Clinical Trials in Hong Kong Yunzhi-PSP

PSP has been shown to manifest immunomodulatory and anticancer properties in both pre-clinical experiments and clinical trials. It has been
shown to reduce the side effects of radiotherapy and chemotherapy and has been used as an adjunct medical modality to conventional cancer treatment. Experiments suggest that PSP can boost the immune system and alleviate the symptoms of chemotherapy.

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Clinical Trial China phase 3

Based on the PSP´s significant findings in the investigated cancers of the Phase II trial, permission was granted by the Chinese Administration of Health Bureau to carry out a multi-center Phase III clinical trial. Fourteen hospitals including the eight who participated in the phase II trial conducted this randomized study from April 1996 to September 1997.

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Clinical trial China phase 2

Polysaccharide-peptide (PSP) is a protein bound polysaccharide isolated from the COV-1 strain of Yunzhi (Coriolous versicolor mushroom) and made from modern alcohol extraction techniques. Each capsule contains 0.34 grams of PSP. Experimental in-vitro and in-vivo studies have shown PSP inhibits the proliferation of cancer cells including P338 leukemia cells, S 180 cells, Ehrlich ascites, and stomach and lung cancer cells. It also inhibits the growth of some tumors such as the lymphatic tumor of human skin tissue cells. In addition, PSP affects the immune system of mice by stimulating the production of ?\interferons, increasing the phagocytic index and metabolic rate of the reticuloendothilial system and by raising the HC 50 (median hemolytic dose), IgG and PFC (plaque forming cell) values. Human in-vivo experiments have also shown PSP can modulate the immune system by helping to prevent and partly eliminate the side effects of radiation and chemotherapeutic agents used by cancer patients.

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Clinical trail China phase 1

Polysaccharide-peptide (PSP) is a protein bound polysaccharides isolated from the COV-1 strain of Yunzhi (Coriolous versicolor mushroom) and made from modern alcohol extraction techniques. Each capsule contains 0.34 grams of PSP. Experimental in-vitro and in-vivo studies have shown PSP inhibits the proliferation of cancer cells including P338 leukemia cells, S 180 cells, Ehrlich ascites, and stomach and lung cancer cells. It also inhibits the growth of some tumors such as the lymphatic tumor of human skin tissue cells. In addition, PSP affects the immune system of mice by stimulating the production of ?\interferons, increasing the phagocytic index and metabolic rate of the reticuloendothilial system and by raising the HC 50 (median hemolytic dose), IgG and PFC (plaque forming cell) values. Human in-vivo experiments have also shown PSP can modulate the immune system by helping to prevent and partly eliminate the side effects of radiation and chemotherapeutic agents used by cancer patients.

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Basty University herbal monographs

PSK fights cancers and tumors by inhibiting the growth of cancer cells and by “stimulating a host mediated response.” Natural Killer cells are also promoted to enhance the immune system. It is often used in conjunction with chemotherapy to increase cancer survival rates.  PSP is being proposed as an inhibitor of HIV replication based on an in vitro study

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Bioactive Polysaccharides from TCM Herbs as Anti-Cancer Adjuvants

Many fungal and plant derived bio active polysaccharides with a broad range of immunomodulatory activities are found in TCM. Some
such polysaccharides have been developed into drugs and showed clinical efficacy in controlled trials while the majority of such compounds remain as nutraceuticals with only preliminary research. Such polysaccharides are generally non-toxic and also possess other bio activities such as inducing differentiation, stimulating hematopoiesis, anti-metastasis, and antiangiogenesis, which make them ideal adjuvants in modern cancer therapy.

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American Cancer Society

Coriolus versicolor is a mushroom used in traditional Asian herbal remedies (see Chinese Herbal Medicine). Two substances extracted from
the mushroom, polysaccharides K (PSK) and polysaccharides-peptide (PSP), are being studied as possible complementary cancer treatments.
Versicolor polysaccharides (VPS), another extract from the mushroom that is sold as a dietary supplement in the United States, is also being studied. A polysaccharide is a carbohydrate formed by a large number of sugar molecules.

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Anticancer effects and mechanisms of polysaccharide?K (PSK): implications of cancer immunotherapy.

