Company Files an Investigative New Drug (IND) Application With FDA on Behcet's
Disease and Announces Plans for IND Applications in Other Clinical Areas
AMARILLO, Texas, Dec. 3 /PRNewswire-FirstCall/ -- In October 1989,
Hayashibara Biochemical Laboratories (HBL) and Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR) (ABI) entered into a license/supply agreement for
oral interferon alpha, thereby beginning a business collaboration to seek FDA
approval for interferon. In the intervening 15 years, interferon has been
given to over 4,000 human patients in 55 studies. Over 20 patents have been
filed and 16 are currently issued on the oral interferon technology.
There are now more than 200 publications on the subject of orally
administered interferon. An extensive review article on the systemic effects
of orally administered interferon was prepared by the Company and will be
published in January 2005.
In its 20-year history, ABI has invested nearly $37 million to establish
interferon as a therapeutic agent for a number of diseases. The overwhelming
majority of those funds were invested in clinical trials in an effort to
achieve FDA approval for interferon. Concurrently, HBL has been steadfast in
its support of ABI, and has provided over $16.5 million in loans, grants and
equity investment.
ABI remains optimistic that FDA approval for interferon lozenges can be
achieved. Interferon, in an oral formulation, is a non-toxic, inexpensive,
easy-to-administer product that provides benefits and relief to many people
suffering from a multiplicity of afflictions.
The FDA has granted ABI Orphan Drug Designations (ODDs) for oral warts in
HIV+ patients, Behcet's Disease and polycythemia rubra vera (PRV). FDA grants
the ODDs for diseases that affect fewer than 200,000 patients. The benefits
of ODDs are: a) the company enjoys 7 years exclusivity in the marketplace;
b) tax credits equal to 50% of clinical trial costs; and c) FDA user fees may
not apply.
ABI filed an IND application in October 2004 for a 90 patient study on
patients with Behcet's Disease. This study will be conducted in Istanbul in
cooperation with Nobel Ilac, a licensee of ABI (see news release dated
September 14, 2004). All comments from the FDA are expected by mid-December
after which time the documents supporting the IND application will be
submitted to the Ministry of Health in Turkey. It is our goal to enroll the
first patients to receive oral interferon in the first quarter of 2005. It
should be noted that Behcet's Disease is 600 times more prevalent in Turkey
than in the United States, hence the interest from Turkey and the reason that
the clinical trials are being conducted there.
In November 2004, a group of oncologists approached ABI in order to
conduct oral interferon studies in patients with pre-leukemia conditions
called essential thrombocythemia (ET) (too many platelets) or polycythemia
rubra vera (PRV). A few years ago, ABI conducted a pilot study on patients
with ET or PRV and noted that oral interferon, at the dosage then tested,
provided some benefit and relief. One of ABI's goals is to follow-up the
pilot study with an expanded study in partnership with a renowned cancer
center in Texas. ABI intends to file an IND application on ET and PRV in
January 2005.
The World Health Organization has recently issued a dire prediction that
the bird flu virus could kill up to 100 million people around the world. More
than 30 years ago, a number of European human clinical trials found that
interferon administered intranasally in small doses prevented or reduced
symptoms of influenza. The dose typically given was less than 1,000 IU per
day. The Company believes that low dose oral interferon is affordable,
whereas just about every other antiviral drug is too expensive for use in the
developing world. ABI's interferon lozenges are stable at room temperature
for 2 years. Human clinical testing in various diseases has shown that the
interferon lozenges are non-toxic, easy-to-administer, and exert systemic
beneficial effects.
The idea of using low doses of interferon has been largely ignored, as
clinicians have adopted the "more is better" philosophy. A careful review of
the literature, including our own soon-to-be-published interferon review
entitled "Systemic effects of interferons after oral administration in animals
and humans" will hopefully motivate a re-examination of the delivery of low-
dose oral or nasal interferon as a therapy for influenza.
In 1957, the name "interferon" was given to a substance isolated from
chicken eggs that interfered with the replication of influenza virus.
Accordingly, it seems logical to explore the use of oral interferon as an
inexpensive way to help save lives in the next influenza pandemic.
We continue to work with representatives of the agro-business giant
Cargill to stimulate interest in our oral interferon to control the virus that
causes foot-and-mouth disease (FMD). We are trying to motivate US government
officials to consider oral interferon as an economic alternative to the
slaughter of livestock if FMD virus is introduced in the USA.
We expect that funding for our FDA approval effort for interferon lozenges
will come from: 1) license fees for ABI's low dose interferon; 2) sales of our
dietary supplement; and, 3) sales of oral interferon for animal health. We
expect to report to you on our progress in the coming months.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc., is a U.S. biotechnology firm operating in
global partnership with the Hayashibara Group, which also holds 24% of
Amarillo Biosciences shares. 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.
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,
2003.
SOURCE Amarillo Biosciences, Inc.
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Related links:
http://www.amarbio.com
CONTACT:
investor relations, 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.; or Joseph M. Cummins, DVM, PhD of
Amarillo Biosciences, Inc., +1-806-376-1741 ext. 13, or fax,
+1-806-376-9301, or jcummins@amarbio.com
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