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Review 1
The product and its registration status
Avemar is a mixture of molecules with a standardized composition derived from chemically modified natural materials. The main component is wheat germ, from which several different substances are extracted. These substances are then altered chemically, through the use of enzymatic and microorganism-derived processes, or by means of fermentational and bio-technological transformation, all in conformation to the quality standards set out for pharmaceutical production (GMP, ISO 9001:2000). After their concentration, the active ingredients are extracted using various physicochemical processes and then molecularly encapsulated and formulated. The result is a semi-natural, semi-synthetic substance in granular form which must be dissolved in water before being ingested. Owing to its complex nature, Avemar contains numerous additional molecules besides its main ingredient. While these compounds are responsible for the peculiar taste of the product, their removal would weaken the product's effectiveness. As some of Avemar's active ingredients are slightly heat-sensitive, the final product must be kept under room temperature, in a refrigerator if possible.
Avemar first was launched as a dietary supplement in Hungary in autumn 1998.
On the basis of the results of animal experiments and toxico-logical studies, which showed significant anticancer activity and lack of toxicity, the regional research ethics boards of the National Health Council, Hungary approved the protocols of clinical studies on Avemar. Based on their results, the compound was registered as a nutriment for cancer patients. Avemar is the first product developed by Hungarian scientists since decades which has been registered and approved for its oncological indications.
Avemar was registered and approved as a medical nutriment for cancer patients by the National Institute of Food Hygiene and Nutrition, "Fodor József" National Center for Public Health, Hungary on 6 February 2002 (registration number: 503). The Chief Pharmacist Officer approved the license of Avemar on 11 March 2002 (reference number: OTH/97-46/2002 Office of the Chief Medical Officer, Hungary). The Ministry of Health, Hungary listed the product under non-prescription medical nutriments in its Health Bulletin of 1 July 2002. The retail price of the compound is officially controlled, and the product can only be sold in pharmacies. The National Institute of Pharmacy, Hungary qualified Avemar's production plant and quality assurance system as fulfilling the requirements for pharmaceutical manu-facturing in 2003 (reference number: 1127-100/38/2003).
While Avemar is not an alternative medicine, nor a dietary supplement, nor even a member of the group of so-called 'com-pounds with unproven effects', it is not a cancer treatment drug or cytostatic agent either. It is, however, the only nutriment in its cate-gory specifically approved for and used in supplemental treat-ments in oncological therapy.
Avemar was also registered as a special nutriment for cancer patients by the Ministries of Health of the Czech Republic (registration number: HEM-3512-13.103-1178) and Bulgaria (registration number: 05180/2003) in 2003.
Avemar is currently available in 10 countries.
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