Abstract
Polysaccharide-K (polysaccharide-Kureha; PSK), also known as krestin, is a unique protein-bound polysaccharide, which has been used as a chemoimmunotherapy agent in the treatment of cancer in Asia for over 30 years. PSK and Polysaccharopeptide (PSP) are both protein-bound polysaccharides which are derived from the CM-101 and COV-1 strains of the fungus Coriolus versicolor by Japanese and Chinese researchers, respectively. Both polysaccharide preparations have documented anticancer activity in vitro, in vivo and in human clinical trials, though PSK has been researched longer and has therefore undergone more thorough laboratory, animal and clinical testing. Several randomized clinical trials have demonstrated that PSK has great potential as an adjuvant cancer therapy agent, with positive results seen in the adjuvant
treatment of gastric, esophageal, colorectal, breast and lung cancers. These studies have suggested the efficacy of PSK as an immunotherapy or biological response modifier (BRM). BRMs potentially have the ability to improve the “host versus tumor response,” thereby increasing the ability of the host to defend itself from tumor progression. The mechanisms of biological response modification by PSK have yet to be clearly and completely elucidated. Some studies suggest that PSK may act to increase leukocyte activation and response through up-regulation of key cytokines. Indeed, natural killer (NK) and lymphocyte-activated killer (LAK) cell activation has been demonstrated in vivo and in vitro, and recent genetic studies reveal increased expression of key immune cytokines in response to treatment with PSK. An antimetastatic action of PSK has also been demonstrated and is perhaps attributed to its potential to inhibit metalloproteinases and other enzymes involved in metastatic activity. PSK has also been shown to cause differentiation of leukemic cells in vitro, and this effect has been attributed to induction of differentiation cytokines. PSK has further been shown to have antioxidant capacity which may allow it to play a role as a normal tissue chemo- and radio-protector when used in combination with adjuvant or definitive chemotherapy and/or radiotherapy in the treatment of cancer, while it may also enable it to defend the host from oxidative stress. Interestingly, studies have also shown that PSK may actually inhibit carcinogenesis by inhibiting the action of various carcinogens on vulnerable cell lines. This action of PSK may play a role in preventing second primary tumors when an inducing agent, such as tobacco or asbestos, is suspected and may also prevent second malignancies due to the carcinogenic effects of radiotherapy and cytotoxic chemotherapy. Another very important aspect of chemoimmunotherapy, in general is that it may be used on debilitated patients such as those with AIDS and the elderly who might otherwise be denied potentially helpful adjuvant cytotoxic chemotherapy. Further determination of the mechanisms of these anti-cancer, immunostimulating and biological response modifying effects of PSK as well as of other protein-bound polysaccharides is certainly warranted. Indeed, with modern cellular and molecular biology techniques, a better understanding of the specific molecular effects of PSK on tumor cells as well as leukocytes may be determined. Much of the research that has been done on PSK is outlined in this paper and may serve as a foundation toward determining the mechanisms of action of this and other protein-bound polysaccharides in the treatment of cancer. This information may open new doors in the development of novel strategies for the treatment of malignancies using adjuvant immunotherapy in combination with surgery, chemotherapy and/or radiotherapy.

PMID: 12168863 [PubMed – indexed for MEDLINE]
PubMed
U.S. National Library of Medicine
National Institutes of Health
Publication Types, MeSH Terms, Substances
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Effect of Krestin as adjuvant treatment following radical radiotherapy in non?small cell lung cancer patients.

Hayakawa K, Mitsuhashi N, Saito Y, Nakayama Y, Furuta M, Nakamoto S, Kawashima M, Niibe H.
Department of Radiology and Radiation Oncology, Gunma University School of Medicine, Japan.

Abstract
To evaluate the efficacy of Krestin (PSK) as adjuvant treatment after radical radiation therapy (RT) for non-small cell lung cancer (NSCLC), treatment results of 225 patients with NSCLC treated with RT followed by adjuvant administration of PSK between 1976 and 1989 were analyzed. Of these patients, 170 (76%) had squamous cell carcinoma. In the patients with squamous cell carcinoma of the lung, PSK was given only when the tumor showed satisfactory shrinkage (complete or partial response) after completion of RT. The treatment outcomes were compared with those of the responders to RT not receiving PSK. The 5-year survival rates of patients with stages I-II and stage III disease were 39 and 26%, respectively, while the non-administered responder group’s were 17 and 8%. These differences are statistically significant. An improvement in the treatment results with combined use of appropriate immuno-modulating drugs is anticipated in the future. When clinical trials of the efficacy of these drugs are conducted, the agents should be given to the patients with satisfactory tumor regression after RT, although they still take much time and cost.

PMID: 9043766 [PubMed – indexed for MEDLINE]
PubMed
U.S. National Library of Medicine
National Institutes of Health
Publication Types, MeSH Terms, Substances

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The immunomodulator PSK induces in vitro cytotoxic activity in tumor cell lines via arrest of cell cycle and induction of apoptosis

Protein-bound polysaccharide (PSK) is derived from the CM-101 strain of the fungus Coriolus versicolor and has shown anticancer activity in vitro and in in vivo experimental models and human cancers. Several randomized clinical trials have demonstrated that PSK has great potential in adjuvant cancer therapy, with positive results in the adjuvant treatment of gastric, esophageal, colorectal, breast and lung cancers. These studies have suggested the efficacy of PSK as an immunomodulator of biological responses. The precise molecular mechanisms responsible for its biological activity have yet to be fully elucidated.

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