Amarillo Biosciences to Initiate Low-Dose Interferon Clinical Trials to Treat COVID-19, Appoints Interferon Specialist Dr. Manfred Beilharz to Scientific Advisory Board
Amarillo, TX - (NewMediaWire) - September 10, 2020 - Amarillo Biosciences, Inc. (“ABI” or the “Company”), (AMAR), the world leader in low-dose non-injectable interferon research, is pleased to announce the appointment of Dr. Manfred Beilharz, Associate Professor at The University of Western Australia and renown pioneer in interferon research, to the Company’s Scientific Advisory Board.
Based on the Company’s past successful clinical research using low-dose interferon, Dr. Beilharz will work closely with ABI and its research collaborators in initiating several clinical trials this year. These trials will primarily be focused on developing a therapeutic for COVID-19, as well as the continuation of the Company’s late-stage treatments for thrombocytopenia and Sjögren’s syndrome. ABI Chairman & CEO, Dr. Stephen T. Chen, remarked, “We are excited to be working again with Dr. Beilharz who has contributed tremendously to the interferon research field and there is a high degree of confidence that our non-injectable interferon development program, Veldona, will prove to be an effective therapeutic for these targeted indications based on supporting clinical research.”
In relation to COVID-19, clinical data has shown low-dose interferon alpha effective against other coronaviruses such as H1N1 and SARS. Previously, a published study for a collaborative phase 2b influenza trial conducted by Dr. Beilharz, “Low-dose oral interferon alpha as prophylaxis against viral respiratory illness: a double-blind, parallel controlled trial during an inﬂuenza pandemic year” demonstrated 150 IU interferon alpha delivered orally with ABI’s proprietary formulated Veldona lozenge significantly reduced the severity of symptoms in males aged 50 years or more and showed potential to enhance vaccine-induced protection against influenza. Other published clinical and non-clinical studies confirm low-dose interferon’s unique mechanism of action provide the medical-scientific rationale for ABI’s clinical development strategy for Veldona. Applying clinical studies towards COVID-19 is a logical next step.
Dr. Beilharz has stated, “The current COVID-19 pandemic urgently requires prevention and treatment options, particularly for frontline medical staff and at-risk groups, and oral low-dose type 1 interferon is a readily available public health option with an extensive published literature. It’s exciting that in the Hubei Province in China, where this pandemic originated, they have released details of a study where they treated over 2,000 frontline medical workers with oral interferon nose drops to try and protect them. There have been no reports of any contracting COVID-19, while in the controls - another 2,000 nurses and doctors working in the same province - 50 to 60 per cent were infected with COVID-19. That is a pretty clear demonstration of the prophylactic value of this.” Dr. Beilharz will be managing the Company’s COVID-19 clinical trials in Australia.
ABI is also preparing to resume its clinical trials for thrombocytopenia, an immune condition causing low platelet count prevalent in patients that experience hepatitis-C relapse and other debilitating conditions such as chemotherapy treatment. In a 2014 published study, “A Double-Blind Randomized Controlled Study to Evaluate the Efficacy of Low Dose Oral Interferon-Alpha in Preventing Hepatitis C Relapse,” Dr. Chau-Ting Yeh, Director, Liver Research Center at Chang Gung Memorial Hospital (Taiwan), was the co-author and principal investigator for a phase 2 clinical trial in which it was discovered that 500 IU low-dose interferon alpha was surprisingly effective in exerting a significantly expedited recovery of platelet count in chronic hepatitis C patients having moderate to severe liver fibrosis. As a result of this study ABI applied for and received four thrombocytopenia related patents. Dr. Yeh will be managing the Company’s subsequent thrombocytopenia clinical trials in Taiwan.
