Chinese company Simcere Pharmaceutical announced that it has successfully completed Endostar phase IV clinical study at a conference in Beijing dedicated to this study. The New Drug Research Institute of Cancer Hospital, the Chinese Academy of Medical Science and the Chinese Society of Clinical Oncology (CSCO) hosted the event.
Endostar is approved as a class-1 drug by the State Food and Drug Administration (SFDA) for the treatment of cancer. Since September 2005, the Chinese government has licensed Endostar to treat non-small-cell lung cancer (NSCLC). Endostar is a modified version of recombinant human Endostatin designed to stop the growth of cancer by starving it of oxygen and other nutrients. According to the company, it is the first anti-angiogenic drug successfully launched in the world and is regarded among the healthcare community as a key milestone in the development of anti-cancer treatment.
Endostar is recommended in the National Comprehensive Cancer Network of China Clinical Practice Guidelines in Oncology Chinese as a first line treatment for NSCLC.
Following changes in the Provisions for Drug Registration in China in 2005, Simcere invited Prof Sun Yan from the Department of Medical Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences as Principal investigator, and the other 153 famous medical centers, to conduct a phase IV clinical study for Endostar to further evaluate the safety and efficacy of this innovative new drug. The study was designed as an open label, prospective, and multi-center study and was the first phase IV clinical study for a class-1 new drug in china. The findings of Endostar phase IV clinical study verified that Endostar phase III and IV are comparable and by combining Endostar with standard chemotherapy regimens, this could improve the median survival time and overall survival rate of patients with advanced NSCLC with no significant increase of the adverse effects of chemotherapy.