Natural Interferon Alpha Boosts Saliva Production In Patients With Sjogren's Syndrome

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Natural Interferon Alpha Boosts Saliva Production In Patients With Sjogren's

Syndrome

AMARILLO, TX -- January 5, 2001 -- Amarillo Biosciences, Inc. (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 one and two 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 percent 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 ph 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 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.