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Water Tower Research Highlights Ainos VELDONA Clinical Trial for HIV+ Patients with Oral Warts
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, …
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.
Key Highlights from the Report:
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VELDONA Clinical Trial: The clinical study is subject to Investigational Review Board approval by NTUH and Taiwan Food and Drug Administration, with expectations to complete by July 2026 at a one-year patient enrollment. This trial is in alignment with Ainos' capital efficient strategy as clinical studies in Taiwan cost less in comparison to that in the U.S.
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Positive Phase 2 Data: A previous Phase 2 trial conducted in the U.S. demonstrated promising results, with VELDONA outperforming the placebo in reducing the area of oral warts in HIV+ patients.
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Orphan Drug Designation: VELDONA has received Orphan Drug Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of oral warts in HIV+ patients, a group with limited therapeutic options.
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Unmet Medical Need: There are no approved therapeutics for oral warts, which affect approximately 49,000 HIV+ patients in the U.S. alone. Current treatments, including surgical excision, carry risks of recurrence and progression to more serious conditions, underscoring the critical need for new treatment options like VELDONA.
About Ainos, Inc.
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.
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