A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of External Genital Warts

This trial will be a phase 2, open-label, study to evaluate the safety, tolerability, and
efficacy of VIR007 when administered topically for up to 60 days to adults between the ages
of 18 to 65 years with a clinical diagnosis of external condylomata acuminata.

Subjects will enter the Screening Period once the informed consent process has been
completed. Subjects with a clinical diagnosis of external condylomata acuminata and who meet
all inclusion and none of the exclusion criteria will be enrolled.

Once subject eligibility is confirmed and the screening procedures completed, the subject
will start the Treatment Period of the study. All enrolled subjects will receive VIR007
(cream containing 10% EISO) with the first dose applied topically during Visit 1 (Day 1).
Subjects will be instructed on how to apply the study medication twice daily for up to 60
days or until the Investigator determines the lesions have cleared. Subjects will return to
the clinic for study-related assessments on Study Days 7, 14, 28, 42 and a Final Study Visit
on Day 60. 30 days following complete resolution, as determined by the study investigator,
or, on Study Day 90, subjects will receive a follow-up telephone call and be queried
regarding condition status since study completion.

Inclusion Criteria:

1. Are ≥18 but ≤65 years of age

2. Are in good general health, as confirmed by medical history

3. Have a clinical diagnosis of condylomata acuminata with ≥2 but ≤10 visible external
genital warts (EGWs)

4. Have EGW lesions <200mm2

5. Are free of any systemic or dermatologic disorder, which, in the opinion of the
investigator, will interfere with the study results or increase the risk of adverse
events.

6. Must be willing to use a barrier method of birth control while enrolled in the study.

7. If female of childbearing potential, must have a negative urine pregnancy test result
prior to study treatment and must be willing to use a barrier method of birth control
while enrolled in the study.

8. Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or
creams, other than those issued as part of the study, on the affected areas during the
treatment period.

9. Are able to give written informed consent in a manner approved by the Institutional
Review Board or Ethics Review Committee and comply with the requirements of the study.

10. Are willing to avoid participation in any other clinical trial for the duration of
this study.

11. Are willing and able to participate as an outpatient, making regularly scheduled
visits to the study center during the treatment and to comply with all study
requirements including concomitant medication and other treatment restrictions.

12. Are willing to forgo all other treatments (prescription, nonprescription, and
nutritional supplements) for their EGWs.

Exclusion Criteria:

1. Have evidence of an active malignancy or have been immunocompromised within the 60
days prior to Screening.

2. Received any treatment for their EGW within 60 days of planned study enrollment.

3. Are pregnant, breast-feeding, or planning to become pregnant during the study.

4. Have EGWs ≥200mm2.

5. Have any evidence, currently or in the last 60 days, of herpes genitalis or any other
current and/or recurrent genital or uncontrolled infection that, in the opinion of the
investigator, could confound the results of the study including human immunodeficiency
virus (HIV), Hepatitis B, or Hepatitis C.

6. Have any abnormal skin conditions, body piercings, hypertrophic scarring or body
modification in the area that, in the opinion of the investigator, might affect the
accurate evaluation of EGWs.

7. Shares a household with a subject currently enrolled in the study.

8. Have any condition that, in the opinion of the investigator, would confound the safety
and/or efficacy assessments.

9. Have internal genital wart lesions, including the urethra, vagina and/or rectum.

10. If female, have any evidence of cervical dysplasia.

11. Have evidence of clinically significant or unstable disease (eg, stroke, heart
attack).

12. Have a known sensitivity to any of the constituents of the test product including
sensitivities to sandalwood oil, fragrances or any member of the Compositae family of
vascular plants (eg, sunflowers, daisies, dahlias, etc.).

13. Have a history of Bowenoid papulosis.

14. Have received any of the following within 90 days prior to study treatment:

- Interferon or interferon inducers

- Cytotoxic drugs

- Immunomodulators or immunosuppressive therapies (inhaled/intranasal
corticosteroids are permitted)

- Oral or parenteral corticosteroids

- Topical corticosteroids if greater than 2 gm/day

- Any dermatologic procedures or surgeries on the study area (including EGW
treatments)

15. Have a history of alcohol abuse, or suspected alcohol abuse, in the past two years.