1995S-0316
Volume 189
RPT 260

Cover Page

Letter from CFSAN to American BioSciences, Inc

New Dietary Ingredient Notification - Avemar

New Dietary Ingredient Notification - Fermented Wheat Germ

Certification

77 days-long toxicity study of Avemar (MI) in F344 rats and in C57BL/6 mice

Effects of Avemar Treatment on Quality of Life in Terminal Lung Cancer

Supportive Effects of Avemar in Breast Cancer

Csik, Marta, M.D. Genotoxicology Analysis of Avemar and Azoxymethane in the Rat's Marrow Micro-Nucleus Test.

Demidov, LV et al. A medical nutriment supports dacarbazine treatment in stage III melanoma.

Pre-publication study redacted

Hidvegi M, E Raso, R Tomoskozi-Farkas, S Paku, K Lapis, B Szende. 1998. Effect of Avemar and Avemar + vitamin C on tumor growth and metastasis in experimental animals. Anticancer Research Internat J Cancer Res and Treatment 18: 2353-2358.

Hidvegi M, E Raso, R T Farkas, K Lapis, B Szende. 1999. Effect of MSC on the immune response of mice. Immunopharmacol 41: 183-186.

Jakab F, Y Shoenfeld, A Balogh, M Nichelatti, A Hoffmann, Z Kahan, K Lapis, A Mayer, P Sapy, F Szentpetery, A Telekes, L Thurzo, A Vagvolgyi, M Hidvegi. 2003. A medical nutriment has supportive value in the treatment of colorectal cancer. Br J Cancer 89: 465-469.

National Institute of Chemical Safety, “Fodor Jozsef’ National Center of Public Health. 2004. Chemo-prevention of the toxicity of nickel, and of the mutagenic toxicities of cobalt, urethane and formaldehyde in Drosophila melanogaster by Avemar. Budapest. [Unpublished report]

Necropsy Co. Ltd. [undated]. Effect of long-lasting adjuvant Avemar treatment on the hematologic status of carcinoma patients. Budapest. [Unpublished report]

Szende B, Z Marcsek, Z Kocsis, A Tompa. 2004. Effect of simultaneous administration of Avemar and cytostatic drugs on viability of cell cultures, growth of experimental tumors, and survival of tumor-bearing mice. Cancer Biotherapy & Radiopharmaceuticals 19: 343-349.

2 Pre-publication studies redacted

University of Veterinary Science, Department of Pharmacology and Toxicology. 1999a. Acute oral toxicity study of Avemar in mouse: Final report. Budapest. [Unpublished report]

University of Veterinary Science, Department of Pharmacology and Toxicology. 1999b. Acute oral toxicity study of Avemar in rats: Final report. Budapest. [Unpublished report]

University of Veterinary Science, Department of Pharmacology and Toxicology. 2000. Subacute oral toxicity study of Avemar with 28-day treatment and 14-day post-treatment period in rat: Report. Budapest. [Unpublished report]

Zalatnai A, K Lapis, B Szende, E Raso, A Telekes, A Resetar, M Hidvegi. 2001. Wheat germ extract inhibits experimental colon carcinogenesis in F-344 rats. Carcinogenesis 22: 1649-1652.