Published:
Amarillo Biosciences Announces Phase II Study of Orally Administered Interferon Alpha in the Treatment of Oral Warts in HIV-Positive Patients
Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR)
today announced submission to the FDA of a protocol for a Phase II study to
test low-dose interferon alpha lozenges administered orally to human
immunodeficiency virus (HIV)-positive subjects with oral warts. 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 have been conducted and 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 III 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 on the East and West coasts have been contacted but
additional sites are being sought to help enroll 75 patients in a study in
which treatment will last 24 weeks. Interested investigators are urged to
contact Martin Cummins, Director of Clinical and Regulatory Affairs at
806-376-1741 ext. 14 or email: mcummins@amarbio.com. Patient enrollment
will begin in the third quarter of 2006.
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 15.5% 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, idiopathic pulmonary fibrosis, hepatitis B, myeloproliferative
diseases and opportunistic infections in patients who are HIV positive. In
its 22-year history, ABI has invested $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, 2004.
Newswire by Market Wire
Copyright © 2008, MarketWire
Copyright © 2008, NewsBlaze,
Daily News
Tags: ,Pharmaceuticals and Biotech:Biotech, ,OTCBULLB,OTCBULLB,TX,AMARILLO, TX
_ _Is your favorite bookmark site missing?
Ask for it.