The study is aimed at evaluating the clinical efficacy of low-dose oral interferons in treating feline chronic gingivostomatitis ('FCGS'), a serious and chronic painful oral disease characterized by inflammation or abnormal proliferation in the oral cavity.
This marks another meaningful step in the Company' s strategy for expanding its product line into the global pet care market, which follows the Memorandum of Understanding Ainos signed last year with
Current research suggests that FCGS results from multiple factors, including dental diseases, viral and bacterial pathogens, and environmental conditions, with a reported prevalence ranging between 0.7% and 12%. Despite the frequency of the disease, there are no safe long-term pharmaceutical treatments available to date.
Ainos' VELDONA, a low-dose oral interferon alpha ('IFN') formulation, was initially approved by the
Previous studies have confirmed that interferon administered through the oral mucosa can modulate partial immune system in experimental animals. Furthermore, interferon administered is shown by imaging to be prominently distributed in the lymph nodes of the head and neck, and in some cases, even reaching the lymphatic system surrounding the mesentery. Since the FCGS belongs to diseases of immune system dysregulation, partial oral mucosal administration not only modulates the disordered immune system but also avoids the associated systemic side effects of interferon use, such as immunogenicity and bone marrow suppression.
Ainos's study will involve a randomized, controlled trial with 30 cats divided into two groups: one receiving low doses (6000 IU/time) of the treatment and the other for high doses (12000 IU/time). The main objective is to demonstrate significant health assessment improvements made by both pet owners and veterinarians before and after the treatment. The trials will also evaluate the potential in reducing dosage and frequency of steroids or other immunosuppressive drugs.
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This press release contains 'forward-looking statements' about Ainos within the meaning of the safe harbor provisions of the
Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products ; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market and the Company's success in managing growth. A more complete description of these risk factors and others is included in the 'Risk Factors' section of Ainos' Annual Report on Form 10-K for the year ended
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Contact:
Email: ir@ainos.com
Email: IR@ainos.com
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