Avemar, the product of industrial fermentation of wheat germ, possesses unique cancer-fighting characteristics. Taken orally, Avemar can inhibit metastatic tumor dissemination and proliferation during and after chemotherapy, surgery, or radiation. Benefits of Avemar treatment have been shown in various human cancers, in cultures of in vitro grown cancer cells, in the prevention of chemical carcinogenesis, and also in some autoimmune conditions. This document reviews the clinical and experimental results obtained with this extract so far. Special references are made for its safety, including its coadministration with anticancer drugs, as well as for its immunomodulatory activity, its molecular targets, and its use in cancer clinical trials.
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Nichelatti M
Experimental and clinical results with Avemar (a dried extract from fermented wheat germ) in animal cancer models and in cancer patients
In the late 1990's, reports were published about a biotech process by which a fermented wheat germ extract could be produced. The product, called Avemar, available as a water soluble granulate for oral consumption, has gained much attention from cancer researchers of several countries, like Israel, Hungary, the United States, England and Russia. Studies show biological activity of Avemar that may be useful for the treatment of neoplastic diseases, effects which can be well used in the treatment of certain immune disturbances and improvement in patient quality of life which can be independent from the previous ones. ANIMAL EXPERIMENTS: Avemar treatment resulted in a statistically significant decreases in metastases compared with controls, 71% with 3LL-HH tumor (Lewis lung carcinoma), 50% decrease with HCR-25 human colon carcinoma and 85% with B16 melanoma. When used in combination with chemotherapy, Avemar did not reduce cytotoxic effect on primary tumors, but dramatically enhanced antimetastatic effect. CHEMOPREVENTIVE EFFECTS: In F-344 rats colon carcinogenesis was induced by injections of azoxymethane (AOM), 83% of AOM only animals developed colon tumors, an average of 2.3 tumors each. In animals given Avemar prior and after AOM injections, 44.8% developed colon tumors, and average of 1.3 tumors each, reducing tumor development by 70%. CLINICAL STUDIES: NEW METASTASES AND PROGRESSION-FREE SURVIVAL IN CANCER PATIENTS: An early open-label phase II clinical trial with Avemar was conducted in colorectal cancer patients, involving 30 consecutive subjects undergoing curative surgery. Patients were divided into control cohort and Avemar cohort groups. Patients of the control group received adjuvant chemotherapy alone (if necessary), whereas patients of the Avemar group received adjuvant chemotherapy (if necessary) plus 9 grams of Avemar once or twice daily, depending on their body weight. The median follow-up of all patients was 9 months, with range 6-11 months. No patients treated with Avemar showed new metastases, while in the control group 4 patients (22%) did. Another multicenter trial to evaluate disease progression-free and overall survival enrolled 170 consecutive colorectal cancer subjects. End-point analysis observed progression-related events (relapsed tumors, new metastatic lesions, deaths) were significantly more abundant in the control cohort, The log-rank test showed significant differences in favor of the Avemar patients, in both the cumulative probabilities of disease progression-free survival (primary endpoint) and overall survivals. Among all analyzed covariates (age, sex, UICC staging, Avemar treatment, radiotherapy and chemotherapy), the only strong predictors of survival in the Cox proportional hazards model were UICC stage and Avemar treatment. The treatment with Avemar was generally safe (no serious adverse events were recorded.) The results showed highly significant data in favor of Avemar treatment: that this wheat extract, in combination with surgery plus standard radio/chemoptherapy, can significantly inhibit overall tumor progression including the formation of new metastases, and could prolong the survival of colorectal cancer patients.
A multicentric prospective open trial on the quality of life and oxidative stress in patients affected by advanced head and neck cancer treated with a new benzoquinone-rich product derived from fermented wheat germ (Avemar)
| Cella F, Chiavenna G, Ferrari C, Giannoni A, Iyer A, Kharkevitch GY, Nichelatti M, Ragni G, Ronzani G, Rovera GM, Sukkar SG |
Abstract Background and aim: Anorexia/cachexia syndrome is frequently correlated with increased oxidative stress (OS). A fermented wheat-germ extract with a standardized benzoquinone content (brand name Avemar) has been shown to exert an intense antioxidant activity with no side effects. The aim of this study was to investigate the effects of Avemar in patients affected by head and neck cancer, correlating the variations with OS with the quality of life as assessed by the Spitzer’s index. Patients and methods: A cohort of 60 patients affected by head and neck tumours (stage IIIa, IIIb, IV) were enrolled in the study following an open-label protocol. The patients were assigned to two subgroups, A or B. Group A was treated with conventional oncological therapy alone, and group B was treated with Avemar in addition to standard therapy. After 2 months only 55 patients survived and could be evaluated (29 in the control group and 26 in the Avemar group). Each patient was checked for circulating concentrations of hydroperoxides using the FRAS III test. Results: The levels of OS significantly decreased after 2 months in the group receiving Avemar (group). The value of Spitzer’s index was significantly higher in group B, attesting to an improved quality of life. Conclusion Although the specific active substance in Avemar has not yet been identified, the reduction in free oxygen radicals induced by it is correlated with a clinically significant improvement in the quality of life in patients with advanced cancer.
