Amarillo: Interferon lozenges reduce cough, improve life of idiopathic pulmonary fibrosis patients

By E. Janene Geiss

Philadelphia, March 6 - Amarillo Biosciences, Inc. announced Monday that data from a study of low-dose orally administered interferon alpha (IFNa) as a treatment for idiopathic pulmonary fibrosis showed the treatment was well-tolerated with no side effects, reduced patients' cough and improved their quality of life.

The study has enrolled 20 planned subjects who are being administered 150 units of IFNa three times daily in the form of orally dissolving lozenges, according to a company news release.

Originally designed for one year, subsequent FDA approval was obtained to continue the IFNa treatment in those subjects who demonstrate stabilization of the disease.

The subjects are evaluated with pulmonary function tests quarterly and chest x-rays and high resolution computed tomography annually. Results of the study included:

• The treatment was well tolerated with no side effects reported;

• Preliminary retrospective data strongly suggest that this regiment in most subjects leads to a rapid and significant reduction in the cough associated with the disease, improving quality of life;

• Most of the 10 subjects, which had severely compromised lung function on study entry, had stable or minimally progressive disease after being treated for a 12-month period. Two subjects, still under treatment, have shown no disease progression over 24 and 48 months, respectively; and

• Each of the subjects served as their own control and there was no placebo control group for comparison. However, given the well-documented rapid rate of progression and the short life expectancy after diagnosis, stability over this long period of time in this high percentage of subjects strongly suggests potential efficacy of this treatment regimen, officials said.

Treatment with low-dose, orally administered IFNa may be an inexpensive, non-invasive and safe approach to preventing or decreasing the rate of further deterioration of lung function in patients with idiopathic pulmonary fibrosis. This drug should be compared with other therapeutic approaches in larger trials, officials said.

The study, which began in 2001 and is ongoing, was funded by a grant from the State of Texas Higher Education Coordinating Board, Applied Technology Program. The IFNa lozenges are being supplied by Amarillo.

Results of the study were presented by Lorenz O. Lutherer and Cynthia Jumper, professors of Internal Medicine at Texas Tech University Health Sciences Center, in Atlanta at the Southern Regional Meeting of the Society for Clinical Investigations.

Idiopathic pulmonary fibrosis is a lung disease of unknown origin that causes scarring of lung tissue, which in turn leads to difficulty in supplying oxygen into the blood stream. The disease is relatively rare, with an incidence of 20 per 100,000. The disease's symptoms include the gradual onset of a persistent cough, difficulty breathing, a progressive inability to perform physical activities, changes in lung function tests and a marked decrease in the quality of life. The prognosis is a limited expected life span of 3.2 to 5 years after diagnosis.

Amarillo said it will continue to follow patients on treatment and use current data to apply for orphan drug designation from the Food and Drug Administration. The company said it also plans to submit a phase 2 development program to the FDA.

Amarillo Biosciences is an Amarillo, Texas, biotechnology company operating in partnership with the Hayashibara Group, which also holds 17% of Amarillo Biosciences shares and has provided more than $17.8 million in loans, grants and equity investments. The company's primary focus is extensive and ongoing research and development into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including Sjogren's syndrome, Behçet's disease, and opportunistic infections in patients who are HIV positive.

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