11 February 2013 | News | By BioSpectrum Bureau
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
Singapore: OxOnc Development, an oncology development company founded by pharmaceutical development executives and oncology experts, has entered into a co-development agreement with Pfizer to conduct a pivotal clinical trial of Pfizer's crizotinib, marketed under the trademark Xalkori, 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 US, EU, Japan and other countries.
OxOnc partners have extensive experience in building and managing oncology research networks in Europe and Asia and in managing global contract research organizations to optimally design and execute clinical trials.
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.
"We are extremely pleased to collaborate with Pfizer and to support further clinical development of Xalkori in NSCLC patents. It is gratifying to be involved in co-developing this innovative targeted therapy which exemplifies the future of oncology drug development," said Dr Wenn Sun, managing partner, OxOnc.
"Pfizer continues to establish innovative partnerships that extend the scale and scope of our oncology clinical development program," said Mr Garry Nicholson, president and general manager, Pfizer Oncology. "Xalkori is a breakthrough medicine in our oncology portfolio which may hold potential for patients with ROS1-positive advanced NSCLC. Through our collaboration with OxOnc, we hope to explore the potential benefit that this important therapy may bring to this subset of lung cancer patients who are in need of additional treatment options."