http://www.tradingmarkets.com/news/stock-alert/scr_simcere-pharmaceutical-group-completes-phase-iv-cancer-study-866069.html

Mar 23, 2010 (Datamonitor via COMTEX) --

Simcere Pharmaceutical Group, a manufacturer and supplier of branded generic pharmaceuticals, has successfully completed Endostar Phase IV clinical study.

According to Simcere, Endostar is approved as a class-1 drug by the State Food and Drug Administration for the treatment of cancer.

Simcere invited 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 institutional review board/ ethics committee board of the Chinese Academy of Medical Science on November 10, 2006 and has taken two and half years to complete. Enrollment of the first patients commenced December 20, 2006, and the last patient was enrolled on June 10, 2009. In total, 2,725 subjects were enrolled.

The survival analysis for stage statistics showed that mean survival time was 17.57 months, one-year survival rate was 63.68%, two-year survival rate was 39.79%, and median time to tumor progression was 7.37 months. Objective response rate was 23.93%, and disease control rate 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.

Mr Yan said: "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 NSCLC. 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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