Clavis discontinues development of elacytarabine
Clavis Pharma ASA (OSE:CLAVIS) discontinued development of elacytarabine after the compound missed the primary endpoint of improving median overall survival (OS) vs. investigator's choice of therapy in the Phase III CLAVELA trial to treat late-stage acute myelogenous leukemia (AML). The open-label, international trial enrolled 380 patients with relapsed or refractory AML. Clavis said it plans to review strategic options during the coming weeks and will take immediate steps to reduce costs. Elacytarabine is a Lipid Vector Technology (LVT) derivative of cytarabine (Ara-C).
Clavis said its remaining assets are in preclinical testing, including cancer compound CP-4200, an LVT derivative of azacitidine. Last November, Clavis and former partner Clovis Oncology Inc. (NASDAQ:CLVS) discontinued development of Clavis' CP-4126 ( CO-101) after data from the pivotal Phase II LEAP trial showed that IV CP-4126 missed the primary endpoint of improving OS for metastatic pancreatic cancer. The product is a lipid-conjugated form of gemcitabine (see BioCentury, Nov. 19, 2012). ...