Amarillo Biosciences Announces Open Enrollment in Its Phase 2 Study of Orally Administered Interferon Alpha in the Treatment of Oral Warts in HIV-Positive Patients
- Category: Proteins and Peptides
- Published on Friday, 09 February 2007 02:00
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AMARILLO, TX, USA | Feb 08, 2007 | Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that patients are now being enrolled in its FDA Phase 2 study testing low-dose interferon alpha lozenges administered orally to human immunodeficiency virus (HIV)-positive subjects with oral warts. Six clinical sites are participating in the study in San Francisco, Chicago, Boston, Dallas, Baltimore and New York City.
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 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.
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.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 13.5% of Amarillo Biosciences shares and has provided over $17.8 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including Sjogren's syndrome, Behcet's disease, and opportunistic infections in patients who are HIV positive. In its 22-year history, ABI has invested nearly $37 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the ABI web site at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" of the Company's Form 10-KSB for the year ended December 31, 2005.
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Amarillo Biosciences, Inc.
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SOURCE: Amarillo Biosciences, Inc.