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Sho-saiko-to Clinical Study Results for Hepatitis C

November 29, 2004

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The following report concerns a study done with Hepatitis C patients who underwent interferon therapy and are classified “non-responders” to interferon. This means they have no other choices of treatment in the medical mainstream.

The results of this Sho-saiko-to study are only preliminary. This is just the first ten of thirty two patients.

The fact that Memorial Sloan-Kettering Cancer Center is conducting this research is very encouraging. Clearly, they bring quite a bit of scientific credibility to this study.

Anti inflammatory and anti viral activity were clearly suggested by the outcomes.

The fact that two of the ten patients had a statistically relevant improvement in biopsy scores is quite impressive. It was not long ago that doctors considered fibrosis non-reversible unless the underlying cause was removed.

Initial Results Reported in Clinical Study of Honso Sho-saiko-to -H09- for Hepatitis C

Sunday November 28, 11:55 pm ET

Data Presented at the First Annual Society of Integrative Oncology Conference New York

PHOENIX–(BUSINESS WIRE)–Nov. 28, 2004–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┬« 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, a total of 31 patients will receive Sho-saiko-to (H09) granules at 2.5 grams three times daily for 52 weeks.

Ten patients have already 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.

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