Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)

Inclusion Criteria

• •1. Patients with documented diagnosis of recurrent respiratory papillomatosis
• •2. Patients with measurable disease
• •3. Patients presenting at least one of the following severity criteria: Derkay score ≥ 8 , Voice handicap index (VHI) ≥11
• •4. Adult male and female subjects, age of 18 and above (≥18 yrs)
• •5. Patients with documentation on number of debulking procedures done during past 12 months
• •6. Estimated expectancy time for next debulking procedure must be at least 3 months.
• •7. Must be at least 4 weeks (\>4 weeks) since last treatment including cytotoxic therapy, biological or immunotherapy, anti-viral therapy, molecularly targeted therapy or steroid treatment.
• •8. Must be at least 2 weeks (\>2weeks) since last NSAID treatment.
• •9. Must have adequately recovered (to at least Grade 1 level) from adverse effects of prior therapies.
• •10. Female of child bearing potential must have a negative pregnancy test and must be practicing an effective method of birth control
• •11. Patients or their guardians must sign an informed consent indicating that they are aware of the investigational nature of this study