Healthcare Industry News: Sjogren's syndrome
News Release - March 6, 2006
Amarillo Biosciences Reports on Clinical Trial of Oral Interferon Therapy in Idiopathic Pulmonary FibrosisResults Presented at the Southern Regional Meeting of the Society for Clinical Investigations
AMARILLO, TX--(Healthcare Sales & Marketing Network)--Mar 6, 2006 -- Amarillo Biosciences, Inc. (ABI) (OTC BB:AMAR.OB ) today announced that Lorenz O. Lutherer, M.D., Ph.D. and Cynthia Jumper, MD, Professors of Internal Medicine at Texas Tech University Health Sciences Center, presented data in Atlanta at the Southern Regional Meeting of the Society for Clinical Investigations on low-dose orally-administered interferon alpha (IFNa) as a treatment for idiopathic pulmonary fibrosis (IPF). The study, which commenced 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 ABI.
IPF 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.
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. Originally designed for one year, subsequent FDA approval was obtained to continue the IFNa treatment in those subjects who demonstrate stabilization of IPF. The subjects are evaluated with pulmonary function tests quarterly and chest x-rays and high resolution computed tomography (HRCT) annually.
In his presentation, Dr. Lutherer concludes the following:
1) Treatment with low-dose, orally-administered IFNa was well tolerated by IPF patients with no side effects reported.
2) Preliminary retrospective data strongly suggest that this regiment in most subjects leads to a rapid and significant reduction in the cough associated with IPF, resulting in an improvement in the quality of life.
3) All subjects had severely compromised lung function on study entry. Most of the ten subjects treated for a 12-month period had stable or minimally progressive disease. Two subjects, still under treatment, have shown no disease progression over 24 and 48 months, respectively.
4) 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.
5) 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 IPF. This drug should be compared with other therapeutic approaches in larger trials.
Accordingly, ABI, in conjunction with Dr. Lutherer, will continue to follow those patents on treatment; use current data to apply for Orphan Drug Designation from the Food and Drug Administration (FDA); and, submit a Phase II development program to FDA.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc., is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 17% of Amarillo Biosciences shares and has provided over $17.8 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D 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. In its 21-year history, ABI has invested $37 million to establish oral interferon as a therapeutic agent. The overwhelming majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the ABI web site at http://www.amarbio.com/.
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 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 December 31, 2004.
Source: Amarillo Biosciences
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