Clinical Phase II Study on Promising Japanese Botanical Formula
'Sho-Saiko-to' For Treating Liver Cancer to Begin in New York
Prestigious NY Research Institution Selects Sho-Saiko-to from Honso
Pharmaceutical Co., Ltd
NEW YORK, Feb. 25, 2002
A Japanese formulation comprised of seven
Chinese herbs will be studied by Memorial Sloan-Kettering Cancer Center
(www.mskcc.org ) to determine its effect against liver cancer.
herbal formulation being tested, called Sho-Saiko-to (or H09 according
to the Japanese government registration number), is manufactured by
Honso Pharmaceutical Co., Ltd. (www.honso.com ) headquartered in Nagoya
Japan, with its US branch based in Tempe, Arizona.
This study is
entitled "Sho-saiko-to after Ablation for Non-Resectable Hepatocellular
Carcinoma: A Phase II Trial with Historical Control." Hepatocellular
carcinoma (HCC) has a poor prognosis, especially when surgical resection
Previous Japanese research on Sho-Saiko-to has
demonstrated its hepatoprotective, antiproliferative and immunostimulant
effects in vitro. Moreover, in a randomized trial, cirrhotic patients
receiving Sho-Saiko-to had a lower incidence of developing HCC and
greater survival compared to placebo.
There is sufficient clinical
pharmacokinetic and laboratory data on Sho-Saiko-to, especially with
respect to dosage, to warrant a Phase II trial. Sho-Saiko-to's in vitro,
in vivo and clinical activity seems to be primarily to inhibit tumor
proliferation rather than to kill tumor cells.
This clinical trial, under an IND approved by Food and Drug
Administration (FDA), uses a one-stage historical comparison design.
Patients scheduled for ablative therapy will be assessed for
eligibility, consented and administered 7.5 grams of granular extract
per day of Sho-Saiko-to.
The outcome used to power the trial is survival
at 15 months, the median survival of a historical cohort. For purposes
of secondary analyses, liver function, alpha-fetoprotein and
intervention-free survival will be compared between the treated cohort
and historical data.
The patients, approximately 80 in number, will be
treated over a two year period, and then their progress followed for
"We are very pleased to have had our product selected for study," stated
Dr. Dan Wen, President of Honso USA, Inc., the US subsidiary of Honso
Pharmaceuticals Co., Ltd. in Tempe, AZ. "And it's an added honor to be
able to go directly into a Phase II study due to the overwhelming body
of evidence that already exists on the successful use of Sho-Saiko-to in
We have demonstrated a high level of quality control and the
excellent documentation supporting each facet of our manufacturing of
Previously trained in the field of gastroenterology research at the Mayo
Clinic and at Washington University School of Medicine in St. Louis, Dr.
Wen's expertise in both conventional and traditional medicine has helped
spur on the rapid growth of Kampo medicine in the United States.
The Japanese herbal medicine that is 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, which are available in
almost all pharmacies by prescription, or under the advice of specially
Kampo research in Japan has always been more
rigorous by western standards in the mold of conventional pharmaceutical
Kampo is different from "Western-style" herbology, which uses individual
herbs or their standardized extraction. Kampo mixes together multiple
raw herbs, according to specific ancient formulas, and then performs an
extraction on the entire mixture. The combination of the specific herbs
and this specific extraction processes creates a remedy far more
effective than the total of each herb extracted individually. To
emphasize this, each Honso(R) product label states the raw herb amounts
as they are before the extraction process takes place.
translates into the fact that Honso's Sho-Saiko-to (H09) is of the
highest quality available, ensuring accurate results in the study.
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