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Low-Dose Interferon Lozenges HCV & HIV/oral warts Study
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Amarillo Biosciences Issues Clinical Trials Update
AMARILLO, Texas--(BUSINESS WIRE)--Amarillo Biosciences, Inc. (ABI) (OTCBB:AMAR) today announced the following developments:
In Turkey, enrollment is 86% complete in a Phase 2 study of Behcet's disease. In the United States, four new clinical sites have been opened to enroll patients in a Phase 2 clinical trial of oral warts. In Texas, enrollment will begin in October 2007 to test oral interferon as a treatment of chronic cough in COPD (chronic obstructive pulmonary disease) patients. In Australia, a human influenza study is planned in 2008. In Taiwan and China, ABI's Taiwanese partners are expected to conduct a clinical trial in chronic active hepatitis C patients. These developments will help pave the way for the realization of the company's ultimate goal: FDA approval for its low-dose oral interferon.
Behcet's Disease Double-Blinded, Placebo-Controlled Phase 2 Clinical Trial
Enrollment in Turkey for Behcet's disease currently stands at 77 patients. Ninety patients are required in order to complete the Phase 2 clinical trial. Enrollment is expected to be completed in the fall of 2007, and data analysis will begin approximately 12 weeks after the last patient is enrolled. The company's Turkish partner Nobel Ilac, one of the largest pharmaceutical companies in Turkey, is funding the study. Nobel Ilac may be able to use the Phase 2 data to seek approval in Turkey, assuming the data are compelling.
Oral Warts Double-Blinded, Placebo-Controlled Phase 2 Clinical Trial
A Phase 2 clinical trial is testing low-dose interferon alpha lozenges administered orally to subjects who have oral warts and are also positive for human immunodeficiency virus (HIV). Viral lesions of the mouth in patients infected with HIV are common and may be indicative of disease progression. One of the causes of oral lesions is an oral infection with the wart-producing papillomavirus.
Twelve clinical sites in San Francisco, Baltimore, Chicago, New York City, Boston, Philadelphia, Newark, Dallas, Augusta (GA), Ft. Lauderdale, San Antonio and Lexington (KY) are open for enrollment of patients for this study. To date, 26 of 80 patients have been enrolled. Enrollment is expected to accelerate rapidly now that all twelve sites have been approved.
CytoPharm Plans for Hepatitis C Clinical Trial
The company's licensee in Taiwan and China is CytoPharm, Inc., a Taipei, Taiwan-based biopharmaceutical company whose parent company is Vita Genomics, Inc., the largest biotech company in Taiwan specializing in pharmacogenomics and specialty Clinical Research Organization. Both CytoPharm and Vita Genomics are affiliates of Ho Tung Chemical Corp. Ltd., one of the largest petrochemical companies in Taiwan, and a publicly traded company.
Under the terms of the Agreement, between CytoPharm and ABI, CytoPharm and its subsidiary will conduct and fund all clinical trials, and seek regulatory approvals in both China and Taiwan (the Territory) to launch low-dose oral interferon for influenza, hepatitis B, and hepatitis C indications. CytoPharm has entered into discussions with regulatory agencies in the Territory to conduct their first clinical trial in 152 hepatitis C patients. The trial is expected to commence in early 2008.
Texas Tech University Idiopathic Pulmonary Fibrosis and COPD Studies
A total of 18 patients were enrolled in the past five years in a long-term pilot study of the use of interferon lozenges in the treatment of idiopathic pulmonary fibrosis (IPF) at Texas Tech University. Dr. Lutherer, the principal investigator of the study, reported that more than half of his patients treated for at least one year showed no signs of disease progression as assessed by pulmonary-function testing and high-resolution CT scans of their lungs. IPF is normally rapidly progressive, so the fact that half of the patients have shown no progression of the disease during interferon lozenge treatment is encouraging. These clinical results are being submitted for publication to a major medical journal.
The most surprising observation from the IPF research was that low-dose oral interferon relieved chronic coughing in five of six IPF patients assessed for cough in this study. Since chronic coughing is a major problem in Chronic Obstructive Pulmonary Disease (COPD), a Phase 2 clinical study of oral interferon treatment of chronic cough in COPD will begin this month. COPD is reported to affect 10% of humans over the age of 40.
Federal Funding
Amarillo Biosciences retained Hance, Scarborough, Wright, Woodward & Weisbart, an Austin-based law firm, to represent ABI regarding federal governmental and private source funding for influenza studies. The company is working to obtain federal funding for clinical trials on influenza to be conducted in 2008. University institutions such as the Texas Tech University Health Sciences Center would conduct these trials. Beyond these efforts to procure federal funding, the company seeks investor funding so that it can complete its clinical studies.
Influenza
Animal trials were conducted in 2006/2007 in Australia, USA and Germany, and are continuing in Germany. An oral dose of interferon was found, which protected mice against a fatal influenza challenge. A human trial is planned for the upcoming cold/flu season in Perth, Australia in July-October 2008.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 12% of Amarillo Biosciences' shares and has provided over $17.9 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, Behcet's disease, and opportunistic infections in patients who are HIV positive. In its 23-year history, the company has invested nearly $38 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available 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, 2006.
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