Phase III clinical failure - Sanofi drug against lung cancer

July 3, 2013, Sanofi (Sanofi) announced iniparib drug against experimental lung cancer and the first type of clinical factor Xa intravenous anticoagulant Otamixaban Phase III, and announced the completion of these two projects in clinical development drugs.

Iniparib:

For the ECLIPSE study iniparib randomized Phase III newly diagnosed squamous non-small cell lung cancer (squamous non-small cell lung cancer Sq NSCLC) patients for the trial in combination with chemotherapy for cancer patients iniparib were treated with chemotherapy alone phase relationship, iniparib and chemotherapy does not improve overall survival (OS), the attempt failed to meet the primary endpoint of the study.

More patients in connection with platinum-resistant ovarian cancer iniparib a set of clinical phase II data, and can not help in this patient group iniparib further development.

Based on these results, Sanofi decided to leave the program iniparib internal development.

Otamixaban (Otamixaban)

Otamixaban is an experimental, fast, direct injection selective inhibitor of coagulation factor Xa. Factor Xa in vivo coagulation cascade is a major part Otamixaban is the first type of factor Xa anticoagulant intravenously. A phase III study (TAO) data show that made the study of the study, the primary endpoint was not met. Search TAO non-acute coronary syndrome (non-ST elevation acute coronary syndromes, NSTE-ACS segment) to perform patient because lower than expected Otamixaban show respect to unfractionated heparin efficiency-ST-segment ( UFH) + / - eptifibatide (eptifibatide, an inhibitor such GP IIb / IIIa) in the benefit / risk ratio (risk / benefit) combined superiority. CAT primary endpoint of the study was to reduce mortality (all-cause mortality), a new myocardial infarction (heart attack).

TAO research based on data Sanofi decided to end development projects Otamixaban.