AMARILLO, Texas, Aug. 22 /PRNewswire/ -- Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR) announces that its proprietary orally-administered
interferon-alpha has been granted orphan drug designation as a treatment of
papillomavirus warts in the oral cavity of HIV positive patients. Oral warts
are severe, chronic, debilitating and disfiguring with no existing
satisfactory treatment. Therapy consisting of surgery, freezing or cautery is
only partially effective. In contrast, Amarillo Biosciences' low dose orally-
administered interferon-alpha (Veldona(R)) has shown a preliminary indication
of effectiveness with minimal side effects in an initial clinical trial in a
major HIV treatment center in San Francisco. The oral formulation is
administered as a lozenge which is allowed to dissolve slowly in the mouth.
Oral dosing with interferon-alpha has a number of advantages over the
injectable form; in addition to substantially fewer side effects, the lozenge
is more convenient, cost effective and does not require refrigerated storage.
The orphan designation process is the mechanism by which sponsors of drugs
and biologics for rare diseases qualify for the tax credit and marketing
exclusivity incentives of the Orphan Drug Act. The Office of Orphan Products
Development also administers a clinical research grants program, whereby
researchers may compete for funding to conduct clinical trials to support the
approval of drugs for rare diseases. The US patient population with HIV and
persistent oral warts has been estimated at less than 5,000.
Amarillo Biosciences has been granted Orphan Drug status previously for
orally-administered interferon alpha for the treatment of Behcet's disease and
a meeting with FDA, regarding Behcet's disease, has been requested.
Dr. Joseph M. Cummins, CEO of Amarillo Biosciences stated, "We believe
that low dose orally-administered interferon-alpha has therapeutic benefit in
oral warts with a virtual absence of side effects."
Amarillo Biosciences, founded in 1984, is a pioneer in the development of
low dose orally-administered interferon-alpha as a treatment for a variety of
conditions including Sjogren's syndrome, Behcet's disease, hepatitis, and
opportunistic infections in patients who are HIV positive. ABI is conducting
a Phase III clinical program in Sjogren's syndrome in the United States and
plans to initiate a hepatitis C clinical trial in Egypt later this year. This
study will be conducted by Biopharm, Inc., ABI's commercial partner for the
middle East.
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
Dec. 31, 1999.
SOURCE Amarillo Biosciences, Inc.
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Related links:
http://www.amarbio.com
CONTACT:
Philip C. Fox, D.D.S., Director of Research &
Development of Amarillo Biosciences, Inc., 301-320-8200, or
pcfox@amarbio.com
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