SAFETY OF FOOD ALLERGY HERBAL FORMULA (FAHF-2) IN PATIENTS WITH FOOD ALLERGY

Icahn School Of Medicine At Mount Sinai, New York NY

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Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Given the efficacy of treatment in the murine model and the safety profile at extremely high doses, we propose to test the safety of FAHF-2 in humans with IgE-mediated food allergies. Although FAHF-2 has been repeatedly tested in a murine model of peanut allergy, it is not specific for peanut allergy and should be effective for all IgE-mediated food allergies. We recently found that FAHF-2 inhibited milk antigen triggered histamine release by rat basophile leukemia cell lines (RBL) (unpublished data, see section 8). Given the favorable efficacy and safety profiles, and the non-antigen-specific approach observed in our preliminary study, we propose to test FAHF-2 in patients with peanut, tree nut, fish or shellfish allergies. These food allergies are typically persistent;and therefore it is unlikely that the subjects would have resolution of disease without treatment. Hypothesis: FAHF-2 will be shown to be a safe and effective treatment for food allergy