Navigation Links
Simcere Pharmaceutical Group Successfully Completes Endostar Phase IV Clinical Study
Date:3/22/2010

NANJING, China, March 22 /PRNewswire-Asia/ -- 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."

About Simcere Pharmaceutical Group

Simcere Pharmaceutical Group (SCR, Simcere) is a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endostar 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 Endostar. 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 http://www.simcere.com .

SOURCE Simcere Pharmaceutical Group

Back to top

RELATED LINKS
http://www.simcere.com
http://clinicaltrials.gov

'/>"/>

SOURCE Simcere Pharmaceutical Group
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Simcere Pharmaceutical Group to Announce Fourth Quarter and Fiscal Year 2009 Unaudited Financial Results on Tuesday, March 16, 2010
2. Simcere Receives SFDA Approval to Manufacture and Sell Zanamivir in China
3. Simcere Pharmaceutical Group Provides Update on Jiangsu Yanshen
4. Simcere Pharmaceutical Group Announces Jiangsu Yanshens Voluntary Suspension of Production
5. Simcere Pharmaceutical Group to Acquire Additional Stake in Jiangsu Yanshen Biological Technology Stock Co., Ltd.
6. Simcere Pharmaceutical Group Announces Collaboration with OSI Pharmaceuticals
7. Simcere Pharmaceutical Group Announces Interim Results of Endu Phase IV Clinical Study
8. Derycz Scientific Featured in Pharmaceutical Manufacturing and Genetic Engineering & Biotechnology News
9. Isis Pharmaceuticals to Present at the Barclays Capital 2010 Global Healthcare Conference
10. Amylin Pharmaceuticals to Present at The Barclays Capital 2010 Global Healthcare Conference
11. R&D Investment by U.S. Biopharmaceutical Companies Increases to Record $65.3 Billion, Study Finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/30/2016)... SAN FRANCISCO , May 30, 2016 /PRNewswire/ ...  is expected to reach USD 7.3 billion by ... View Research, Inc. The increasing natality rate, the ... conditions such as cancer and gastro-intestinal tract diseases ... forecast period.      (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ...
(Date:5/30/2016)... , May 30, 2016 ... H1 2016" market research report with comprehensive information ... with comparative analysis at various stages, therapeutics assessment ... of administration (RoA) and molecule type, along with ... It also reviews key players involved in the ...
(Date:5/27/2016)... 27, 2016 LabStyle Innovations Corp ... Management Tool, today announced that the Company,s Chief Financial Officer, ... Conference being held June 1-2 in New York, ... June 7-9 in Los Angeles, CA. ... corporate and operational milestones, including the U.S. FDA Clearance and ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... Southland Log Homes , designer and manufacturer ... barn kits, which can be found on its website at SouthlandLogHomes.com. , The designs ... and they highlight the craftsmanship of timber post and beam construction. The result ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... W.S. ... products, announced today that it has been recognized as one of the best small ... Badger was named as one of nine small businesses providing progressive benefits to new ...
(Date:5/27/2016)... ... 27, 2016 , ... With over 60 percent of acute stroke survivors being ... product to aid in the rehabilitation process has steadily increased. Ekso Bionics had been ... hemiplegia due to stroke. , Ekso Bionics has now received clearance from the U.S. ...
(Date:5/27/2016)... ... May 27, 2016 , ... An educational campaign ... inspiring human-interest stories, courtesy of awareness-driven celebrities and thought leaders. It also provides ... associations and industry leaders such as Bioness. , As patients feel increasingly ...
(Date:5/27/2016)... ... 2016 , ... Beleza Medspa has initiated a new program to ... the first time that Coolsculpting is being used for for more than just cosmetic ... they meet the prescribed body-fat standard, measured by the circumference-based tape method. The ...
Breaking Medicine News(10 mins):