November 29, 2004

Initial Results Reported in Clinical Study of Honso Sho-Saiko-to -H09- for Hepatitis C; Data Presented at the First Annual Society of Integrative Oncology Conference New York

A Japanese herbal product, Sho-saiko-to (H09), is under a clinical phase II trial by Memorial Sloan-Kettering Cancer Center to determine its effect on hepatitis C patients. The preliminary results of the trial have been reported at the 1st Annual Society of Integrative Oncology Conference in New York on Nov. 18, 2004. The testing herbal product, Honso(R) Sho-saiko-to (H09), is manufactured and supplied by Honso Pharmaceutical Co. Ltd., headquartered in Nagoya, Japan, and branched in Phoenix.

Chronic hepatitis C is associated with significant morbidity (liver cirrhosis and hepatocellular carcinoma) and mortality. Current treatment is based on interferon and ribavirin. However, treatment options are limited for patients who are not candidates for interferon-based therapy. This study is titled "Sho-saiko-to for Patients with Chronic Hepatitis C Who Are Intolerant to Or Have Contraindication to Interferon-Based Therapy: A Phase II Study." Sho-saiko-to has been demonstrated in anti-fibrotic effect by inhibition of lipid peroxidation in hepatocytes and stellate cells in animal studies. It has also been shown to reduce aminotransferase levels and the incidence of hepatocellular carcinoma in hepatitis and liver cirrhosis patients.

According to the design of the clinical trial, 31 patients will receive Sho-saiko-to (H09) granules at 2.5 grams three times daily for 52 weeks. Ten patients have completed the treatment and the preliminary results have been reported. No serious adverse events have been attributed to Sho-saiko-to (H09) among all patients who enrolled in the trial.

Among the 10 patients who completed the study, reductions in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were observed in eight patients, and reduction of viral load was observed in four out of seven detectable patients. This suggests anti-inflammatory and anti-viral activity. Liver biopsy response is defined as decrease in Knodell score of 2 points or more after the treatment in a blind fashion by an expert pathologist. The histologic responses were observed in two of the 10 patients who completed the study. This suggests anti-fibrotic effect in chronic hepatitis C patients.

Japanese herbal medicine also known as Kampo is part of the East Asian Chinese medicine tradition. Kampo is fundamentally a clinical system based on the classical medical literature dating back to the Han Dynasty in ancient China. In Japan today, fully 75% of physicians use at least some of the traditional Kampo formulas. In the United States, Sho-saiko-to (H09) is available in granules through health professionals and in tablet as Liver Kampo to consumers.

For more information about this and other studies on Sho-saiko-to (H09), please visit or contact Jennifer Healy at Honso USA Inc., 4602 E. Elwood St., Suite 6, Phoenix, AZ 85040, Phone: 480-377-8787; e-mail: [email protected]