Title: A proprietary fermented wheat germ extract in cancer and autoimmune clinicalstudies-A newparadigm

Abstract

Avemar is a proprietary fermented wheat germ extract with anticancer properties — a complex mixture of thousands of molecules. Most of them are chemically unidentified, yet present in constant ratios and quantities from batch to batch; standardized to methoxy-substituted benzoquinone markers, i.e. 2,6-Dimethoxy-p-benzoquinone and 2-Methoxy-benzoquinone, which are the oxidation products of the corresponding hydroquinones. The benzoquinones are locked in raw wheat germ as glycosides and, during fermentation, the fermenting organism, Saccharomycescerevisiaeunlocks them as aglycones by the action of glycosidases. In animal experiments and in vitro cell lines, Avemar has shown significant anticancer, immunomodulatory, and anti-inflammatory properties. In addition, its active compounds impair the functional manifestation of the malignant metabolic phenotype, such as the Warburg effect, the pentose-phosphate-pathway, ribonucleotidereductase, and poly-(ADP)-ribose-polymerase, and repair the operation of the transformed mitochondria in neoplastic tissues. The proprietary wheat germ extract has a firmly established safety profile and has gained a self-affirmed Generally Recognized As Safe (GRAS) status. Manufactured in a GMP pharmaceutical plant in Kunfeherto, Hungary, and distributed as a nonprescription dietary supplement worldwide; in some countries of the European Union, Avemar is a dietary FSMP—Food for Special Medical Purposes—for cancer patients. Eleven open-label clinical studies have verified Avemar’s benefits on cancer, mostly in combination with standard oncology treatments. The clinical oncology studies include colorectal, lung, breast cancers, cancers of the oral cavity, hematology-oncological cancers, advanced melanoma, head-and-neck cancer, refractory prostate cancer, and a matched-pair study in children with solid tumors. Two clinical studies verified Avemar’s benefits in treating autoimmune diseases, a non-randomized study in refractory rheumatoid arthritis and a double-blind, randomized study in lupus (SLE) patients. This lecture presents the results of the clinical trials with Avemar.