Sho-saiko-to Scheduled for Phase II Study

Sho-saiko-to Scheduled for Phase II Study

NEW YORK--Honso Pharmaceutical Co. Ltd. announced plans for a Phase II study of itsSho-saiko-to, a traditional Kampo formulation used in China and Japan, for slowing the development of cancer of the liver. The study will be conducted by Memorial Sloan-Kettering Cancer Center (www.mskcc.org) and will involve approximately 80 patients who will be treated over a two-year period, with an additional year of observation. Study participants will be selected from a pool of patients scheduled for ablative therapy, and the treatment regimen will consist of 7.5 g/d of Sho-saiko-to granular extract.

The study will be based on previous Japanese studies in which the blend demonstrated hepatoprotective, antiproliferative and immunostimulant effects in vitro, according to the company. The blend has also been shown to reduce the incidence of hepatocellular carcinoma and increase survival in cirrhotic patients as compared to patients receiving placebo. Sho-saiko-to's in vitro, in vivo and clinical activity seems to inhibit tumor proliferation rather than to kill tumor cells.