| D-ROMs test, diabetes, DOCA-salt, fermented wheat germ extract, Head and neck cancer, hypertension, metabolic syndrome, Oxidative stress, Quality of life, remodeling |
A medical nutriment has supportive value in the treatment of colorectal cancer
MSC (Avemar) is a medical nutriment of which preclinical and observational clinical studies suggested an antimetastatic activity with no toxicity. This open-label cohort trial has compared anticancer treatments plus MSC (9 g once daily) vs anticancer treatments alone in colorectal patients, enrolled from three oncosurgical centres; cohort allocation was on the basis of patients' choice. Sixty-six colorectal cancer patients received MSC supplement for more than 6 months and 104 patients served as controls (anticancer therapies alone): no statistical difference was noted in the time from diagnosis to the last visit between the two groups. End-point analysis revealed that progression-related events were significantly less frequent in the MSC group (new recurrences: 3.0 vs 17.3%, P<0.01; new metastases: 7.6 vs 23.1%, P<0.01; deaths: 12.1 vs 31.7%, P<0.01). Survival analysis showed significant improvements in the MSC group regarding progression-free (P=0.0184) and overall survivals (P=0.0278) probabilities. Survival predictors in Cox's proportional hazards were UICC stage and MSC treatment. Continuous supplementation of anticancer therapies with MSC for more than 6 months is beneficial to patients with colorectal cancer in terms of overall and progression-free survival.
| cohort study, colorectal cancer, Dacarbazine, fermented wheat germ extract, growth inhibition, progression-free and overall survival, progression-free survival |
Experimental and clinical results with Avemar (a dried extract from fermented wheat germ) in animal cancer models and in cancer patients
In the late 1990's, reports were published about a biotech process by which a fermented wheat germ extract could be produced. The product, called Avemar, available as a water soluble granulate for oral consumption, has gained much attention from cancer researchers of several countries, like Israel, Hungary, the United States, England and Russia. Studies show biological activity of Avemar that may be useful for the treatment of neoplastic diseases, effects which can be well used in the treatment of certain immune disturbances and improvement in patient quality of life which can be independent from the previous ones. ANIMAL EXPERIMENTS: Avemar treatment resulted in a statistically significant decreases in metastases compared with controls, 71% with 3LL-HH tumor (Lewis lung carcinoma), 50% decrease with HCR-25 human colon carcinoma and 85% with B16 melanoma. When used in combination with chemotherapy, Avemar did not reduce cytotoxic effect on primary tumors, but dramatically enhanced antimetastatic effect. CHEMOPREVENTIVE EFFECTS: In F-344 rats colon carcinogenesis was induced by injections of azoxymethane (AOM), 83% of AOM only animals developed colon tumors, an average of 2.3 tumors each. In animals given Avemar prior and after AOM injections, 44.8% developed colon tumors, and average of 1.3 tumors each, reducing tumor development by 70%. CLINICAL STUDIES: NEW METASTASES AND PROGRESSION-FREE SURVIVAL IN CANCER PATIENTS: An early open-label phase II clinical trial with Avemar was conducted in colorectal cancer patients, involving 30 consecutive subjects undergoing curative surgery. Patients were divided into control cohort and Avemar cohort groups. Patients of the control group received adjuvant chemotherapy alone (if necessary), whereas patients of the Avemar group received adjuvant chemotherapy (if necessary) plus 9 grams of Avemar once or twice daily, depending on their body weight. The median follow-up of all patients was 9 months, with range 6-11 months. No patients treated with Avemar showed new metastases, while in the control group 4 patients (22%) did. Another multicenter trial to evaluate disease progression-free and overall survival enrolled 170 consecutive colorectal cancer subjects. End-point analysis observed progression-related events (relapsed tumors, new metastatic lesions, deaths) were significantly more abundant in the control cohort, The log-rank test showed significant differences in favor of the Avemar patients, in both the cumulative probabilities of disease progression-free survival (primary endpoint) and overall survivals. Among all analyzed covariates (age, sex, UICC staging, Avemar treatment, radiotherapy and chemotherapy), the only strong predictors of survival in the Cox proportional hazards model were UICC stage and Avemar treatment. The treatment with Avemar was generally safe (no serious adverse events were recorded.) The results showed highly significant data in favor of Avemar treatment: that this wheat extract, in combination with surgery plus standard radio/chemoptherapy, can significantly inhibit overall tumor progression including the formation of new metastases, and could prolong the survival of colorectal cancer patients.
