AMARILLO, Texas, Jan. 5 /PRNewswire/ -- Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR.OB) (ABI) announces the completion of the Company's
second phase III clinical trial in primary Sjogren's syndrome. Sjogren's
syndrome is an autoimmune connective tissue disorder which affects between 1
and 2 million people in the United States and a similar number in Europe.
Sjogren's syndrome patients characteristically suffer from dry mouth and eyes.
Dry mouth frequently compromises the oral health of these patients and makes
it difficult to eat and talk. Increasing natural saliva production is a
treatment goal in Sjogren's syndrome patients.
The phase III clinical trial was a double-blinded, placebo-controlled
study in which 256 patients were treated three times daily with a lozenge
containing either 150 International Units of natural interferon alpha (IFN-a)
or with a placebo for 24 weeks. An improvement in saliva production was noted
in the group given IFN-a. This result was similar to that seen in the initial
phase III study which utilized the same protocol. The most robust increases
were noted in unstimulated whole saliva (UWS) production, with the IFN-a
treated patients who completed the entire 24 weeks demonstrating more than
2 times the increase of the placebo group. Increases in stimulated whole
saliva (SWS) and improvement in a number of subjective measures of dry mouth
also favored the IFN-a group. There were highly significant correlations
between improvements in UWS and SWS at 24 weeks and between increased UWS and
improvement in oral symptoms in the IFN-a treated patients, including oral
dryness (p=0.001), oral comfort (p=0.03), the ability to swallow dry food
(p=0.003), the ability to swallow any food (p=0.001) and throat dryness
(p=0.03). Significant correlations between these measures were not found in
the placebo group.
In study patients (68% of those enrolled) who had circulating
autoantibodies, a frequent finding in patients with Sjogren's syndrome, there
was a significantly greater improvement in UWS in the IFN-a group compared to
placebo at the conclusion of the trial (p=0.03). This finding is important in
that the presence of one or more autoantibodies is likely to have increased
importance in the diagnosis of Sjogren's syndrome in the future.
The Company plans to discuss these findings, in addition to the combined
results of the phase III clinical studies, with the FDA during an upcoming
teleconference. When results from the two identical phase III trials are
combined, significant increases in UWS are found at the 24 week time point in
the IFN-a treated patients compared to controls (p=0.0134). Moreover
increases from baseline in UWS within the IFN-a group were highly significant
(p=0.0005). Patients within the IFN-a treated group also had significant
(p=0.0001) improvement from baseline in symptoms of oral dryness, oral comfort
and throat dryness. The improvement in these and other symptoms was highly
correlated with changes in both the UWS and SWS.
"The finding of an increase in UWS is particularly important for patients
with Sjogren's syndrome, as UWS represents the baseline production of saliva
that patients experience throughout the day," said Joseph M. Cummins,
President and CEO for Amarillo Biosciences. "The UWS is of paramount
importance in maintaining a healthy mouth and oral comfort. We believe that
increases in UWS may be the result of improvement in the underlying gland
function and salivary pathology of this disorder. This suggests that IFN-a is
more than a symptomatic treatment in Sjogren's syndrome; it addresses the
underlying secretory dysfunction. If proven, IFN-a will represent a true
advance in therapeutic options for this condition."
As revealed in our news release of April 7, 2000, measurements of
stimulated whole saliva and subjective oral dryness were the primary end
points of the study. When an intent-to-treat analysis was used to analyze the
data, which includes all randomized patients regardless of whether they
completed the full trial, the results were not significant. Further clinical
trials will focus on examining histopathological improvements in labial minor
salivary glands as a result of low dose natural IFN-a treatment.
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.amarbio.com
Company News On-Call:
http://www.prnewswire.com/comp/118055.html or fax,
800-758-5804, ext. 118055
CONTACT:
Joseph M. Cummins, President & CEO,
806-376-1741 ext. #13, or jcummins@amarbio.com, or Kathleen L.
Kelleher, COO & VP Business Development, 806-376-1741 ext. #15,
or kkelleher@amarbio.com, both of Amarillo Biosciences, Inc.
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