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AVEMAR - anticancer activity of fermented wheat germ extract

Avemar's anti-cancer effects were first demonstrated in animal experimental models which focused on tumour types widely used for the testing of anti-cancer agents, notably cytostatics.

A

Avemar is a complex of multiple, biologically active molecules obtained from fermented wheat germ extract. Preclinical studies suggest Avemar has potential activity in stimulating the immune system. Size 510g granulated substance. Helps boost the immune system. Avemar acts as an antioxidant, has antioxidative effect. Free radical quencher.

COMPOSITION
Dried, fermented wheat germ extract (63,2%), maltodextrine, fructose, silicium-dioxide (to prevent adherence), natural orange aroma, sodium chloride. To reach appropriate microbiological purity, Avemar is treated with ionizing energy.

USAGE
Preparation of a single dose: Take 1 sachet (17g) of Avemar in a glass. Fill up with 200 ml cold water, stir well, then drink liquid. Solution which was not consumed within a half hour period after preparation should not be used later!

DOSAGE
For patients of average weight 60-70kg (150 lbs.) a single dose (17g) of Avemar should be taken once a day, prepared as instructed, if possible approximately 1 hour before a meal. For patients weighing more than 90 kg (200 lbs.) the product should be taken twice daily. Taking one dose (17g) before breakfast and another dose (17g) before supper is recommended. The product may be taken with a cold soft drink or non-carbonated mineral water which does not contain vitamin C (ascorbic acid or E 300).

INDICATIONS
Using Avemar is recommended for patients suffering from malignant tumors as a supplement to clinical oncology treatment (surgery, radiotherapy, chemotherapy, immunotherapy etc.). The nutriment should be taken continuously without interruption during and after clinical treatment until it is recommended by the physician. Avemar can be used after surgery when the patient has been fed orally at least for 4 days without any difficulty.

CONTRAINDICATIONS
The product should not be taken during pregnancy or nursing (breastfeeding). Avemar’s use is prohibited for patients with organ or tissue transplant. The product cannot be used if the patient has bleeding gastrointestinal erosions (bleeding gastric or duodenal ulcer), enteritis/colitis (severe intestinal inflammation), malabsorption syndrome (severe absorption problem). Usage of the product is not advised in the presence of known gluten sensitivity (celiac sprue). Usage is also not advised in cases of hereditary fructose intolerance or if there is hypersensitivity to any compound of the product.

KNOWN INTERACTIONS
Avemar should not be taken in conjunction with any preparation containing vitamin C within the same two hour period. As Avemar can affect the absorption of other medications and therapeutic products, it is appropriate to maintain a 2-hour break between using Avemar and other medicines.

IMPORTANT WARNINGS
- Using Avemar is not a substitute for clinical oncology treatment and medications!
- This product should be used only by patients over 14-years of age!
- This product should be used only if recommended and supervised by a physician!
- This product should be kept strictly out of the reach of children!
- Usage of Avemar should be suspended for a period of 2 days before and after any gastrointestinal radiological diagnostic procedure involving usage of barium-sulfate!
- Can be used by diabetics if supervised by a physician with regard to its carbohydrate content.

STORAGE
Store product in its closed container between 5-15 oC (preferably in a refrigerator). Expiry date: See lid of box.

SIDE EFFECTS
Soft stool, unsettled stomach and nausea are infrequent side effects of Avemar.


Pancreas 2001 Aug; 23(2): 141-147.
Boros LG, Lapis K, Szende B, Tomoskozi-Farkas R, Balogh A, Boren J, Marin S, Cascante M, Hidvegi M.
UCLA School of Medicine, Harbor-UCLA Research and Education Institute, Torrance, California 90502, USA.

