MILLENNIUM INITIATES PHASE I/II TRIAL OF MLN518

Millennium Pharmaceuticals has begun a Phase I/II, open-label, multicenter study of MLN518 in combination with standard induction chemotherapy in patients with newly diagnosed acute myelogenous leukemia (AML). The trial will also assess MLN518 as a single-agent in remission maintenance therapy.

This study will evaluate the safety, tolerability and initial response rates of MLN518 in combination with cytarabine and daunorubicin, the standard induction chemotherapy in front-line AML. Previous results from a single-agent Phase I/II study of MLN518, presented at the annual meeting of the American Society of Hematology 2004, established a well-tolerated dose along with strong preliminary antileukemic activity.

MLN518 is a novel, oral, small molecule designed to inhibit Type III receptor tyrosine kinases, including FLT3, PDGFR and c-KIT. Tyrosine kinases are enzymes involved in several cellular processes and are known to be activated in cancer cells to drive tumor growth. AML patients with FLT3 mutations experience earlier disease relapse and shorter survival rates compared to patients without these mutations. Approximately 25 to 30 percent of all adult AML patients have a mutation of the FLT3 gene.