A Novel Biologic Therapy for Perennial Allergic Rhinitis

This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept
study which will evaluate the effect of a proprietory mixed preparation of FDA approved
allergens (PMA) used as a sub-cutaneously administered immunotherapy for the management of
allergic rhinitis (perennial and seasonal). Participating study subjects will be required to
manifest the signs and symptoms of allergic rhinitis and test positive to at least six
allergens using a multi aeroallergen screen at the time of study recruitment . All subjects
will undergo standard allergen skin prick testing using six Multi-Test® PC skin prick test
devices (Lincoln Diagnostics, Decator, IL) or comparable skin testing technique for a total
of 48 Skin Prick Test (SPT). Approximately 36 total subjects will be enrolled.

Following a successful screening study visit and two week medication washout period, a 8 week
treatment period will be initiated with bi-weekly study visits being undertaken, through to
the end of immunotherapy, for assessment of therapeutic response and safety evaluations.
Efficacy evaluation will be monitored using validated instruments that assess study subject
clinical response, physician global assessment, and medication use. A safety assessment will
be undertaken one month following completion of treatment.

At the screening visit (Screening Visit) a potential study subject will be required to
fulfill the requirements of the study inclusion and exclusion criteria, will have a clinical
evaluation including medical history and physical examination, blood draw and performance of
skin testing. The study subject will then abstain from using intranasal steroids and
antihistamines for two weeks and then return to the clinic for administration of
sub-cutaneous PMA and post-treatment in-clinic safety evaluation. The latter evaluation
period will comprise approximately 60 minutes to assess the study subject's response to PMA
immunotherapy. Follow up clinic study visits will continue bi-weekly through 8 weeks and at
each of these visits the study subject will receive increasing doses of PMA immunotherapy and
will be evaluated for safety. Twice weekly clinical evaluation will also be performed.
Following the final administration of PMA immunotherapy, a one month follow-up safety and
clinical efficacy evaluation will be conducted by telephone or in the clinic. The duration of
the study will be approximately 14 weeks.

Inclusion Criteria:

- In the opinion of the investigator, the subject is capable of understanding and
complying with protocol requirements.

- The subject signs and dates a written, informed consent form and any required privacy
authorization prior to the initiation of any study procedures.

- The subject is a male or a non-pregnant, non-lactating female between the ages of 18
and 65.

- The subject is actively manifesting symptoms and signs of moderate to severe Perennial
Allergic Rhinitis (PAR) with or without Seasonal Allergic Rhinitis (SAR) component
defined as score of at least 28 on the Rhinoconjunctivitis Quality of Life
Questionnaire (RQLQ) and 6 on the Total Nasal Symptom Score (TNSS) scale. Scores will
be determined on the first and second visit (after the 14 day medication washout
period). Both scores exceeding their threshold on either day will qualify.

- Skin test strongly positive (wheal at least 5mm diameter and 2mm greater than negative
control) to at least 6 of 48 allergy skin prick tests including at least one species
of dust mite.

Exclusion Criteria:

- The subject has received any investigational compound within 30 days prior to
screening.

- The subject has received allergen immunotherapy or SLIT in a previous clinical study
or as a therapeutic agent within the past two years.

- The subject has a history or clinical manifestations of significant medical conditions
(cardiovascular, hepatic, infectious or renal disease, etc.) which in the opinion of
the investigator renders them unacceptable study subjects.

- The subject has a history of drug abuse (defined as any chronic illicit drug use) or a
history of alcohol abuse within 5 years prior to the screening visit.

- The subject is required to take excluded medications listed in Section 6.3.

- If female, the subject is pregnant or lactating or intending to become pregnant
before, during, or within 1 month after participating in this study; or intending to
donate ova during such time period.

- Subjects found to have on physical exam significant nasal polyps, septal deviation or
infectious sinusitis.

- The subject has a history of allergic rhinitis but is not currently manifesting active
signs and symptoms of the disorder.

- Subject has a history of cancer, other than squamous cell or basal cell carcinoma of
the skin that has not been in full remission for at least 5 years prior to Screening.
(A history of treated Cervical Intraepithelial Neoplasia (CIN) I, II, or CIN III is
allowed.)