Monday, February 11, 2013

OxOnc Development to partner Pfizer for the development of its NSCLC drug Xalkori in specific NSCLC patients in China

OxOnc Development LP announced that it has entered into a co-development agreement with Pfizer Inc., to conduct a pivotal clinical trial of Pfizer's crizotinib, marketed under the trademark Xalkori(R), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring a ROS1 (c-ros) gene
rearrangement (ROS1-positive). ROS1 is a receptor tyrosine kinase of the insulin receptor family. The trial will be conducted at multiple sites in Japan, China, Taiwan and South Korea to assess the safety and efficacy of crizotinib in patients with ROS1-positive advanced NSCLC. Crizotinib is approved for the treatment of patients with ALK-positive advanced NSCLC in the U.S., EU, Japan and other countries. Under the terms of the agreement, OxOnc will provide funding and supervision for the trial, with the goal of generating the clinical data necessary for Pfizer to submit crizotinib for review by regulatory authorities for the treatment of advanced ROS1-positive NSCLC in the Asian region. If approved for this indication, OxOnc will be eligible to receive milestone payments from Pfizer. Additional terms were not disclosed.