E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy

Prior studies have shown that this Chinese herbal formulation is safe and well-tolerated in
food allergic individuals. While oral immunotherapy (OIT) can lead to desensitization, it
remains uncertain whether this treatment can lead to lasting protection. Therefore, this
study aims to use the Chinese herbal formula in combination with OIT to determine whether
sustained protection can be achieved. All subjects will receive multi-allergen OIT, along
with a 4 month course of omalizumab to provide added safety for the initial dose escalation
and build up phases. Subjects will be randomized to receive active Chinese herbal formula or
placebo. Subjects will be treated with OIT for 2 years and then food challenges will be
performed to assess for desensitization. For those who achieve desensitization, all
treatments will be discontinued and food challenges will be performed 3 months later to
assess for sustained unresponsiveness.

Inclusion Criteria:

- 6 through 40 years

- At least one of the following for each of the 3 study allergens: serum IgE >4 kU/L or
skin prick test >6mm

- dose limiting symptoms at a cumulative dose of <=444 mg protein for 3 allergens as
screening double-blind, placebo-controlled food challenge

- use of an effective method of contraception by females of child-bearing potential

- ability to ingest oat or corn with no allergic reaction

Exclusion Criteria:

- If baked milk or egg are tolerated (assessed by clinical report), then milk or egg may
not be included as a study allergen

- Any disorder in which epinephrine is contraindicated such as coronary artery disease,
uncontrolled hypertension, and serious ventricular arrhythmias

- History of other chronic disease requiring therapy (other than asthma, atopic
dermatitis, or rhinitis)

- History of eosinophilic gastrointestinal disease

- Current participation in any other interventional study

- Investigational drug use within 90 days

- Subject is on build-up phase of any allergen immunotherapy (prior to maintenance
dosing)

- Current uncontrolled moderate to severe asthma as defined by:

- FEV1 value <80% predicted (or PFR if unable to perform spirometry) or any
clinical features of moderate or severe persistent asthma baseline severity (as
defined by the 2007 NHLBI Guidelines) and greater than high daily doses of
inhaled corticosteroids (as defined for children and adults using dosing tables
from the 2007 NHLBI Guidelines).

- Use of steroid medications in the following manners: history of daily oral
steroid dosing for >1 month during the past year, having 1 burst or steroid
course within the past 6 months, or having >1 burst oral steroid course within
the past 12 months.

- Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in
the past 6 months for asthma.

- Use of systemic steroid medications (IV, IM or oral) for indications other than asthma
for > 3 weeks within the past 6 months

- Inability to discontinue antihistamines for the initial day of escalation, skin
testing or DBPCFC

- Use of Xolair® (omalizumab) within the past 6 months

- Known sensitivity to Xolair® (omalizumab) or to the class of study drugs

- Body weight more than 90 kg, or subjects with weight-IgE combination that yields a
dose requirement greater than 600 mg dosing

- Use of beta-blockers (oral), (ACE) inhibitors, angiotensin-receptor blockers or
calcium channel blockers

- Pregnancy or lactation

- Inability to swallow placebo capsules

- Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the subject's ability to comply with study
requirements