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Interferon alpha Therapy for the Treatment of Idiopathic Pulmonary Fibrosis - Study
May 25, 2005, 11:47, Reviewed by: Dr.
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"There exists a low level of interferon in the lungs of IPF patients. IFNa is known to stimulate the body's interferon production; modify immune responses; prevent activation of fibroblasts and deposition of collagen (scarring process); and, activate aquaporins in lungs, thereby preventing drying of the tissue across which oxygen enters the blood."
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By Amarillo Biosciences, Inc.,
Amarillo Biosciences, Inc. (ABI) (OTC BB: AMAR) today announced that the Company has been supplying its low-dose orally administered interferon alpha (IFNa) to a pilot clinical trial in the treatment of idiopathic pulmonary fibrosis (IPF).
The study, is being conducted by Lorenz O. Lutherer, M.D., Ph.D. and Cynthia Jumper, MD, Professors of Internal Medicine at Texas Tech University Health Sciences Center. 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.
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, and current treatments are ineffective.
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.
"IFNa was selected as a potentially effective therapy for IPF for a number of reasons," stated Dr. Lutherer. "There exists a low level of interferon in the lungs of IPF patients. IFNa is known to stimulate the body's interferon production; modify immune responses; prevent activation of fibroblasts and deposition of collagen (scarring process); and, activate aquaporins in lungs, thereby preventing drying of the tissue across which oxygen enters the blood."
The study has enrolled 17 of 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 (HRTC) annually.
Results to date suggest that while IFNa treatment has not reversed existing damage, it appears to be arresting the progression of the disease, and the duration of the stability is impressive given the short expected survival time after diagnosis. The stability -- arrest of IPF -- was confirmed by pulmonary function tests in 6 of 7 patients treated at least 1 year, including one subject who has been on IFNa treatment for three years. "Subjects also experienced a marked decrease in cough and have expressed a positive response to the lack of progression of the disease," stated Dr. Lutherer.
Accordingly, ABI, in conjunction with Dr. Lutherer, will continue to follow those 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. Dr. Lutherer will present his findings and answer questions at the ABI Annual Shareholder's Meeting on May 27th. 
- U.S. Food and Drug Administration (FDA)
www.amarbio.com
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc., is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 20.6% of Amarillo Biosciences shares and has provided over $16.5 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, Beh�et's disease, and opportunistic infections in patients who are HIV positive. In its 20-year history, ABI has invested nearly $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.
Investor Relations:
Philippe Niemetz
WPH Consultants, Ltd.
Tel: 800-477-7570
Tel: 212-344-6464
Fax: 212-618-1276
e-mail: [email protected]
Joseph M. Cummins, DVM, PhD
Amarillo Biosciences, Inc.
Tel: 806-376-1741 x13
Fax: 806-376-9301
e-mail: [email protected]
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