Patient Enrollment Nearly Finished in Phase II U.S. Clinical Trial for Plant-Based Drug's Treatment of Liver Fibrosis in Hepatitis C Patients
SAN FRANCISCO--(BUSINESS WIRE)--At the annual Liver Meeting® of American Association for Study of Liver Diseases on Nov. 6, 2011, Professor Chenghai Liu, director of the Institute of Liver Diseases at Shanghai University of Traditional Chinese Medicine, revealed the botanical preparation Fuzheng Huayu (FZHY) and the newly identified compounds may help reverse liver fibrosis in hepatitis patients.
Liu and his research team made the conclusion after investigating FZHY's anti-fibrotic mechanism and active components in a liver fibrosis animal model. The examination showed FZHY inhibited liver fibrosis and reduced angiogenesis in liver-fibrotic mice.
After screening 21 components from the plant-based drug, using microvessel density and liver sinusoidal structural changes, Liu and his team identified several new compounds.
Liu stressed liver fibrosis reduction is critical in treating chronic liver diseases because liver cell damages such as inflammation normally stimulate several risk factors, including activation of hepatic stellate cells.
"The hepatic stellate cells are under a 'sleep' mode in normal conditions," he explained. "However, when stimulated by inflammatory factors, the hepatic stellate cells 'awaken,' secreting large amounts of collagen. The aggregated collagen forms dense and tough fibrous connective tissues, which is fibrosis."
Manufactured by Shanghai Sundise Traditional Chinese Medicine, Co., Ltd. (Sundise), FZHY is an approved anti-fibrotic drug for treating hepatitis B infection in China and Hong Kong. In a newly published, 16-hospital study (sponsored by Sundise) with 590 hepatitis B patients in China, FZHY's efficacy against liver fibrosis was 52-58.3 percent after the drug was administered for six months.
Other clinical trials conducted in China show FZHY improves hepatic inflammation, regulates fat metabolism, reduces liver fibrosis scores, and inhibits fibrosis progression into cirrhosis.
"While more U.S. clinical research studies are needed, our studies and patient use in China suggest FZHY may be an effective therapy to treat and prevent liver fibrosis in hepatitis patients," Liu said.
FZHY is not approved in the United States as a prescription drug. A double-blinded, placebo-controlled, multicenter phase II clinical trial co-sponsored by Sundise is under way in the United States. Patient screening is nearly complete.
"We're satisfied with the patient enrollment progress," said Dr. Tarek Hassanein from the SCTI Research Foundation in San Diego, lead principal investigator for the phase II trial. "Thanks to participation from eight clinical centers - including Baylor Clinic, University of Utah, UC Davis and Stanford University - we're on our way to finish enrolling 115 hepatitis C patients by the end of this year."
"We're very pleased to meet with the principal investigators from all clinical centers," said Huashi Bian, Sundise CEO and president. "FZHY has been used by hundreds of thousands of patients in China and has an established track record of safety and efficacy. It will help patients with hepatitis in the U.S. and around the world if FZHY composition continues its development as an anti-fibrotic compound through clinical trials."
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 life sciences companies, 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.
Contacts
Shanghai Sundise Co., Ltd.
James Chin, MD, 973-479-4312
james.chin@sundise.com