NANJING, China, Sept. 3 /PRNewswire-FirstCall/ -- Simcere Pharmaceutical Group , a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endu (also known as Endostar) in China, announced the interim results of Endu Phase IV clinical study.
At the request of the SFDA, Simcere initiated a Phase IV clinical study to further validate the safety and therapeutic efficacy of Endu, a modified version of recombinant human endostatin, in combination with platinum-based chemotherapy, on large samples of patients in advanced stages of non-small cell lung cancer (NSCLC). The primary endpoint of this study was to evaluate the safety and therapeutic efficacy of Endu in conjunction with platinum-based chemotherapy. It is designed as an open label, prospective, and multi-center Phase IV study, which for the interim results, included 648 patients at the advanced stages of NSCLC. This study is led by the center of Good Clinical Practice (GCP) of Cancer Hospital of Chinese Academy of Medical Sciences.
Highlights of the interim results of Endu Phase IV clinical study:
-- Endu plus platinum-based chemotherapy produces synergistic activity against advanced NSCLC;
-- The Endu-platinum chemotherapy regime was well tolerated, and therapeutic efficacy was in accordance with that of the Phase III study;
-- The overall response rate and clinical benefit rate were 24.13% and 81.22% respectively. The response rates of the newly treated and previously treated groups were 30.88% and 17.34%(P<0.05), corresponding to CBP 86.03% and 76.38%(P<0.05) respectively.
Professor Sun Yan, Member of Chinese Academy of Engineering, said: "The interim results of the open-label, large sample, multi-center Endu phase IV clinical study affirms the safety and therapeutic efficacy of Endu acting in conjunction with platinum-based chemotherapy. With our continued research of Endu Phase IV, we will collect more clinical data to further evaluate the safety and efficacy of Endu."
To date, over 2,000 NSCLC patients have been recruited for Endu Phase IV clinical study. The final results of the study will be announced in the first half of 2010.
As a leading patented anti-cancer biotech product in China, Endu 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.
About Simcere Pharmaceutical Group
Simcere Pharmaceutical Group is a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endu in the rapidly growing China market. In recent years, Simcere has been focusing its strategy on the development of first-to-market generic and innovative pharmaceuticals, and has introduced a first-to-market generic stroke management medication under the brand name Bicun and an innovative anti-cancer medication under the brand name Endu. Simcere currently manufactures and sells more than 50 pharmaceutical products including antibiotics, anti-cancer medication and stroke management medication and is the exclusive distributor of three additional pharmaceuticals that are marketed under its brand names. Simcere concentrates its research and development efforts on the treatment of diseases with high incidence and/or mortality rates and for which there is a clear demand for more effective pharmacotherapy such as cancer, strokes, osteoporosis and infectious diseases and currently has more than 12 pipeline products. For more information about Simcere Pharmaceutical Group, please visit www.simcere.com.
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