AMARILLO, Texas, Feb. 1 /PRNewswire/ -- Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR) announced today that the Office of Orphan Drugs has
granted Orphan Drug status to its natural human lymphoblastoid interferon-
alpha for the treatment of Behcet's disease.
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. 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.
Behcet's disease is a severe chronic relapsing inflammatory disorder
marked by oral and genital ulcers, eye inflammation (uveitis), skin lesions,
as well as varying multisystem involvement including the joints, blood
vessels, central nervous system, and gastrointestinal tract. The oral lesions
are an invariable sign, occurring in all patients at some time in the disease.
Behcet's disease is found world-wide, and is a significant cause of partial or
total disability. The US patient population has been estimated as 15,000.
There are inadequate treatment options for patients with Behcet's disease.
Therapy is often only partially effective or carries the burden of serious
adverse effects. Injectable interferons have been shown to be beneficial in
the treatment of Behcet's disease, but exhibit numerous side effects, which
can be severe. In contrast, Amarillo Biosciences' low dose orally-
administered interferon-alpha (Veldona(R)) has been shown in clinical trials
to have minimal and mild side effects. 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 the substantially lower level of side effects, the lozenge is a
more convenient and cost effective route of administration, and lozenges do
not require refrigerated storage.
Amarillo Biosciences is planning a clinical development program to
commence later in 2000. Behcet's Disease is extremely debilitating for the
patient, with significant morbidity and mortality, and with few satisfactory
treatment options. Dr. Joe Cummins, CEO of Amarillo Biosciences stated, "We
believe that low dose orally-administered interferon-alpha will show real
therapeutic benefit in Behcet's disease with a virtual absence of side effect
liability."
Alex Knight, Chairman of Behcet Organisation Worldwide (BOW -
http://www.behcets.org) stated: "We at BOW support a number of Behcet's patients
reaching over 44 countries. By far the largest population of our constituency
reside in the United States. BOW is always in support of new medications that
bring rapid, pain free relief to our population, particularly those
medications with far lower side effects than current medications. We stand in
full support of Amarillo Biosciences and are deeply grateful for their work
and efforts on our behalf."
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, fibromyalgia syndrome, hepatitis B
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 has already enrolled approximately 400 of the targeted 500 subjects
in pivotal trials. The company is targeting an initial filing for regulatory
approval in Sjogren's syndrome by the end of this year. The Company is also
conducting a clinical trial testing oral interferon for the treatment of
fibromyalgia and 120 patients have been enrolled in a confirmatory Phase II
study.
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, 1998.
SOURCE Amarillo Biosciences, Inc.
 back to top
Related links:
http://www.behcets.org
Company News On-Call:
http://www.prnewswire.com/comp/118055.html or fax,
800-758-5804, ext. 118055
CONTACT:
Philip C. Fox, D.D.S., Director of Research &
Development of Amarillo Biosciences, Inc., 301-320-8200, or
email, pcfox@amarbio.com
|
