AMARILLO, Texas, April 28 /PRNewswire/ -- Amarillo Biosciences, Inc.
(Nasdaq: AMAR) today announced that enrollment has begun at three additional
study sites for its Phase II clinical trial to test low dose oral interferon
alpha (IFN alpha) in the treatment of fibromyalgia syndrome. Fibromyalgia is
a syndrome characterized by achy pain and stiffness in the soft tissues,
including the muscles, tendons and ligaments. The syndrome is estimated to
affect approximately 7.5 million Americans at a cost of $15 billion in support
payments (according to market research).
The three new researchers include Dr. Robert Bennett at the Oregon Health
Sciences University in Portland, Oregon, Dr. Stuart Kassan of the Colorado
Arthritis Associates in Denver, Colorado and Dr. Robert Katz of Rheumatology
Associates, S.C. in Chicago, Illinois. They join Dr. I. Jon Russell, a world
recognized leader in fibromyalgia research at the University of Texas Health
Science Center in San Antonio, Texas who has been enrolling patients into the
study since July 1998. The trial, which will ultimately randomize
120 patients, will conclude by the end of 1999.
"At present, there are no approved therapies for fibromyalgia," says Dr.
Philip C. Fox, Director of Research and Development at Amarillo Biosciences,
Inc., "and existing treatments are unsatisfactory. A safe and effective
therapy for this condition, with minimal side effects, would be of tremendous
benefit to the millions of individuals who suffer with the chronic symptoms of
fibromyalgia. That is the reason we have added these additional clinical
sties: to accelerate the completion of this exciting research."
All subjects will take low-dose amitriptyline at bedtime for a four-month
period. After the first month of treatment with amitriptyline, subjects will
be randomly assigned to either placebo or low dose oral IFN alpha.
Subjects will be evaluated monthly during the study using visual analogue
scale questionnaires to measure factors such as morning stiffness severity,
physical function ability and pain. Additional questionnaires such as the
Stanford Health Assessment Questionnaire will be administered at each visit.
Comprehensive information regarding morning stiffness will be gathered at the
beginning and end of the study using various techniques including specialized
questionnaires and body diagrams. Also, quantitative assessments of pain will
be performed at each evaluation. Quantitative assessment of pain severity and
muscle tenderness will be done also.
Founded in 1984, Amarillo Biosciences is a world leader in the development
of low dose oral interferon alpha as a treatment for a variety of conditions
including Sjogren's syndrome, fibromyalgia syndrome, hepatitis B and
hepatitis C. ABI has ongoing human clinical protocols for each of these
conditions. Low dose interferon has numerous benefits over high dose
injectable interferon, including fever and milder side effects, greater cost
effectiveness and convenient oral dosing.
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. The
Description of Business" of the company's Form 10-KSB for the year ended
Dec. 31, 1998.
SOURCE Amarillo Biosciences, Inc.
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http://www.amacell.com
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http://www.prnewswire.com/comp/118055.html or fax,
800-758-5804, ext. 118055
CONTACT:
Kathleen L. Kelleher, COO and Vice
President-Business Development of Amarillo Biosciences, Inc.,
806-376-1741, or email, ABI@AmarBio.com
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