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Published on 5/23/2006 in the Prospect News Biotech Daily.

Amarillo Biosciences plans phase 2 study of interferon alpha lozenges in oral warts

By Lisa Kerner

Erie, Pa., May 23 - Amarillo Biosciences, Inc. said it submitted a protocol to the Food and Drug Administration for a phase 2 study to test low-dose interferon alpha lozenges administered orally to human immunodeficiency virus-positive subjects with oral warts, common in HIV-infected patients and possibly a sign of disease progression.

Human papilloma viruses, one cause of oral lesions, induce hyperplastic lesions in the soft tissue such as papillomas, warts, condylomata and focal epithelial hyperplasia, according to a company news release.

Current treatment includes cryosurgery, electrocoagulation, CO2 laser and excision, all with a high rate of recurrence.

Amarillo Biosciences said two previous studies demonstrated the interferon alpha lozenges' ability to reduce oral wart load in HIV-positive patients.

Should the new study demonstrate the efficacy and safety of this treatment regimen, ABI plans to conduct a phase 3 study followed by the filing of a new drug application with the FDA.

The FDA has granted orphan drug status to Amarillo Biosciences for natural human lymphoblastoid interferon-alpha in the treatment of papilloma virus warts in the oral cavity of HIV-positive patients.

Amarillo Biosciences is a biotechnology firm located in Amarillo, Texas.


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