Amarillo Biosciences to Explore Low-Dose Oral Interferon Therapeutics in China as a Line of Defense Against Coronavirus and Other Viral Indications
Amarillo, TX - (NewMediaWire) - February 13, 2020 - Amarillo Biosciences, Inc. (“ABI” or the “Company”), (AMAR), a diversified healthcare company, today announced that its China licensing partner, Xiamen Weiyang Pharmaceutical Co., Ltd. (“Xiamen Weiyang”), has begun initiating the sharing of proprietary clinical research information with health officials in China to potentially explore the effect of ABI’s low-dose oral interferon in combating the spread of novel coronavirus, now officially known as Covid-19, along with other related viral indications such as influenza. There are currently no approved therapeutics or vaccines for Covid-19.
While dialogue with Chinese health officials are still in its early stages, Xiamen Weiyang will focus on seeking appropriate regulatory channels in which to either fast track formalized clinical research trials for low-dose oral IFN-α, or at the very least expedite the development process with Chinese health authorities to pave the way for proactive studies in preparation of future similar viral outbreaks. Xiamen Weiyang will work closely in conjunction with ABI’s subsidiary branch office in Taiwan, where the Company already has a local presence and maintains a medical facility staffed with specialist physicians and senior research personnel ready to deploy when necessary.
The threat from the novel coronavirus outbreak has recently prompted the China National Health Commission to formally recommend the use of anti-AIDS drugs and inhalable interferon. Several antiviral treatments including ribavirin, interferons and the anti-HIV combination lopinavir/ritonavir or remdesivir are under investigation for use against MERS-CoV infection and have been initiated against the Covid-19. This has brought renewed attention to the importance of delivering interferon in a safe and effective manner to treat Covid-19 and other various viral indications not just in China, but globally.
"Given the tragic viral outbreaks throughout the past decade and resulting death toll, there is no doubt that virus prevention and effective treatment is an urgent and growing public health issue for the foreseeable future," said Stephen T. Chen, Ph.D. and Chief Executive Officer of ABI. “While the recent novel coronavirus situation highlights the need for better preparedness, it also brings to light the imperative need for safe, viable treatment solutions such as low-dose oral interferon as part of a first line of defense to prevent the proliferation of Covid-19 and other viral diseases such as influenza where in the U.S. alone, more than 10,000 people have already died from the flu and unreported flu-related illnesses this season.”
Interferon and its various sub-types are key modulators in our innate immune response to viral infection. Almost every cell in the body can produce interferon when under attack, but interferon seems to be especially important in the cells that form the frontline defense with the outside world, such as the oral and nasal mucosa. Its anti-viral effects include inhibition of viral replication, destruction of virus-infected cells, and activation of other, important immune cells. Interferon-alpha (IFN-α), specifically, has anti-proliferative effects which can be targeted at rapidly spreading viruses or rapidly dividing cancer cells.
ABI has been a leader in the development of low-dose oral IFN-α and is uniquely positioned to develop safe, low-dose interferon therapeutics in China with its licensing partner, Xiamen Weiyang. We have amassed 30 years of expertise in the use of low-dose oral IFN-α for applications ranging from the common cold and warts to cancers, HIV and hepatitis. The therapeutic diversity of IFN-α stems from its ability to induce the transcription of hundreds of genes that stimulate the immune system. Our animal and human clinical trials have shown promise to deliver equal or superior efficacy to the high-dose systemic IFN-α currently available, but with none of the adverse effects. In clinical studies, ABI’s proprietary oral IFN-α formulation lozenges exert both local and systemic effects, but at such low doses that the adverse effects which plague high-dose injectable IFN are not an issue. In fact, low-dose oral IFN-α has even been shown to reverse some of the adverse effects caused by high-dose IFN such as in thrombocytopenia. And because of ABI’s several patents for the treatment of thrombocytopenia using orally administered IFN-α, our company is in prime position to meet this need.
The Covid-19 outbreak bears striking similarities to the previous SARS-CoV epidemic of 2002-2003, at which time ABI considered low-dose oral IFN-α as a viable effective treatment. Antivirals such as interferon have been utilized in the treatment of HIV, hepatitis and influenza. They can help boost a patient’s immune system to kill viruses or prevent them from replicating. Although massive injections or IV applications of interferon have been successfully used to fight human viruses, this approach is expensive and much too toxic. High dosage interferon is known to cause mood disorders, increased infections and stroke, according to the US Food and Drug Administration. By contrast, orally delivered human interferon alpha can be easily and inexpensively used to modulate the immune system in a non-toxic way.
ABI stands firmly committed in sharing its available research data to assist the Chinese medical community in this time of need and endeavor to offer whatever tangible value low-dose oral interferon can contribute as a line of defense to contain the spread of Covid-19. Unlike vaccines, that have to be frequently reformulated to fight whichever viral strains are circulating, low-dose oral IFN-α has the potential to be a 'one-size-fits all' drug by priming the immune system to fight a range of viruses.
We all hope that the Covid-19 outbreak will be contained in the shortest amount of time possible but only support of more research into emerging viral diseases will mean that outbreaks like these are no longer threats to humanity. ABI plans to continue to investigate potential opportunities to cooperate with other like-minded biopharmaceutical companies to further develop therapeutic studies with low-dose oral IFN-α for applicable indications such as influenza, and we extend an open invitation to any interested organizations seeking to collaborate.
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 oral 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 oral 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, in addition to licensed distribution of surgical wound care products. 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.
About Xiamen Weiyang Pharmaceutical Co., Ltd.
Xiamen Weiyang Pharmaceutical Co., Ltd is a private company led by a group of scientists and business professionals with extensive experience in the US and Chinese pharmaceutical industry. We are absorbed in R&D, synthesis process development, manufacturing, and deliver superior sourcing solutions in the pharmaceutical sector. We aim to achieve a strong presence in the synthesis process and manufacturing in the field of active pharmaceutical Ingredients (APIs) and formulation, especially in anti-viral areas, and attaining strong recognition both domestically and internationally. We pay close attention to the latest medical technology and worldwide chemical synthesis processes. As a result of our unremitting efforts, we have successfully developed newer synthesis process for API and its intermediates for new drugs of anti-HBV/HCV/HIV. Our synthesis laboratory and ton-scale raw material factory are also built for providing the best service to customers.
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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 TERMS, CONDITIONS, AND CONSUMMATION OF A DEFINITIVE AGREEMENT BETWEEN ABI AND XIAMEN WEIYANG, 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 CHINESE 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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