Title: Preclinical and safety studies of V-1 Immunitor

Authors: Vichai Jirathitikal, Aldar S. Bourinbaiar

Addresses: Immunitor Corporation, Co. Ltd., 71 Moo 5, Bangpakong Industrial Park, Takarm, Chachoengsao 24130, Thailand. ' Immunitor USA Inc., College Park, MD 20740, USA

Abstract: The safety of V-1 Immunitor (V1) has been investigated. L929; BHK; Vero; Caco-2 and CEM-SS cells have not shown cytotoxicity even at 10 mg/ml dose. Ames| mutagenicity and micronucleus genotoxicity tests came out negative at 50 mg and 2000 mg/kg doses in Salmonella and bone marrow of IRC mice. Acute and chronic dosing of V1 to Swiss albino mice and Spague Dawley rats failed to cause any deaths. The LD50 is higher than 26.66 g/kg daily dose of V1, which corresponds to 1.9 kg or 2200 V1 pills. Liver and kidney and other biochemical and blood parameters remained normal. In Phase I study about 9% of HIV-positive patients reported mild adverse reactions which did not last more than one week. Over 70,000 individuals have safely used V1 in past six years. Thus V1 is safe and the risk of toxicity or adverse events is negligible compared to the clinical benefit.

Keywords: AIDS immunotherapeutics; toxicity; safety; antigens; magnesium; mucosa; human immunodeficiency virus; HIV; food supplements; immunogens; preclinical studies; V-1 Immunitor; V1; immunity.

DOI: 10.1504/IJBT.2007.014250

International Journal of Biotechnology, 2007 Vol.9 No.3/4, pp.318 - 331

Published online: 27 Jun 2007 *

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