“As we move forward with planned Veldona clinical trials, both Dr. Beilharz and Dr. Yeh’s decades of research experience will be critical in successful execution and the establishment of effective collaborations with other stakeholders. Our goal will be to diligently advance the Veldona clinical trial program with the vision of developing Veldona-based new treatments for COVID-19 patients, as well as patients with difficult-to-treat indications like thrombocytopenia and autoimmune disorders such as Sjögren’s syndrome who are in urgent need for therapeutic solutions,” said Dr. Stephen T. Chen. About Dr. Manfred Beilharz
A leader in interferon research, Dr. Beilharz has extensive knowledge of type-1 interferons in relation to diseases of viral, autoimmune and neoplastic origin, as well as principal investigator experience in numerous interferon research studies including previous collaboration with ABI in an oral low-dose interferon alpha “Winter Colds and Flu” phase IIb clinical trial in Perth, Western Australia (2008-2010). Dr. Beilharz serves on the scientific advisory boards of US and Australian Biotech companies, consults widely, and is on the editorial board of the “Journal of Interferon and Cytokine Research.” He has worked full time in biomedical research since 1982 holding posts at Monash University, the University of Western Australia, Johns Hopkins University, Oxford University and the Australian Neuromuscular Research Institute.
About Dr. Chau-Ting Yeh
Dr. Yeh is currently a Director of the Liver Research Center at Chang Gung Memorial Hospital and is a leading researcher in hepatology with extensive experience in molecular biology and treatment of hepatitis B and hepatitis C, Hepatocarcinogenesis and marker-guided anticancer treatment. His ground-breaking research publication “Efficacy of Low Dose Oral Interferon-alpha in Preventing Hepatitis C Relapse” was instrumental in ABI obtaining its current patents related to thrombocytopenia. Dr. Yeh has an M.D. from National Taiwan University, Medical School and Ph.D. from USC, Department of Internal Molecular Microbiology and Immunology. He has received numerous awards including Distinguished Research Faculty Member, Chang Gung University (2012) and Taiwan Ministry of Science & Technology, FutureTech Demo and Breakthrough Award (2019).
About Amarillo Biosciences, Inc. Amarillo Biosciences, Inc. (ABI) is a diversified healthcare company engaged in the discovery and development of pharmaceutical and biotech products. Our goal is to introduce novel products that actively stimulate and rejuvenate the human body to combat disease and enhance the ability to heal. We are an industry leader in the advancement of low-dose non-injectable interferon as a therapeutic treatment for numerous indications such as thrombocytopenia, Sjögren's syndrome, hepatitis C virus (HCV) and influenza, a potential multi-billion dollar market opportunity. ABI primarily operates through three divisions: Pharmaceutical, Medical and Consumer. The Pharmaceutical division leverages a proprietary library of over a hundred scientific and clinical data studies on various human and animal applications of low-dose interferon, for patent licensing and commercialization opportunities with global partners. The Medical division is focused on developing an innovative, state-of-the-art technology to treat metabolism related diseases such as Type 1 and Type 2 diabetes in Asia. The Consumer division includes a range of nutraceutical and food supplement products that utilize our unique liposomal delivery systems. ABI currently has offices in the United States and Taiwan.
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FORWARD-LOOKING STATEMENTS. EXCEPT FOR THE HISTORICAL INFORMATION CONTAINED HEREIN, THE MATTERS DISCUSSED IN THIS PRESS RELEASE ARE FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES. THE FOLLOWING IMPORTANT FACTORS COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE IN THE FORWARD-LOOKING STATEMENT, INCLUDING, BUT NOT LIMITED TO, THE ANTICIPATED AVAILABILITY AND POTENTIAL BENEFITS ASSOCIATED WITH THE USE OF THE PROPOSED TREATMENTS, PRODUCT QUALITY, MANUFACTURING OR SUPPLY, OR PATIENT SAFETY ISSUES, UNCERTAINTIES RELATED TO PRODUCT DEVELOPMENT, REGULATORY AND OTHER GOVERNMENT APPROVALS UNDER INTERNATIONAL AND U.S. LAWS, THE EFFICACY OF PROPOSED TREATMENTS AND THE OUTCOME OF CLINICAL TRIALS, DEPENDENCE ON THIRD-PARTY PROPRIETARY TECHNOLOGY, INGREDIENTS, AND MATERIALS, MARKET DEMAND AND ACCEPTANCE OF ORAL INTERFERON OR THE COMPANY’S OTHER PRODUCT CANDIDATES, COMPETITIVE PRODUCTS AND TREATMENTS THAT CURRENTLY EXIST OR THAT ARE IN DEVELOPMENT, AND OTHER RISKS DETAILED FROM TIME TO TIME IN THE COMPANY’S FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. ABI DOES NOT UNDERTAKE TO UPDATE ITS FORWARD-LOOKING STATEMENTS.
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