AMARILLO, Texas, June 2 /PRNewswire-FirstCall/ -- Amarillo Biosciences,
Inc. (OTC Bulletin Board: AMAR), a leading U.S. pharmaceutical research and
development firm, is taking new steps to help combat the spread of Severe
Acute Respiratory Syndrome (SARS) in Asia. The Company has named Dr. Stephen
Chen, President of STC International in East Brunswick, NJ, as its exclusive
agent in China and Taiwan to introduce and distribute low-dose oral interferon
alpha lozenges for use in the treatment and prevention of SARS.
World health officials currently believe SARS may have evolved in China
from an animal coronavirus that was then transferred into the human
population. Fortunately, past research studies by Amarillo Biosciences have
determined that low-dose, orally delivered human interferon alpha can
significantly reduce mortality in piglets undergoing a natural outbreak of an
animal coronavirus, named TGE (transmissible gastroenteritis) virus. This has
raised hopes that a similar treatment regimen may prove equally effective in
combating SARS in humans.
Massive injections or IV applications of interferon (known as parenteral
treatment) have been successfully used to fight other human viruses, but this
approach is expensive and much too toxic for use against a widespread disease
such as SARS. By contrast, orally delivered human interferon alpha can be
easily and inexpensively used to modulate the immune system in a non-toxic
way, as demonstrated by Amarillo Biosciences' published (Vet Immunology
Immunopathology 45: 355-360, 1995) study involving TGE-infected swine. In
that study, a total of 1,740 piglets were given either a placebo or a natural
human interferon alpha dose at 1, 10 or 20 IU per animal. Positive results
were achieved at all dosage levels, but the greatest survival benefit involved
use of 20 IU doses administered once daily for four days -- i.e., the survival
rate in infected piglets 1-12 days of age rose from 15% in placebo-treated
controls to 50% in interferon-treated animals.
This result mirrors other findings by Amarillo Biosciences, which has done
extensive R&D into orally delivered cytokines over the past 19 years, studying
the use of oral interferon in dogs, cats, horses, cattle, swine, poultry,
mice, rats, monkeys, guinea pigs and humans. The earliest applications of
oral interferon were in cattle with viral respiratory infections, cats with
respiratory infections or with leukemia and dogs with canine parvovirus.
Since going public in 1996, the Company has focused on human clinical trials
conducted in patients with fibromyalgia, aphthous stomatitis, Sjogren's
syndrome, the common cold, hepatitis B, chronic fatigue syndrome and AIDS.
These double-blinded, placebo-controlled clinical trials, which involved
1,504 human patients, have shown the Company's interferon lozenges to have an
outstanding safety record, with the most common side effect being headaches.
However, headache occurred in only 6.3% of interferon-treated patients as
compared to 6.0% of placebo-treated patients.
Amarillo Biosciences' interferon lozenges are produced by the Company's
partner, Hayashibara Group, which was founded in 1883 and is now Japan's
second-largest pharmaceutical and bio-tech company, consisting of
15 corporations and two non-profit foundations. One of those corporations,
Hayashibara Biochemical Laboratories, Inc (HBL), of Okayama, has been
performing R&D involving the manufacture and use of interferons since 1970,
and has gained Japanese regulatory approval to market HBL's natural human
interferon alpha for the parenteral treatment of renal cell carcinoma, chronic
active hepatitis B and C, chronic myelogenous leukemia and chronic non-active
hepatitis C. Since 1989, Amarillo Biosciences and HBL have been working
together to develop low-dose orally delivered interferon alpha.
As a result of its research, Amarillo Biosciences has earned 18 patents
(with two more pending), issued with claims for the use of oral interferon in
treatment of many diseases, including viral infections. One of the more
recent patents relates to the formulation of the interferon lozenges, which
are foil-wrapped and remain stable at room temperature for at least 24 months.
The lozenges are thus inexpensive, stable for long periods, easy to
administer, and have demonstrated efficacy, making them an ideal product for
the treatment of SARS.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc., is a cutting-edge U.S. biotechnical firm
operating in global partnership with the Hayashibara Group, Japan's second-
largest pharmaceutical company, which also holds 36.5% 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 Amarillo
Biosciences, Inc. 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:
Dr. Joseph M. Cummins, President & CEO of
Amarillo Biosciences, Inc., +1-806-376-1741 ext. 24, or
jcummins@amarbio.com
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