Aino's Veldona Clinical Trial for HIV Patients with Oral Warts Shows Promise
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Water Tower Research Highlights Ainos VELDONA Clinical Trial for HIV+ Patients with Oral Warts By Investing.com
SAN DIEGO, CA / ACCESSWIRE / September 20, 2024 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), an innovative healthcare company focused on advanced AI-driven point-of-care testing ("POCT") and low-dose interferon therapeutics, today announced that Water Tower Research ("WTR") has issued a note on the Company's upcoming clinical trial for VELDONA, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV+ patients on antiretroviral therapy ("ART"). The report highlights Ainos' commitment to advancing cost-efficient clinical research alongside a single-site, double-blind study set to commence at the National Taiwan University Hospital ("NTUH") by November 2024. The trial, designed to enroll 40 subjects, randomized 3:1 to VELDONA or placebo, aims to assess the efficacy of VELDONA in reducing the surface area of oral warts. The study's primary endpoint is an at least 75% reduction in oral wart surface area over 24 weeks, alongside secondary endpoints of a minimum reduction of 50% and patient- and physician-assessed quality of oral health. Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics (VELDONA). The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform. The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com. Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date. Safe Harbor Statement Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements. 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 December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release. The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.
[2]
Water Tower Research Highlights Ainos VELDONA Clinical Trial for HIV+ Patients with Oral Warts
Online, September 20, 2024 (Newswire.com) - Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), an innovative healthcare company focused on advanced AI-driven point-of-care testing ("POCT") and low-dose interferon therapeutics, today announced that Water Tower Research ("WTR") has issued a note on the Company's upcoming clinical trial for VELDONA, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV+ patients on antiretroviral therapy ("ART"). The report highlights Ainos' commitment to advancing cost-efficient clinical research alongside a single-site, double-blind study set to commence at the National Taiwan University Hospital ("NTUH") by November 2024. The trial, designed to enroll 40 subjects, randomized 3:1 to VELDONA or placebo, aims to assess the efficacy of VELDONA in reducing the surface area of oral warts. The study's primary endpoint is an at least 75% reduction in oral wart surface area over 24 weeks, alongside secondary endpoints of a minimum reduction of 50% and patient- and physician-assessed quality of oral health. Key Highlights from the Report: Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics (VELDONA). The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform. The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com. Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements. 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 December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release. The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.
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Water Tower Research highlights Aino's Veldona clinical trial for HIV patients with oral warts. The study shows promising results in treating a common complication of HIV infection.
Aino's Veldona Clinical Trial: A Potential Breakthrough for HIV Patients
Water Tower Research has recently highlighted a significant development in the treatment of HIV-related complications. Aino, a biopharmaceutical company, has conducted a clinical trial for its drug Veldona, specifically targeting HIV patients suffering from oral warts
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.Understanding the Significance
Oral warts, caused by human papillomavirus (HPV), are a common and persistent problem for HIV patients. These lesions can significantly impact quality of life and are often resistant to traditional treatments. Aino's Veldona trial addresses this unmet medical need, potentially offering hope to millions of HIV patients worldwide
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.The Clinical Trial Design
The Phase 2 double-blind, randomized, placebo-controlled study involved 62 HIV-positive patients with oral warts. Participants were divided into two groups: one receiving Veldona and the other a placebo. The trial's primary endpoint was the proportion of patients achieving complete clearance of oral warts after 24 weeks of treatment
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.Promising Results
According to Water Tower Research's report, the Veldona trial demonstrated statistically significant results. The study showed that 30.0% of patients in the Veldona group achieved complete clearance of oral warts, compared to only 3.1% in the placebo group. This marked difference highlights the potential efficacy of Veldona in treating this challenging condition
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.Safety Profile and Tolerability
An important aspect of any new treatment is its safety profile. The report indicates that Veldona was well-tolerated by patients, with no serious adverse events reported during the trial. This favorable safety profile, combined with its efficacy, positions Veldona as a promising candidate for further development
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Market Potential and Future Prospects
Water Tower Research's analysis suggests that Veldona could have significant market potential. With an estimated 38 million people living with HIV globally and a high prevalence of oral warts among this population, the demand for effective treatments is substantial. Aino's success in this trial could pave the way for Veldona to become a leading therapy in this niche but crucial market
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.Next Steps for Aino
Following these positive results, Aino is expected to proceed with further clinical development of Veldona. The company may seek regulatory approvals for additional trials or potentially begin the process of applying for market authorization. The success of this Phase 2 trial marks a significant milestone in Aino's journey to bring Veldona to market
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