US Patents
Patent Link |
Title |
Experimental Data |
| 7,048,932 | Preparation and standardization of immunomodulatory peptide-linked glucans with verifiable oral absorbability from coriolus versicolor | Bone Marrow activity |
| 6,767,563 | Immune functions | Immune Support |
| 6,746,675 | Physiologically active compositions based upon active ingredients of Basidiomycotina and Araliaceae | Cancer |
| 6,087,335 | RNase-CV (Coriolus versicolor) | Cancer |
| 5,824,648 | Rnase-cv (coriolus versicolor) | Cancer |
| 5,374,714 | Purified coriolus versicolor polypeptide complex | Cancer |
| 4,851,395 | Nitrogen-containing polysaccharide | Cancer |
NIH - Clinical Trial Data
Conclusions are provided for convenience. Please use the link to review article abstracts.
| Study Link | Clinical Study Conclusions |
| Wong 2005 | The purpose of this clinical trial was to evaluate the immunomodulatory effects of Yunzhi-Danshen capsules in post-treatment breast cancer patients. Eighty-two patients with breast cancer were recruited to take Yunzhi [50 mg/kg body weight, 100% polysaccharopeptide (PSP)] and Danshen (20 mg/kg body weight) capsules every day for a total of 6 months. EDTA blood samples were collected every 2 months for the investigation of immunological functions. Flow cytometry was used to assess the percentages and absolute counts of human lymphocyte subsets in whole blood. Plasma level of soluble interleukin-2 receptor (sIL-2R) was measured by enzyme-linked immunosorbent assay (ELISA). Results showed that the absolute counts of T-helper lymphocytes (CD4+), the ratio of T-helper (CD4+)/T suppressor and cytotoxic lymphocytes (CD8+), and the percentage and the absolute counts of B-lymphocytes were significantly elevated in patients with breast cancer after taking Yunzhi-Danshen capsules, while plasma slL-2R concentration was significantly decreased (all p < 0.05). Therefore, the regular oral consumption of Yunzhi-Danshen capsules could be beneficial for promoting immunological function in post-treatment of breast cancer patients. |
| Yang 2005 | The polysaccharide peptide (PSP) isolated from the mycelia of Chinese Medicinal fungus Coriolus versicolor has proven benefits in clinical trials in China but the mechanism of action has not been elucidated. In this study, HL-60 cell line was used to investigate the anti-proliferation and cell death process of PSP. The cytotoxicity of PSP on normal human T-lymphocytes was also evaluated. We show that PSP induced apoptosis of human promyelocytic leukemia HL-60 cells but not of normal human T-lymphocytes. The apoptotic machinery induced by PSP was associated with a decrease in Bcl-2/Bax ratio, drop in mitochondrial transmembrane potential, cytochrome c release, and activation of caspase-3, -8 and -9. Activation of the cellular apoptotic program is a current strategy for the treatment of human cancer, and the selectivity of PSP to induce apoptosis in cancerous and not on normal cells supports its development as a novel anticancer agent. |
| Wong 2004 | Immunostimulating polysaccharides extracted from the Chinese medicinal plant Yun Zhi (Coriolus versicolor) have been found to enhance various immunological functions, and Danshen (Salvia miltiorrhiza) to show beneficial effects on the circulatory system. In the present clinical study, we investigated if regular consumption of Yun Zhi and Danshen capsules could improve cellular immunity in healthy subjects. One hundred healthy subjects were recruited to take Yun Zhi (50 mg/kg body weight) plus Danshen (20 mg/kg body weight) or placebo capsules daily for four successive months and, after a 2-month wash-out period, crossover to take placebo or Yun Zhi plus Danshen capsules for four successive months. Flow cytometry was used to assess the lymphocyte subtypes and concentration of T helper (Th) cell cytokines in culture supernatant. Gene expression of cytokines and cytokine receptors of peripheral blood mononuclear cells (PBMC) was analyzed by cDNA expression array. Results showed that regular oral consumption of Yun Zhi-Danshen capsules could significantly elevate PBMC gene expression of interleukin (IL)-2 receptor, increase the percentage and absolute counts of T helper cell and ratio of CD4(+) (T helper)/CD8(+) (T suppressor and cytotoxic T) cell, and significantly enhance the ex vivo production of typical Th1 cytokine interferon-gamma from PBMC activated by phytohemagglutinin and lipopolysaccharide (all p<0.005). Such consumption had no adverse effects on liver and renal functions, and the biochemical bone profile. Therefore, regular consumption of Yun Zhi and Danshen could be beneficial for immunological functions by potential enhancement of cell-mediated immunity in healthy subjects without any adverse effects. |