A multicentric prospective open trial on the quality of life and oxidative stress in patients affected by advanced head and neck cancer treated with a new benzoquinone-rich product derived from fermented wheat germ (Avemar)
| Cella F, Chiavenna G, Ferrari C, Giannoni A, Iyer A, Kharkevitch GY, Nichelatti M, Ragni G, Ronzani G, Rovera GM, Sukkar SG |
Abstract Background and aim: Anorexia/cachexia syndrome is frequently correlated with increased oxidative stress (OS). A fermented wheat-germ extract with a standardized benzoquinone content (brand name Avemar) has been shown to exert an intense antioxidant activity with no side effects. The aim of this study was to investigate the effects of Avemar in patients affected by head and neck cancer, correlating the variations with OS with the quality of life as assessed by the Spitzer’s index. Patients and methods: A cohort of 60 patients affected by head and neck tumours (stage IIIa, IIIb, IV) were enrolled in the study following an open-label protocol. The patients were assigned to two subgroups, A or B. Group A was treated with conventional oncological therapy alone, and group B was treated with Avemar in addition to standard therapy. After 2 months only 55 patients survived and could be evaluated (29 in the control group and 26 in the Avemar group). Each patient was checked for circulating concentrations of hydroperoxides using the FRAS III test. Results: The levels of OS significantly decreased after 2 months in the group receiving Avemar (group). The value of Spitzer’s index was significantly higher in group B, attesting to an improved quality of life. Conclusion Although the specific active substance in Avemar has not yet been identified, the reduction in free oxygen radicals induced by it is correlated with a clinically significant improvement in the quality of life in patients with advanced cancer.
| D-ROMs test, diabetes, DOCA-salt, fermented wheat germ extract, Head and neck cancer, hypertension, metabolic syndrome, Oxidative stress, Quality of life, remodeling |
Fermented wheat germ extract (Avemar) in the treatment of cancer and autoimmune diseases
Avemar, the product of industrial fermentation of wheat germ, possesses unique cancer-fighting characteristics. Taken orally, Avemar can inhibit metastatic tumor dissemination and proliferation during and after chemotherapy, surgery, or radiation. Benefits of Avemar treatment have been shown in various human cancers, in cultures of in vitro grown cancer cells, in the prevention of chemical carcinogenesis, and also in some autoimmune conditions. This document reviews the clinical and experimental results obtained with this extract so far. Special references are made for its safety, including its coadministration with anticancer drugs, as well as for its immunomodulatory activity, its molecular targets, and its use in cancer clinical trials.
A medical nutriment has supportive value in the treatment of colorectal cancer
MSC (Avemar) is a medical nutriment of which preclinical and observational clinical studies suggested an antimetastatic activity with no toxicity. This open-label cohort trial has compared anticancer treatments plus MSC (9 g once daily) vs anticancer treatments alone in colorectal patients, enrolled from three oncosurgical centres; cohort allocation was on the basis of patients' choice. Sixty-six colorectal cancer patients received MSC supplement for more than 6 months and 104 patients served as controls (anticancer therapies alone): no statistical difference was noted in the time from diagnosis to the last visit between the two groups. End-point analysis revealed that progression-related events were significantly less frequent in the MSC group (new recurrences: 3.0 vs 17.3%, P<0.01; new metastases: 7.6 vs 23.1%, P<0.01; deaths: 12.1 vs 31.7%, P<0.01). Survival analysis showed significant improvements in the MSC group regarding progression-free (P=0.0184) and overall survivals (P=0.0278) probabilities. Survival predictors in Cox's proportional hazards were UICC stage and MSC treatment. Continuous supplementation of anticancer therapies with MSC for more than 6 months is beneficial to patients with colorectal cancer in terms of overall and progression-free survival.
| cohort study, colorectal cancer, Dacarbazine, fermented wheat germ extract, growth inhibition, progression-free and overall survival, progression-free survival |