Specific studies

The effect of the combination of in vitro tamoxifen and Avemar treatment was investigated on ER+ and ER- cell lines in order to detect possible agonistic or antagonistic reactions on: the cytotoxicity of in vitro Avemar treatment, the effects of Avemar on apoptosis, the cell cycle and the estrogen receptor activation. Apoptosis increased when Avemar was added to tamoxifen treatment. Furthermore the tumor growth inhibitory effect of Avemar on ER positive MXT mouse breast carcinoma as well as in T47/D xenograft models were comparable (equal or better) to standard endocrine treatments. On the other hand Avemar certainly did not reduce the effect of endocrine treatments. The antitumor activity of Avemar did not depend on the estrogen receptor status. It was concluded that supplementary therapy with Avemar in estrogen receptor positive breast cancer can enhance the effect of Tamoxifen.
Continuous supplementation of Avemar along with the anticancer therapies proved to be beneficial for colorectal cancer patients in terms of overall and progression-free survival. Furthermore the inhibition of RR and COX enzymes resulted in significant antitumor effects in patients suffering from colon carcinoma. Avemar has also shown significant metastasis inhibiting effect in several tumour models without eliciting toxic side effects. Meanwhile the anti-proliferative, apoptotic, adhesion-related and the free radical-forming effects of Avemar may also contribute to the less number of metastases observed in the experimental group. Based on the results Avemar has a supportive value and highly recommended in the treatment of colorectal cancer.
Cytotoxic activities of fermented wheat germ extract (Avemar) were observed in human gastric carcinoma cells. Avemar was found to dose-dependently inhibit the growth of gastric carcinoma cells possibly via an apoptosis-dependent pathway and to have an additive or synergistic effect on cytotoxic agents. Parallel drug treatment with Avemar and either 5-FU, Oxaliplatin or CPT-11 in colon cancer cell lines exerted additive to synergistic effects for all drugs.
Preliminary data showed that combination of routine DTIC chemotherapy and Avemar may decrease risk of relapse and postpone time of melanoma progression. Published preclinical results suggested that the anti-metastatic effect of Avemar is related to its cell adhesion inhibitory, cell proliferation inhibitory, apoptosis enhancing and antioxidant characteristics. Adjuvant fermented wheat germ extract (Avemar) nutraceutical improved survival of high-risk skin melanoma patients. Based on these results it is highly recommended to include of fermented wheat-germ-extract-based medical nutriment in the adjuvant protocols of high risk skin melanoma patients.
The quality of life of lung-cancer patients also afflicted with metastases is extremely poor, adversely affecting the efficiency of therapy as well as long-term survival. It is therefore particularly important to enhance their quality of life. Experiments have proven that Avemar has extremely powerful immune-modulation as well as tumour-inhibition effects. An open “pilot” clinical experiment had been carried out in order to clarify whether this product might be suitable for the supportive treatment of lung-cancer patients. Patients were monitored based on point by point answers given to questions on the questionnaire EORTC QLQ-C30 in order to assess their quality of life and related changes occurring. The survey was carried out at the beginning of the treatment and once every 12 weeks following continuous ingestion of Avemar. According to statistical analysis of the answers, a significant enhancement was observed in both the overall state of health and social viability of these patients, and their tendency to fatigue was also reduced considerably. There was also an improvement with regard to pains, lack of appetite and emotional state.
The Hungarian Association of Oral and Maxillofacial Surgeons (Magyar Arc-, Állcsont- és Szájsebészeti Társaság) has reviewed the research results related to Avemar and issued its opinion as follows: “For patients suffering from head- and neck tumors – primarily malignant tumorous diseases of the oral cavity, the progression of the disease can be slowed significantly, the five-year survival rate increased considerably, the quality of life improved, and the oxidative stress on the patients reduced by the long-term application of the supplementary formula Avemar. The Association considers the supportive treatment with the formula Avemar as an important part of the complex therapeutic protocols applied in stages II, III and IV of malignant tumorous diseases of the oral cavity.”
The metabolic response of cultured MIA pancreatic adenocarcinoma cells to fermented wheat germ extract was investigated in vitro. The metabolic changes observed in MIA cells provided explanations for the clinically detected weight gain and slow disease progression of colorectal cancer in patients treated with Avemar. By decreasing the glucose consumption of cancer cells even advance cancer patients gain weight during the treatments. As a result Avemar treated patients tolerated better the conventional oncological treatments: surgery, chemotherapy or radiotherapy. The progression of cancer was slower and the survival rate significantly increased among the Avemar patients comparing to the controll group.
Overall, it appears that FWGE exerts its cytotoxic and antimetastatic effects by a combination of direct cytotoxicity and immune modulation. In clinical use, FWGE is very well tolerated at the recommended dose and possesses a broad therapeutic window. Besides its antitumoral activity, FWGE seems to exert additional effects leading to improvement of quality of life. This might be in part explained by the metabolic changes in cancer patients induced by FWGE. Its interference with the PPP switching from nonoxidative to oxidative reaction leads to decreased nucleic acid synthesis from glucose to direct glucose oxidation and lipid synthesis. This in turn may result in weight gain of the patient and improvement of body shape. It is interesting to note, that FWGE has a similar metabolic effect and targets components of the PPP like the well known targeted drug imatinib (Glivec). In conclusion, available data suggest that FWGE has an interesting preclinical and clinical activity profile with no toxicity. It appears to exert its effects by a battery of diverse mechanisms, likely because of its multi-substance composition. The use of FWGE as a non-prescription medical nutriment for cancer patients seems maintainable and combined use with chemotherapy appears feasible.
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