Viral lesions of the mouth in patients infected with HIV are common and may be indicative of disease progression.
Current treatment modalities include physical interventions such as cryosurgery, electrocoagulation, CO2 laser and excision. However, the rate of recurrence with these therapies is high.
Two previous studies demonstrated the ability of interferon alpha lozenges to reduce oral wart load in HIV-positive patients.
If the study demonstrates the efficacy and safety of this treatment regimen, the company intends to conduct a phase III study before filing a new drug application, seeking marketing approval for the interferon alpha lozenges.
The FDA has granted orphan drug designation to ABI for natural human lymphoblastoid interferon-alpha in the treatment of papillomavirus warts in the oral cavity of HIV-positive patients.