Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that by the end of June, two new clinical sites - in Newark, New Jersey and Philadelphia, Pennsylvania - will be ready to enroll patients in a Phase 2 study to test low-dose interferon alpha lozenges administered orally to HIV-positive subjects with oral warts. The Company’s goal is to add five more clinical sites in the next 90 days to ensure the timely enrollment and completion of the study.
Viral lesions of the mouth in patients infected with HIV are common and may be indicative of disease progression. One of the causes of oral lesions is a group of DNA viruses, human papilloma viruses, which induce hyperplastic lesions in the oral soft tissue such as papillomas, warts, condylomata and focal epithelial hyperplasia. Oral warts cause a significant reduction in quality of life due to their deleterious effects on patient appearance and potential for causing discomfort during routine activities such as eating and talking. Current treatment modalities include physical interventions such as cryosurgery, electrocoagulation, CO2 laser and excision; however, the rate of recurrence is high.

Two previous studies demonstrated the ability of interferon alpha lozenges to significantly reduce oral wart load in HIV-positive patients. If, as anticipated, ABI’s new study demonstrates the efficacy and safety of this treatment regimen, ABI intends to conduct a Phase 3 study before filing an NDA (New Drug Application), seeking marketing approval for interferon alpha lozenges in the treatment of oral warts in HIV-positive patients.

Clinical sites in Baltimore , Boston , Chicago , Dallas , New York and San Francisco are already open for enrollment. In all, 80 patients will be enrolled in a study in which treatment will last 24 weeks. Interested patients are urged to contact Martin Cummins, Director of Clinical and Regulatory Affairs at 806-376-1741 ext. 14 or email: mcummins@amarbio.com.

The FDA’s Office of Orphan Products Development 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.

“Although anti-HIV drugs are quite helpful against most opportunistic infections in patients with HIV, the prevalence of papillomavirus, in the mouth and elsewhere, is increasing. Our Company’s mission is to obtain FDA approval for our low-dose oral interferon Alpha to treat oral warts and other diseases,” said Dr. Joseph M. Cummins, President and CEO, ABI. “This Phase 2 clinical study in conjunction with our ongoing Phase 2 clinical study in Turkey on Behcet’s disease, are two important steps in attaining our objective,” added Dr. Cummins.