For over three decades, Ainos researched the natural disease fighting capabilities of the human body. Backed by over 100 research and clinical studies, we developed Veldona, a low-dose oral interferon-alpha
(IFN-α) formulation to boost the human body’s frontline defenses against disease and infection.
Applications for this innovative therapeutic range from influenza to cancers. Ongoing clinical trials are focused on commercializing two disease indications, thrombocytopenia and Sjögren’s syndrome.
IFN-α is a key component of our body’s innate immune response to viral infection. Most cells in the body will produce interferon when attacked. The most active cells operate on the frontline of defense within the oral and nasal cavities. Named for their ability to “interfere” with viral replication, interferons can destroy viral-infected cells, activate other immune cells, or slow rapidly spreading viruses.
High-doses of IFN-α are utilized to treat a variety of diseases including hepatitis C, polycythemia vera, and adult T-cell leukemia/lymphoma (ATLL). Whether administered alone or in combination therapy, the therapeutic success of high-dose IFN-α is limited by a string of severe adverse effects including dangerously low blood cell counts such as neutropenia or thrombocytopenia.
Ainos team has developed a proprietary low-dose IFN-α with equal or superior efficacy to high-dose systemic IFN-α. In clinical safety studies, our oral IFN-α lozenge shows strong efficacy without the adverse effects that plague high-dose injectable IFN-α. Early data also shows low-dose IFN-α can reverse some of the adverse effects caused by high-dose IFN-α.
Our next generation of Veldona therapeutics will come from partnering with top research and medical experts to develop new IFN-α formulations and delivery modalities.
Low-dose oral IFN-α can contribute to reversing the immunosuppressive tumor microenvironment and prevent some of the dangerous side-effects of chemotherapy such as thrombocytopenia. Ainos is now leveraging previous clinical trial data and experience to prepare a well-designed protocol to demonstrate Veldona’s efficacy in treating thrombocytopenia, and expects to progress to late-stage clinical trials.
Sjögren’s syndrome is an immune system disorder characterized by dry eyes and dry mouth. With this condition, the body's immune system attacks its own healthy cells that produce saliva and tears. Sjögren's often occurs with other autoimmune disorders, such as rheumatoid arthritis and lupus. Ainos previously reached two phase 3 trials for this disease indication. We plan to design a future phase study based on previous FDA guidance received during its last phase 3 trial.