Wheat germ extract decreases glucose uptake and RNA ribose formation but increases fatty acid synthesis in MIA pancreatic adenocarcinoma cells
The fermented wheat germ extract with standardized benzoquinone composition has potent tumor propagation inhibitory properties. The authors show that this extract induces profound metabolic changes in cultured MIA pancreatic adenocarcinoma cells when the [1,2-13C2]glucose isotope is used as the single tracer with biologic gas chromatography-mass spectrometry. MIA cells treated with 0.1, 1, and 10 mg/mL wheat germ extract showed a dose-dependent decrease in cell glucose consumption. uptake of isotope into ribosomal RNA (2.4%, 9.4%, and 28.0%), and release of 13CO2. Conversely, direct glucose oxidation and ribose recycling in the pentose cycle showed a dose-dependent increase of 1.2%, 20.7%, and 93.4%. The newly synthesized fraction of cell palmitate and the 13C enrichment of acetyl units were also significantly increased with all doses of wheat germ extract. The fermented wheat germ extract controls tumor propagation primarily by regulating glucose carbon redistribution between cell proliferation-related and cell differentiation-related macromolecules. Wheat germ extract treatment is likely associated with the phosphorylation and transcriptional regulation of metabolic enzymes that are involved in glucose carbon redistribution between cell proliferation-related structural and functional macromolecules (RNA, DNA) and the direct oxidative degradation of glucose, which have devastating consequences for the proliferation and survival of pancreatic adenocarcinoma cells in culture. More abstracts

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AVEMAR is a natural immunomodulator in colorectal cancer

Clinical data shows that Avemar has an antimetastatic effect
BACKGROUND: AVEMAR is a per os applicable complex of multiple, biologically active molecules obtained from fermented wheat-germ extract. Preclinical studies suggest potent anti-metastatic activity and it has a favorable toxicity profile. It has been aimed in a pilot-scale, phase II clinical study to document whether or not AVEMAR as a support to surgery or plus chemotherapy adds any therapeutic benefit compared to the same combination without MSC in colorectal cancer. METHODOLOGY: From 1998 to June 1999, 18 control patients and 12 consecutive colorectal cancer patients respectively, were enrolled into this study. All patients underwent curative surgery. The control group (18 patients) received no other therapy or adjuvant chemotherapy alone. The AVEMAR group (12 patients) received AVEMAR alone or plus adjuvant chemotherapy. Until now, the median follow-up has been 9 months. RESULTS: Interim data of the study document that in the AVEMAR group no new metastases, neither hepatic nor other, have occurred, so far. On the contrary, several new metastases have developed in the control group. CONCLUSIONS: Orally administered AVEMAR is a potent candidate to be regarded as a supportive therapy to surgery or plus chemotherapy for colorectal cancer patients.


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Immunopharmacology 1999 Apr;41(3):183-186
Hidvegi M, Raso E, Tomoskozi Farkas R, Lapis K, Szende B.
Birochem, Budapest, Hungary.

Effect of MSC on the immune response of mice
The supposed immunostimulatory actions of MSC, a new fermented wheat germ extract standardized to its benzoquinone composition (trade name: AVEMAR) were studied examining blastic transformation of peripheral blood lymphocytes of mice treated with MSC. It was found that MSC significantly increased the degree of blastic transformation caused by Concanavalin A. Using the B10LP to C57Bl skin graft system, MSC (0.03 and 3.0 g kg(-1) applied orally) acted in favour of restoring the immune function. On the other hand, 2,6-dimethoxy-p-benzoquinone (DMBQ), applied in equivalent doses (0.012 and 1.2 mg kg(-l)), did not shorten the rejection time of skin grafts. The immune restoring effect, as well as the blastic transformation enhancing potential of MSC may be exploited in various cases of decreased immune response.


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Radiol Oncol 2000; 34: 240.
Jakab F, Mayer A, Hoffmann A, Hidvegi M


First clinical data of a natural immunomodulator in colorectal cancer


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Meeting of the International Association of Pancreatology and the American Pancreatic Association.
Boros LG, Lee W-NP, Hidvegi M, Go VLW Combines
Chicago, Illinois, USA, 1-5 November 2000.

Metabolic effects of fermented wheat germ extract with anti-tumor properties in cultured MIA pancreatic adenomocarcinoma cells


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Hepatogastroenterology 2000 Mar-Apr;47(32):393-5
Jakab F, Mayer A, Hoffmann A, Hidvegi M.
Department of Surgery, Uzsoki Teaching Hospital, Budapest, Hungary.

