AMARILLO, Texas, Oct. 14 /PRNewswire-FirstCall/ -- Amarillo Biosciences,
Inc. (OTC Bulletin Board: AMAR) (ABI) today announced filing of an IND
application for a pivotal Phase III trial 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 study demonstrates the efficacy of
safety of this treatment regimen, ABI intends to file 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 coast and West coast have been contacted but
additional sites are being sought to help enroll 90 patients in a study which
will last 32 weeks. Potential clinical sites are urged to contact Martin
Cummins, Director of Clinical and Regulatory Affairs at 806-376-1741 xt22 or
email: mcummins@amarbio.com. Patient enrollment will begin in the first
quarter of 2004.
The FDA's Office of Orphan Products Development 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 32% of
Amarillo Biosciences shares. The Company's primary focus is extensive and
ongoing R&D into the use of low-dose, orally administered interferon alpha as
a treatment for a variety of conditions, including Sjogren's syndrome,
fibromyalgia syndrome, Behcet's disease, hepatitis B and C, and opportunistic
infections in patients who are HIV positive. 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 alpha 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, 2002.
SOURCE Amarillo Biosciences, Inc.
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Related links:
http://www.amarbio.com
Company News On-Call:
http://www.prnewswire.com/comp/118055.html
CONTACT:
Philippe Niemetz of WPH Consultants, Ltd.,
+1-800-477-7570, or +1-212-344-6464, or fax, +1-212-618-1276, or
philippe.niemetz@wphconsultants.com , for Amarillo Biosciences,
Inc.
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