Maker13
4 월 전
Ainos Announced Plan to Initiate Taiwan Clinical Study for VELDONA as Potential Treatment of Oral Warts in HIV-Seropositive Patients, an Orphan Drug Designated by the FDA
Company Update
Ainos Plans To Conduct the Study at National Taiwan University Hospital, a Premier Taiwanese Medical Center for HIV Management
The U.S. FDA Have Granted Orphan Drug Designation (ODD) for the Company's VELDONA® Low-Dose Oral Interferon Formulation as a Potential Treatment for Oral Warts in HIV-Positive Patients
SAN DIEGO, CA / ACCESSWIRE / September 17, 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, is pleased to announce that its plans to initiate a clinical study for very low-dose interferon alpha (VELDONA) on treating Human immunodeficiency virus (HIV)-related oral warts at the National Taiwan University Hospital. The study aims to evaluate the efficacy of VELDONA®, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV-positive patients undergoing combination antiretroviral therapy. VELDONA® has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for this indication, offering new hope to HIV-positive individuals suffering from oral warts.
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Overview of the Clinical Study
This clinical study will be conducted by the Infectious Disease Department at National Taiwan University Hospital, one of Taiwan's 25 designated medical centers for HIV management. The hospital oversees nearly 4,000 HIV-positive patients, approximately 11.2% of Taiwan's total HIV cases. The study will enroll 40 participants who will be randomized in a 1:3 ratio to receive either a placebo or VELDONA® in a double-blind trial. Participants will take VELDONA® or a placebo sublingually every day for 24 weeks.
The primary objective of the study is to evaluate the reduction in oral warts' surface area. A successful response is defined as a reduction of 75% or more in the surface area of oral warts compared to baseline, while a non-responsive result indicates less than 75% reduction.
The secondary objectives include evaluating oral wart surface area reduction by 50% or more, as well as participant self-assessments through questionnaires comparing oral health to baseline conditions. The study's Principal Investigator (PI) will also objectively assess the participants' oral conditions.
This clinical study will be conducted in accordance with Good Clinical Practice (GCP) guidelines by Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization (CRO). The study is expected to begin in November 2024, with the first patient visit (FPFV) anticipated in November. Patient enrollment is projected to take one year, with the last patient visit (LPLV) expected in May 2026, and study completion anticipated in July 2026. Protocol of the study is currently being reviewed for Investigational Review Board ("IRB") approval by National Taiwan University Hospital and Taiwan Food and Drug Administration (TFDA).
Data from Prior Studies
Ainos has conducted one pilot study and two phase 2 trials in the U.S. involving 77 HIV-positive patients with multiple oral warts. In these trials, patients were randomized to receive either VELDONA® or a placebo, taking the medication three times daily for 24 weeks. After treatment, patients receiving VELDONA® showed significant reductions in oral wart surface area, with decreases of over 75%, and in some cases up to 99%.
Overview of HIV
Human Immunodeficiency Virus (HIV) is the virus responsible for causing AIDS, with two main types: HIV-1 and HIV-2. HIV-1 is the dominant strain worldwide and is the primary cause of AIDS in most countries. HIV-2, found predominantly in West Africa, is less virulent and less likely to progress to AIDS.
According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2023, there were approximately 39.9 million people living with HIV worldwide, with 1.3 million new infections and about 630,000 AIDS-related deaths.
In Taiwan, there were around 35,500 individuals living with HIV and 940 reported new cases in 2023. There were 666 new reported cases in August 2024.
Challenges in Treating HIV-Related Oral Warts
Currently, treatment options for HIV-related oral warts are limited, and no established pharmacological therapies exist for this condition. Only a few case reports mention the use of drugs such as cidofovir, bleomycin, cimetidine, podophyllum, or intralesional interferon-alpha injections. Surgical removal is possible but comes with the risk of recurrence.
Ainos believes that VELDONA® has the potential to be a safe and effective treatment for oral warts in HIV-positive individuals, offering a meaningful improvement in their quality of life.