First clinical data of a natural immunomodulator in colorectal cancer
BACKGROUND/AIMS: MSC (trade-name AVEMAR) is a per os applicable complex of multiple, biologically active molecules obtained from fermented wheat-germ extract. Preclinical studies suggest potent anti-metastatic activity and it has a favorable toxicity profile. It has been aimed in a pilot-scale, phase II clinical study to document whether or not MSC as a support to surgery or plus chemotherapy adds any therapeutic benefit compared to the same combination without MSC in colorectal cancer. METHODOLOGY: From 1998 to June 1999, 18 control patients and 12 consecutive colorectal cancer patients respectively, were enrolled into this study. All patients underwent curative surgery. The control group (18 patients) received no other therapy or adjuvant chemotherapy alone. The MSC group (12 patients) received MSC alone or plus adjuvant chemotherapy. Until now, the median follow-up has been 9 months. RESULTS: Interim data of the study document that in the MSC group no new metastases, neither hepatic nor other, have occurred, so far. On the contrary, several new metastases have developed in the control group. CONCLUSIONS: Orally administered MSC is a potent candidate to be regarded as a supportive therapy to surgery or plus chemotherapy for colorectal cancer patients.


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Ehrenfeld M, Blank M, Shoenfeld Y
IMAJ Suppl 2000; 2: 32.

AVEMAR - (MSC), a new benzoquinone-containing natural product, immunomodulates experimental model of systemic lupus erythematosus


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Cancer Biother Radiopharm 1999 Aug; 14(4):277-289.
Hidvegi M, Raso E, Tomoskozi-Farkas R, Szende B, Paku S, Pronai L, Bocsi J, Lapis K.
1st Institute of Pathology and Experimental Cancer Research, Semmelweis Medical University, Budapest.

MSC, a new benzoquinone-containing natural product with antimetastatic effect
An orally applicable fermentation product of wheat germ containing 0.04% substituted benzoquinone (MSC) has been invented by Hungarian chemists under the trade name of AVEMAR. Oral administration (3 g/kg body weight) of MSC enhances blastic transformation of splenic lymphocytes in mice. The same treatment shortens the survival time of skin grafts in a co-isogenic mouse skin transplantation model, pointing to the immune-reconstructive effect of MSC. A highly significant antimetastatic effect of MSC has been observed in three metastasis models (3LL-HH, B16, HCR-25). The antimetastatic effect of MSC--besides the immune-reconstitution--may also be due to its cell adhesion inhibitory, cell proliferation inhibitory, apoptosis enhancing, and antioxidant characteristics, also observed in our in vitro experiments. It is even more noteworthy that combined treatment with MSC and one of the following antineoplastic agents (5-FU and DTIC)--both in wide use in every day clinical practice--exhibited a significantly enhanced antimetastatic effect in appropriate metastasis models (established from C38 mouse colon carcinoma and B16 mouse melanoma respectively) as compared to the effect elicited by any component of these therapeutic compositions (MSC + 5-FU and MSC + DTIC) administered alone. The results show that the fermented wheat germ extract (MSC) has more than an additive effect and synergistically enhanced the metastasis inhibitory effect of both antineoplastic agents studied till now. It is also worthy of mention that the synchronous treatment with MSC profoundly decreased the toxic side effects of the applied antineoplastic agents (decreased weight loss etc). Based on the biological effects of MSC--shown to be non-toxic by subacute toxicology studies--this product may be used as an adjuvant in the therapy of malignant neoplasia and other diseases caused by or following immune-deficiency.


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Orv Hetil 1999 May 16;140(20):1141-1143 (in Hungarian)
Baintner K.


A wheat germ preparation and its possible action


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Birochem Ltd., Budapest, Hungary.
Hidvegi M, Raso E, Tomoskozi-Farkas R, Paku S, Lapis K, Szende B.
Anticancer Res 1998 Jul-Aug;18(4A):2353-8

