Low-Dose Oral IFN

Interferon-α (IFN-α) is a key modulator 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. IFN-α also has anti-proliferative effects which can be targeted at rapidly spreading viruses or rapidly dividing cancer cells.

High-dose systemically administered IFN-α has been used alone or in combination to treat a variety of disease states, including hepatitis C, polycythemia vera, and adult T-cell leukemia/lymphoma (ATLL). While IFN-α has powerful anti-viral and anti-proliferative actions, its therapeutic success has been limited by a host of adverse effects resulting from injection of high doses, including some life-threatening, such as neutropenia and thrombocytopenia.

Amarillo Biosciences (ABI) has been a leader in the development of low-dose oral IFN-α that in animal and human clinical trials has shown promise to deliver equal or superior efficacy to the high-dose systemic IFN-α currently available, but with none of the adverse effects. The lower dose of IFN-α and its absorbance across the mucous membrane of the oral cavity, more closely mimics our innate immune response.

In clinical studies, ABI’s proprietary oral IFN-α formulation lozenges (“lozenge” or “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 patent for the treatment of thrombocytopenia using orally administered IFN-α, our company is in prime position to meet this need.

ABI has 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 and HIV. The therapeutic diversity of IFN-α stems from its ability to induce the transcription of hundreds of genes that stimulate the immune system. These genes affect numerous parts of the innate and adaptive immune system such as antigen processing and presentation, leukocyte migration, lymphocyte activation, immune effector and modulation functions, apoptosis, hematopoiesis, enzymatic destruction of viral RNA, and more.

Although low-dose oral IFN-α has the potential to be used therapeutically in a number of indications, ABI has immediate plans to build on our past successful treatment of virus-induced ulcers, sores and growths of the mouth and throat with oral IFN-α, and to focus new efforts in the treatment of cancers of the throat. ABI also has future plans to investigate the usefulness of oral IFN-α as an adjuvant therapy in cancer, specifically its role in reversing the immunosuppressive tumor microenvironment and in preventing some of the dangerous side-effects of chemotherapy such as thrombocytopenia.

In addition to holding six patents and one registered trademark for oral IFN-α, and a long history of studying the effects of IFN-α on a plethora of disease states in animals and humans, ABI has developed a process for manufacturing lozenges which are stable at room temperature, making them easy and inexpensive to transport, store, and administer.

Clinically Proven Advantages of Amarillo Bioscience-manufactured lozenges:

  • Safe treatment, no known adverse side-effects
  • Convenient oral dosage form
  • Lower cost
  • Long shelf-life at room temperature

ABI is continually exploring the modernization of interferon technology by researching new sources and types of interferon. The company is looking into possibilities of new interferon production, preparation, and purification methods as well as new, more effective and efficient delivery methods.

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