ARTICLE | Clinical News

CPX-351: Phase II started

September 8, 2014 7:00 AM UTC

Celator began an open-label, U.S. Phase II trial to evaluate CPX-351 in about 36 patients with acute hematologic malignancies, including acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). The trial will also include patients with moderate hepatic and renal impairment. Patients will receive a first induction of 100 units/m 2 CPX-351 on days 1, 3 and 5. In patients with reduced leukemia/MDS burden not yet achieving a leukemia/MDS free state, a second induction of 100 units/m 2 CPX-351 on days 1 and 3 will be given if necessary. The company said responding patients will be eligible for up to 4 consolidation courses. Top-line data are expected in 2H15. Celator said the study is designed to support an NDA, which the company plans to submit to FDA in 2H16. ...