Effect of AVEMAR and AVEMAR + vitamin C on tumor growth and metastasis in experimental animals
Because of the observed immunostimulatory actions of a new fermented wheat germ extract--with standardized benzoquinone composition--we have investigated the eventual tumor growth- and metastasis-inhibiting effects of this preparation (AVEMAR) applied alone or in combination with vitamin C. Tumor models of different origin [a highly metastatic variant of the Lewis lung carcinoma (3LL-HH), B16 melanoma, a rat nephroblastoma (RWT-M) and a human colon carcinoma xenograft (HCR25)]--kept in artificially immunosuppressed mice were applied. The metastasis-inhibiting effects of the treatments have been studied both in the presence and in the absence (following surgical removal) of the transplanted primary tumors. Combined treatments with AVEMAR and vitamin C--administered synchronously--profoundly inhibited the metastasis formation in all the applied tumor models while, treatments with vitamin C alone did not exert such an inhibiting effect on the metastasizing process. The degree of the observed metastasis inhibition in certain models was significant, while in others--although it was meaningful--did not prove to be significant. It is noteworthy that treatment with AVEMAR alone in certain models exerted a more pronounced inhibiting effect on metastasis formation than the synchronous combined treatment with AVEMAR and vitamin C. Furthermore, if the time schedule of the combined treatment was changed (vitamin C--instead of being administered synchronously--was given one hour after the treatments with Avemar), the vitamin C rather decreased the metastasis inhibiting effect of AVEMAR. It should be mentioned however, that in the case of rat nephroblastoma, a different response was observed: while, in the case of synchronous combination significant inhibition of metastasis formation was observed, treatment with AVEMAR alone did not produce metastasis-inhibition. It is noteworthy that in this model the metastasis-inhibiting effect of the synchronous combination treatment proved to be even more pronounced if AVEMAR was administered in a 100 times smaller dose than its regularly applied dosage. Treatment with AVEMAR and vitamin C--administered in combination or separately--in the majority of experimental models (with the exception of rat nephroblastoma) did not inhibit the growth of the primary tumors. It is reasonable, therefore, to suppose that in the observed metastasis-inhibiting effect the eventual proliferation inhibiting effect of these remedies does not play an important role. According to the results of other experiments--carried out in our laboratory in parallel with those described here--AVEMAR proved to have a meaningful immunostimulatory effect. It might therefore be suggested that the observed metastasis-inhibiting effect of this preparation may be mainly due to its immunostimulatory properties. The possible therapeutic benefits of AVEMAR and AVEMAR plus vitamin C are also discussed.


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8th European Congress on Biotechnology
Rita Tomoskozi-Farkas, Mate Hidvegi
Budapest, Hungary, 17-21 August 1997

OPTIMIZATION OF CEREAL GERM FERMENTATION
One of the most important problems of cancer therapy is preventing metastasis. In the last few years researchers have been devoting more attention to immunostimulants and drugs of natural origin. Albert Szent-Gyorgyi worked on compound - 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) and 2-methoxy-benzoquinone (2MBQ) - which have anticancer and bacteriostatic effect as well. The aim of our work is to produce a drug of natural origin rich in 2-MBQ and 2,6-DMBQ which may suitable for in vivo experiments. By the reason of our previous studies we tried to increase the concentration of 2-MBQ and 2,6-DMBQ in wheat germ by yeast fermentation. To reach the optimal parameters of fermentation we used factorial design method. The simultaneous effect of reaction parameters and component concentrations on the 2,6-DMBQ formation was investigated.For the determination of the optimal 2,6-DMBQ formation the fermentation time was varied between 5 and 24 hours. The temperature range used was 25- 35 oC. The substrate - yeast ratio, the dried material - water ratio were varied between 1.5-3.5 and 5-10. We examined the effect of defatting of wheat germ, the intensity of mixing and light.


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Patologiai es Kiserleti Rakkutato Intezet, Semmelweis Orvostudomanyi Egyetem, Budapest.
Szende B, Raso E, Hidvegi M, Tomoskozine FR, Paku S, Pronai L, Bocsi J, Lapis K. I.
Orv Hetil. 1998 Nov 29;139 (48):2893-7.

A new benzoquinone-containing antimetastatic product
An orally applicable fermentation product of wheat germ containing 0.04% substituted benzoquinone (MSC) was invented by Hungarian chemists under the trade--name of AVEMAR. The following biological effects of this product were observed. Oral administration (3 g/kg body weight) of MSC enhances blastic transformation of splenic lymphocytes of mice. The same treatment shortens the survival time of skin grafts in co-isogenic mouse skin transplantation model, which points to immune-reconstructive effect of MSC. Highly significant anti-metastatic effect of MSC was observed in three metastasis models (3LL-HH, B16, HCR-25). The antimetastatic activity of MSC--besides the immune reconstitution--may also due to the cell-adhesion inhibitory, cell proliferation inhibitory, apoptosis-enhancing and antioxidant effects, which were also observed in our in vitro experiments. Based on the biological effects of MSC--which is non-toxic, according to subacute toxicology studies--this product may be used as an adjuvant in the therapy of malignant neoplasia and other diseases caused by or following immunedeprivation.

More abstracts

More about Avemar

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