Clinical Phase II Study on Promising Japanese Botanical Formula

​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 (now TCM Zone)

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.

The 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
is contraindicated.

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
another year.

“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
the past.

We have demonstrated a high level of quality control and the excellent documentation supporting each facet of our manufacturing of Sho-Saiko-to.”

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 speciallytrained pharmacists.

Kampo research in Japan has always been more rigorous by western standards in the mold of conventional pharmaceutical research.

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.

All this translates into the fact that Honso’s Sho-Saiko-to (H09) is of the highest quality available, ensuring accurate results in the study.

DESCRIPTION

Ingredients (daily amount of raw herb in gram)

Bupleurum Root (Chai hu) 8.89g Pinellia Tuber (Ban xia) 5.56g Scutellaria Root (Huang qin) 3.33g
Jujube (Da zao) 2.22g Ginseng (Ren shen) 3.33g Licorice (Gan cao) 3.33g Ginger (Sheng jiang) 3.33 g

*The information provided here is for

Ann’s NOTE: As usual there doesn’t appear to be a Phase III trial going forward.  This is because clinical trials cost millions of $ and the natural substance cannot be patented.  Thus NO pharmaceutical company has an interest.