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At the request of the SFDA, Simcere initiated a Phase IV clinical study tofurther validate the safety and therapeutic efficacy of Endu, a modifiedversion of recombinant human endostatin, in combination with platinum-basedchemotherapy, on large samples of patients in advanced stages of non-smallcell lung cancer (NSCLC). The primary endpoint of this study was to evaluatethe safety and therapeutic efficacy of Endu in conjunction with platinum-basedchemotherapy. It is designed as an open label, prospective, and multi-centerPhase IV study, which for the interim results, included 648 patients at theadvanced stages of NSCLC. This study is led by the center of Good ClinicalPractice (GCP) of Cancer Hospital of Chinese Academy of Medical Sciences.
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Highlights of the interim results of Endu Phase IV clinical study:
-- Endu plus platinum-based chemotherapy produces synergistic activityagainst advanced NSCLC;
-- The Endu-platinum chemotherapy regime was well tolerated, andtherapeutic efficacy was in accordance with that of the Phase III study;
-- The overall response rate and clinical benefit rate were 24.13% and81.22% respectively. The response rates of the newly treated and previouslytreated groups were 30.88% and 17.34%(P<0.05), corresponding to CBP 86.03% and76.38%(P<0.05) respectively.
Professor Sun Yan, Member of Chinese Academy of Engineering, said: "Theinterim results of the open-label, large sample, multi-center Endu phase IVclinical study affirms the safety and therapeutic efficacy of Endu acting inconjunction with platinum-based chemotherapy. With our continued research ofEndu Phase IV, we will collect more clinical data to further evaluate thesafety and efficacy of Endu."
To date, over 2,000 NSCLC patients have been recruited for Endu Phase IVclinical study. The final results of the study will be announced in the firsthalf of 2010.
As a leading patented anti-cancer biotech product in China, Endu isrecommended in the National Comprehensive Cancer Network of China ClinicalPractice Guidelines in Oncology Chinese Version (2006-2008)as a first linetreatment for NSCLC.
About Simcere Pharmaceutical Group
Simcere Pharmaceutical Group (NYSE: SCR, Simcere) is a leadingmanufacturer and supplier of branded generic pharmaceuticals and manufacturerof the patented anti-cancer biotech product Endu in the rapidly growing Chinamarket. In recent years, Simcere has been focusing its strategy on thedevelopment of first-to-market generic and innovative pharmaceuticals, and hasintroduced a first-to-market generic stroke management medication under thebrand name Bicun and an innovative anti-cancer medication under the brand nameEndu. Simcere currently manufactures and sells more than 50 pharmaceuticalproducts including antibiotics, anti-cancer medication and stroke managementmedication and is the exclusive distributor of three additionalpharmaceuticals that are marketed under its brand names. Simcere concentratesits research and development efforts on the treatment of diseases with highincidence and/or mortality rates and for which there is a clear demand formore effective pharmacotherapy such as cancer, strokes, osteoporosis andinfectious diseases and currently has more than 12 pipeline products. For moreinformation about Simcere Pharmaceutical Group, please visit www.simcere.com.Investor and Media Contact: Email: [email protected] In Nanjing: Frank Zhao Chief Financial Officer Simcere Pharmaceutical Group Tel: 86-25-8556-6666 ext 8818 E-mail: [email protected] In the United States
