The botanical compound achieves a major milestone in drug development in the US
November 05, 2013 09:00 AM Eastern Standard Time
WASHINGTON--(BUSINESS WIRE)--Shanghai Sundise Traditional Chinese Medicine Co. Ltd released its multi-center, double-blinded, placebo-controlled clinical phase II trial results at a satellite symposium during the 2013 annual meeting of the American Association for the Study of Liver Diseases (AASLD®). The results indicate that in chronic hepatitis C patients with moderate to severe fibrosis Fuzheng Huayu tablet (FZHY) is safe, well tolerated and tended to stabilize and improve liver fibrosis, making FZHY the first traditional Chinese medicine compound to complete such clinical studies in the treatment of liver diseases.
“This study assured us about the safety and tolerability of FZHY and its previously reported effects on liver fibrosis in chronic hepatitis patient populations”
Hepatitis C is the major cause of liver fibrosis, cirrhosis and ultimately hepatocellular carcinoma (HCC) in the US. Newly approved direct-acting antiviral agents may effectively clear hepatitis C virus. However, the effects on underline liver fibrosis and cirrhosis remain to be seen. Currently, there is no FDA approved antifibrosis therapy. FZHY is a botanical compound approved in China for liver fibrosis caused by hepatitis B virus infection. This is the first clinical phase II trial of FZHY as a botanical drug to assess the safety, tolerability, and efficacy on fibrosis in HCV patients who have been previously failed by the anti-viral therapies, cannot receive or refused Interferon-based therapy. The trial was initiated in 2010 to evaluate FZHY with treatment protocol for one year and pre- and post-treatment liver biopsy assessments. The trial was funded by Shanghai Sundise Traditional Chinese Medicine Co. Ltd, with eight US medical institutions and a team of world-famous liver specialists working together. Detailed trial information is available at www.clinicaltrials.gov (Identifier: NCT00854087).
“This study assured us about the safety and tolerability of FZHY and its previously reported effects on liver fibrosis in chronic hepatitis patient populations,” stated Tarek Hassanein, MD., director of SCTI Research Foundation and lead principal investigator. “This study is a pivotal trial in bridging Eastern and Western medicine.”
“Our company took a unique approach in developing botanical medicines that are safe, effective and affordable,” said Huashi Bian, CEO and president of Shanghai Sundise. “This important milestone has positioned us in the innovative drug development area in the US.”
Prof. Ping Liu, one of the inventors of FZHY from Shanghai University of Traditional Chinese Medicine, indicated, “The long history of clinical usage and evidence-based clinical studies in China has supported this US phase II trial with sufficient data in safety and efficacies.”
FZHY is developed by Shanghai Sundise Traditional Chinese Medicine, Co., Ltd. which holds seventeen patents including five worldwide ones.
Shanghai Sundise Traditional Chinese Medicine Co., Ltd. is a technology corporation specialized in the modernization of Traditional Chinese Medicine, based in Shanghai, China. Sundise works closely with universities and research institutes across China and the United States to conduct studies on therapeutic compounds based on the Chinese traditional medicine. Learn more about Sundise and its products at http://www.sundise.com.
FDA: US Food and Drug Administration
AASLD: American Association for the Study of Liver Diseases
Shanghai Sundise Traditional Chinese Medicine Co., Ltd.
Jiayi Zhang, +86-21-52896028