AMARILLO, Texas, April 7 /PRNewswire/ -- Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR)/(ABI) has completed the first 24 week Phase III
clinical trial of the use of oral interferon alpha (IFNalpha) in primary
Sjogren's syndrome, the second most common autoimmune connective tissue
disorder. Sjogren's syndrome affects between 1 and 2 million people in the
United States and a similar number in Europe.
Patients with the disease generally suffer from dry mouth and eyes, and
oral symptoms are frequently so severe that sufferers find it difficult to eat
and talk. More information about this disease condition can be found on the
National Institute of Dental and Craniofacial Research web site
(http://www.nidr.nih.gov).
Results of ABI's Phase III clinical trial demonstrated an improvement in
saliva production. The study was a double-blinded, placebo-controlled test in
which 241 patients were treated three times daily for 24 weeks with a lozenge
containing either 150 International Units of IFNalpha or a placebo. Analysis
of participants who completed the trial, designated as evaluable patients,
found a significant increase in unstimulated whole saliva (UWS) production
among the IFNalpha treated patients, as compared to those who received
placebos. As expected, this increase correlated strongly with subjective
improvements in oral dryness, throat dryness and nasal dryness, as determined
by visual analogue scales.
"A measurement of UWS represents the baseline production of saliva which
patients experience throughout the day," said Dr. Philip C. Fox, Director of
Research and Development for Amarillo Biosciences. "The UWS is of paramount
importance in maintaining a healthy mouth and oral comfort. Any increase in
UWS is expected to result in relief of symptoms of dryness, as seen in this
study and an improvement in oral health."
Also in the evaluable patient group, IFNalpha treated subjects had
significant correlations between increases in stimulated whole saliva and an
easing of symptoms, including oral dryness, throat dryness and the ability to
swallow foods.
Measurements of stimulated whole saliva and subjective oral dryness had
been designated the primary end points of the study. When an evaluable
analysis or an intent-to-treat analysis -- one including all participants,
even those who didn't complete the study -- was used to analyze these data,
the results were not significant. The FDA typically requires that statistical
significance be achieved using an intent-to-treat analysis in order to achieve
regulatory approval.
Because of the importance of the UWS measurement, not only in this study
but also to the general health of Sjogren's syndrome patients, the Company
plans to focus on this measure in its second, ongoing Phase III study of an
additional 250 patients. The Company intends to revise the primary end point
of the study to be the change in unstimulated whole saliva, but will continue
to measure all end points. The second stage Phase III trial will be completed
late in 2000.
Amarillo Biosciences, founded in 1984, is a pioneer in the research 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, C, and opportunistic infections in patients who are HIV
positive.
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.nidr.nih.gov
http://www.amacell.com
Company News On-Call:
http://www.prnewswire.com/comp/118055.html or fax,
800-758-5804, ext. 118055
CONTACT:
Kathleen Kelleher, Chief Operating Officer,
806-376-1741, ext. 15, or email, kkelleher@amarbio.com, or Philip
C. Fox, D.D.S, Director of Research & Development, 301-320-8200,
or email, pcfox@amarbio.com, both of Amarillo Biosciences, Inc.
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