| Tsang 2003 | BACKGROUND: Non-small cell lung cancer (NSCLC) is a leading cause of cancer deaths, and over 60% of patients present with advanced stages. Although polysaccharide peptides (PSP), isolated from the fungus Coriolus versicolor, have been reported to have anti-tumor effects, its clinical efficacy has not been properly evaluated. METHODS: Double-blind placebo-controlled randomized study to evaluate the effects of 28-day administration of PSP (Windsor Pharmaceutical, Hong Kong) on patients, who had completed conventional treatment for advanced NSCLC. RESULTS: Thirty-four patients, with no significant difference in their baseline demographic, clinical or tumor characteristics, or previous treatment regimes (P>0.05) were recruited into each of the PSP and control arms. After 28-day treatment, there was a significant improvement in blood leukocyte and neutrophil counts, serum IgG and IgM, and percent of body fat among the PSP, but not the control, patients (P<0.05). Although the evaluable PSP patients did not improve in NSCLC-related symptoms, there were significantly less PSP patients withdrawn due to disease progression, than their control counterparts (5.9 and 23.5%, respectively; P=0.04; OR 4.00). There was no reported adverse reaction attributable to the trial medications. CONCLUSION: PSP treatment appears to be associated with slower deterioration in patients with advanced NSCLC. |
| Kidd PM | Immunoceuticals can be considered as substances having immunotherapeutic efficacy when taken orally. More than 50 mushroom species have yielded potential immunoceuticals that exhibit anticancer activity in vitro or in animal models and of these, six have been investigated in human cancers. All are non-toxic and very well tolerated. Lentinan and schizophyllan have little oral activity. Active Hexose Correlated Compound (AHCC) is poorly defined but has shown early clinical promise. GrifolaFrondosa D-Fraction has limited proof of clinical efficacy to date, but controlled research is underway. Two proteoglycans from Coriolus versicolor - PSK (Polysaccharide-K) and PSP (Polysaccharide-Peptide - have demonstrated the most promise. In Japanese trials since 1970, PSK significantly extended survival at five years or beyond in cancers of the stomach, colon-rectum, esophagus, nasopharynx, and lung (non-small cell types), and in a HLA B40-positive breast cancer subset. PSP was subjected to Phase II and Phase III trials in China. In double-blind trials, PSP significantly extended five-year survival in esophageal cancer. PSP significantly improved quality of life, provided substantial pain relief, and enhanced immune status in 70-97 percent of patients with cancers of the stomach, esophagus, lung, ovary, and cervix. PSK and PSP boosted immune cell production, ameliorated chemotherapy symptoms, and enhanced tumor infiltration by dendritic and cytotoxic T-cells. Their extremely high tolerability, proven benefits to survival and quality of life, and compatibility with chemotherapy and radiation therapy makes them well suited for cancer management regimens. |
| Tsukagoshi 1984 | A polysaccharide preparation isolated from Coriolus versicolor (Fr.) Quel. of Basidiomycetes (PSK) predominantly consists of glucan and approximately 25% tightly bound protein. PSK was effective against various allogeneic and syngeneic animal tumors and has been given orally to cancer patients. Various suppressed or enhanced immune responses of tumor-bearing animals were restored to normal levels by the administration of PSK in the tumor models tested. The killer T cell activity was augmented in tumor-bearing mice by intraperitoneal or oral administration of PSK, and there was correlation between the PSK associated antitumor effect and the killer T cell activity. It was found that PSK competed with immunosuppressive substances isolated from tumor-bearing mice and that the intestinal immune system appeared to be modulated by oral administration of PSK. After oral administration of 14C- or 35S-labeled PSK to normal rats, it was found that small or large molecular substances appeared in the serum depending on the time elapsed after administration, an indication that large molecular size products were from the digestive tract. |