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Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study 

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Presentation on theme: "Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study "— Presentation transcript:

1 Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study  Sangita P. Patil, PhD, Julie Wang, MD, Ying Song, MD, Sally Noone, RN, Nan Yang, PhD, Sylvan Wallenstein, PhD, Hugh A. Sampson, MD, Xiu-Min Li, MD  Journal of Allergy and Clinical Immunology  Volume 128, Issue 6, Pages e2 (December 2011) DOI: /j.jaci Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

2 Fig 1 Suppression of allergen-stimulated basophil activation by FAHF-2 in a 6-month phase I clinical study. Patients’ blood before treatment (0 months) and at consecutive 2-month time points during a 6-month clinical phase I study for FAHF-2 was stimulated with increasing doses of allergen in the presence of stimulation buffer. Percentages of CD63 cells for 200 ng/mL (A), 200 pg/mL (B), and 0.2 pg/mL (C) of allergen are shown. ∗P < .05 and ∗∗P < .01. Symbols represent individual patients, and bars are medians from each group. Journal of Allergy and Clinical Immunology  , e2DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

3 Fig 2 Effect of FAHF-2 on IL-3–, anti-FcɛRI–, and fMLP-stimulated basophils in a 6-month phase I clinical trial. Patients’ blood before treatment (0 months) and at consecutive 2-month time points during a 6-month clinical phase I study for FAHF-2 was stimulated in the presence of stimulation buffer alone (A), stimulation buffer plus anti-FcɛRI (B), and stimulation buffer plus fMLP (C). Journal of Allergy and Clinical Immunology  , e2DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

4 Fig 3 Effect of FAHF-2 treatment on basophil and eosinophil percentages. Patients’ blood at baseline and after 6 months of a clinical phase I study for FAHF-2 was stimulated in the presence of stimulation buffer alone or stimulation buffer with anti-FcɛRI, fMLP, and allergen dilutions. Basophil (A) and eosinophil (B) percentages are shown. Symbols indicate an individual patient, and bars show median values. A P value of less than .05 was considered significant. Journal of Allergy and Clinical Immunology  , e2DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

5 Fig E1 HPLC fingerprints. FAHF-2 tablets obtained from the same batch were tested at time points before the studies. A, HPLC result of an FAHF-2 tablet generated in July B, HPLC result of an FAHF-2 tablet generated in July 2008. Journal of Allergy and Clinical Immunology  , e2DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

6 Fig E2 Gating strategy for the BAT. Aliquots of patients’ blood were stimulated with either IL-3 containing stimulation buffer alone (negative control) or stimulation buffer with anti-FcɛRI, fMLP, or antigen in the presence of anti-CCR3–fluorescein isothiocyanate– and anti-CD63–phycoerythrin–labeled mAbs. A, Basophils were gated as CCR3+ cells and distinguished from eosinophils on the basis of low side scatter. CD63+ cell percentages were identified as CCR3+ basophils expressing the activation marker CD63. B, Representative dot plots of allergic patients’ blood sample stimulated with stimulation buffer alone or stimulation buffer plus peanut (200 ng/mL) and a healthy subject’s blood stimulated with stimulation buffer plus peanut antigen (200 ng/mL). Journal of Allergy and Clinical Immunology  , e2DOI: ( /j.jaci ) Copyright © 2011 American Academy of Allergy, Asthma & Immunology Terms and Conditions

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