to 34 patients with relapsed/ refractory AML.
Moreover, 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.
Howard H. Pien, Chairman and CEO of Medarex, said: 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,
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, he added.