Fermented wheat germ extract

Fermented wheat germ extract (FWGE), also called fermented wheat germ powder (FWGP), is a concentrated extract of wheat germ derived from the germ (endosperm, or seed) of the wheat plant. FWGE, which was invented in the early '90s in Hungary, differs from ordinary wheat germ in that it is fermented with baker's yeast to concentrate biologically-active benzoquinones.

FWGE is available commercially and is sold under the trade name Avemar. In the U.S., the product is classified as a dietary supplement and is marketed as Ave by American BioSciences, Inc. (Blauvelt, NY). Avemar is manufactured in Hungary, by Biropharma Ltd. (a division of Biromedicina Corp.), where it is approved as a dietary food for cancer patients.

History of Development of FWGE

The process for manufacturing FWGE through fermenation with baker's yeast was first developed by Hungarian biochemist Albert Szent-Gyorgyi.^{[citation needed]} Szent-Gyorgyi suggested that certain natural compounds called quinones, specifically methoxy-sustituted benzoquinones, naturally present in wheat germ, could help regulate cell metabolism. Fermenting wheat germ with baker’s yeast concentrated the most effective metabolism-regulating quinones such as 2,6-DMBQ, Szent-Gyorgyi noted, so they could be taken as a supplement without the need to consume impractically large amounts of wheat germ.

In the 1990s, Hungarian chemist Mate Hidvegi along with Rita Tömösközi-Farkas, Károly Lapis, Erzsébet Rásó, and Béla Szende, developed and patented an industrial fermentation process for large-scale production of FWGE extract.

Research

FWGE has been the subject of research investigations involving isolated cells in vitro, animals, and human clinical trials. The inventors who hold the patent on the process for manufacturing FWGE (Mate Hidvegi, Rita Tömösközi-Farkas, Károly Lapis, Erzsébet Rásó, and Béla Szende) authored the majority of published research on the product to date.

Human clinical trials

A non-blinded, non-randomized, open-label clinical trial investigated the effects of FWGE on colorectal cancer. The FWGE treatment group included 66 patients who were already under treatment with standard care (i.e., chemotherapy and/or radiation) and elected to receive FWGE for 6 months in addition. The control group consisted of 104 patients who elected to receive standard care alone without FWGE. The rate of progression-related events was significantly lower in the FWGE group versus the control group (3.0% vs 17.3%, respectively), as was the incidence of new metastases (7.6% vs 23.1%) and mortality (12.1% vs 31.7%). Significant improvements in progression-free and overall survival probability were also noted in the FWGE group. However, the authors reported that, because the subjects were not randomly allocated to treatment, there were significant differences in the characteristics of the two groups at baseline (prior to FWGE therapy); namely, the control group was significantly older (66.1 vs. 61.7 years), had a greater proportion of patients who were receiving radiotherapy (53.8% vs. 27.3%) and a much shorter time interval from diagnosis to study entry (1.1 months vs. 11.2 months). In an open-label, non-randomized, non-blinded pilot trial in pediatric cancer patients with various solid cancers, the incidence of chemotherapy-related febrile neutropenia was lower in patients treated with FWGE (30 episodes, 24.8%) than in control patients (46 episodes, 43.4%).

Animal studies

In animals with transplanted human lung cancer, FWGE added to chemotherapy increased survival markedly. In rats exposed to a substance known to cause colon cancer (AOM), giving the rats FWGE reduced by 46% the number of animals developing colon cancer and reduced the size and number of tumors in those rats that did develop colon cancer. In mice with a variety of cancer types (highly metastatic lung cancer; melanoma, and human colon cancer), FWGE administered with vitamin C reduced metastasis (spread) of the cancers. Toxicity studies with FWGE showed no toxicity at levels several times above the amounts recommended for use.^{[citation needed]}

In vitro cell studies

FWGE was shown to have apoptotic effects in a variety of cultured cell types in vitro (i.e., HT-29 human colon carcinoma cells, estrogen-positive breast cancer cells, T-cell and B-cell tumor lymphocytic cells, and Jurkat cells). In HT-29 human colon carcinoma cells, FWGE inhibited cell growth at a half-maximal concentration (IC50) of 118 μg/mL after incubation for 7 days, and triggered cellular apoptosis (in 22% of cells) and necrosis (in 28% of cells) at a concentration of 3200 μg/ml after 24-hour incubation. In estrogen-positive breast cancer cells, combined incubation with FWGE (625 μg/mL) and tamoxifen (1 nM) resulted in a greater degree of cellular apoptosis than incubation with tamoxifen alone. in MIA pancreatic adenocarcinoma cells, FWGE displayed inhibitory effects on glucose consumption and RNA ribose formation, and led to increased synthesis of palmitate. FWGE was shown to stimulate the release of inflammatory cytokines in lipopolysaccharide-stimulated macrophages, inhibit the survival of activated myeloid cells, and increase the activity of stress kinases resulting in the activation of AP-1 transcription factor in HeLa cells.

Precautions

FWGE should not be taken by children or by women who are pregnant or breast feeding. It should not be taken by those who have undertaken organ or tissue transplants, or those who suffer from bleeding erosions or bleeding ulcers of the gastrointestinal tract, enteritis, colitis, or malabsorption syndrome. Patients taking prescription medicine should consult with their doctor before use.

External links

• Avemar Research Homepage
• Summary info on fermented wheat germ as cancer-treatment botanical/nutritional complement, by Memorial Sloan-Kettering Cancer Center's Website