Study to Validate Fuzheng Huayu Composition as a U.S. Anti-fibrosis Treatment for Hepatitis C Nears Completion

During its Nov. 11 advisory board meeting at the 2012 Liver Meeting? of the American Association for the Study of Liver Diseases, Shanghai Sundise Traditional Chinese Medicine Co., Ltd. (Sundise) announced that the Phase II U.S. Clinical Trial to validate the botanical drug Fuzheng Huayu (FZHY) as a treatment for liver fibrosis in hepatitis C is close to completion. The company also invited the investigators and the data management team to review the study’s progress. “At this point, 73 percent of the patients have completed the post-treatment liver biopsy and 60 percent have finished the 60-week study” “At this point, 73 percent of the patients have completed the post-treatment liver biopsy and 60 percent have finished the 60-week study,” said Huashi Bian, Sundise CEO. “The last patient is expected to complete the study in February 2013.” Tarek Hassanein, MD, director of SCTI Research Foundation and lead principal investigator, confirmed that the study was progressing well, as planned, and the results are expected to be announced in the second half of 2013. He also added that, per the Data Monitoring Committee, no changes need to be made to the protocol. Manufactured by Sundise, FZHY is an approved anti-fibrotic drug for treating hepatitis B infection in China, Singapore and Hong Kong. Clinical trials conducted in China show FZHY improves hepatic inflammation, regulates fat metabolism, reduces liver fibrosis scores and inhibits fibrosis progression into cirrhosis. The U.S. Phase II trial was initiated in 2009 for the treatment of liver fibrosis in hepatitis C patients. It is a multicenter, double blinded and placebo-controlled trial evaluating treatment with FZHY for one year and pre- and post-treatment liver biopsy assessments. Detailed trial information is available at www.clinicaltrials.gov (Identifier: NCT00854087). A worldwide team of three pathologists has been formed to carry out the study’s next step: evaluating patients’ liver biopsies in a standardized and reliable manner. “State-of-art scanning technology on liver biopsy slides has made the international collaboration an easy process,” Bian added. “Once patients’ liver biopsy slides are scanned and stored on the centrally hosted web servers, three pathologists around the world will review digitalized images through secure Internet access.”