Simcere Pharmaceutical Group Announces Interim Results of Endu Phase IV Clin...( NANJING China Sept. 3 /- SimcereP...),Health

NANJING, China, Sept. 3 /PRNewswire-FirstCall/ -- Simcere Pharmaceutical Group (NYSE: SCR), 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
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