Simcere Pharmaceutical Group (NYSE: SCR), a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endostar (also known as Endu) in China, announced today the successful completion of 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 (license no. S20050074). 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. 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 (Version 2006-2008) 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.
Endostar Phase IV clinical study passed the IRB/EC committee board of the Chinese Academy of Medical Science on November 10, 2006 and has taken two and half years to complete. Enrolment of the first patients commenced December 20, 2006, and the last patient was enrolled on June 10, 2009. In total, 2725 subjects were enrolled, which is the largest clinical study ever conducted in China. The survival analysis for stage statistics showed that Mean Survival Time (MST) was 17.57 months, 1-year survival rate was 63.68%, 2-year survival rate was 39.79%, and median Time to Tumor Progression (TTP) was 7.37 months. Objective Response Rate (ORR) was 23.93%, and Disease Control Rate (DCR) was 76.07%.
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.
At the conference, some investigators (such as medical centers in Sichuan and Zhejiang) reported that Endostar was found also significantly effective for the treatment of pleural/ascetic fluid and Gliomas (a type of brain tumor). Currently, there are many on-going clinical studies of Endostar including lung cancer and non-lung cancer (e.g.: Osteosarcoma and Colorectal cancer). Most of them have registered in the http://clinicaltrials.gov , the registry of US National Institutes of Health.
With the successful completion of Endostar's Phase IV clinical study, as required by the new national drug registration law, Endostar is expected to be the first new drug to successfully pass re-registration.
Professor Sun Yan, Member of the Chinese Academy of Engineering, commented at today's conference: "This Phase IV clinical study is the first of its kind to be completed in China and houses a huge amount of data which we can tap into to help patients suffering from advanced stages of Non-Small-Cell Lung Cancer. These are very encouraging results and with its re-registration, Endostar will bring relief to patients across China for many years to come."
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