"We are excited by the data we've gathered so far and are optimistic about the potential of VELDONA® to benefit many HIV-positive patients. Oral warts can significantly affect daily activities such as eating and speaking, as well as a person's appearance. We are hopeful that VELDONA® will become an important option for those seeking relief from these symptoms," said Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos
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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.
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.
Contact Information
Feifei Shen
ir@ainos.com
SOURCE: Ainos, Inc.
https://www.accesswire.com/918831/ainos-announced-plan-to-initiate-taiwan-clinical-study-for-veldona-as-potential-treatment-of-oral-warts-in-hiv-seropositive-patients-an-orphan-drug-designated-by-the-fda
Maker13
5 월 전
Ainos Secures Taiwan Invention Patent and Advances Global Patent Protection for VELDONA, a Breakthrough in Coronavirus Treatment and Prevention
This patent marks a major leap in Ainos' antiviral research, contributing to global efforts against coronavirus infections
SAN DIEGO, CA / ACCESSWIRE / September 3, 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, is pleased to announce that its groundbreaking VELDONA® formulation has been granted an invention patent in Taiwan and has filed for global patent protection under the Patent Cooperation Treaty (PCT). This patent represents a significant milestone in the treatment and prevention of coronavirus infections.
The patented technology, titled "METHOD AND COMPOSITION OF TREATMENT OR PREVENTION OF CORONAVIRUS INFECTION" with patent number TW202402785A, showcases a novel therapeutic approach using VELDONA® as the primary ingredient, which we believe significantly enhances immune system function and effectively reduces the risk of coronavirus infections.
After nearly four decades of relentless research, Ainos' latest breakthrough demonstrates that VELDONA® can substantially boost the immune system, providing robust protection against coronavirus infections. Unlike traditional injectable or oral therapies, VELDONA® utilizes an advanced oral rapid-dissolving tablet technology, allowing for quick absorption through the sublingual or buccal mucosa, thereby improving the drug's bioavailability and significantly enhancing patient compliance.
Further studies have shown that VELDONA® not only activates the immune system to combat various coronavirus variants but also exhibits exceptional potential in preventing new coronavirus infections, offering a dual defense mechanism that provides comprehensive protection for patients.
Moreover, we believe the application of VELDONA® extends beyond coronaviruses. Interferon has been successfully applied to treat various other viral diseases, including Hepatitis B, Hepatitis C, HIV, Feline Immunodeficiency Virus (FIV), Feline Leukemia Virus (FeLV), and Canine Parvovirus (CPV). Given the powerful immune-inducing properties of interferon, VELDONA® holds the potential to become a comprehensive antiviral therapy against multiple viral infections.
With its high efficacy, safety, and low side effects, VELDONA® is poised to become one of the most competitive antiviral drug ingredients on the market, demonstrating its tremendous potential as an all-encompassing antiviral medication.
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Dr. Albert Yu, Technical Director of Pharmaceuticals and one of the primary inventors of the patent, stated, "Securing this patent is a significant milestone for the Company, and it also opens new possibilities in the global fight against coronavirus infections. We look forward to the widespread clinical application of VELDONA® worldwide and will continue to drive the development and application of more innovative drugs."
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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.
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.
Investor Relations Contact
Feifei Shen
Email: IR@ainos.com
SOURCE: Ainos, Inc.
https://www.accesswire.com/911286/ainos-secures-taiwan-invention-patent-and-advances-global-patent-protection-for-veldonar-a-breakthrough-in-coronavirus-treatment-and-prevention
Maker13
5 월 전
Ainos CEO Highlights AI Nose Achievements and Upcoming 2H 2024 Milestones in Shareholder Letter
Embarking on a journey to ultimately becoming AI's nose capable of digitizing smell
AI Nose journey begins in healthcare and is now expanding into smart factories
SAN DIEGO, CA / ACCESSWIRE / August 26, 2024 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on novel AI-powered point-of-care testing ("POCT") and VELDONA low-dose interferon therapeutics, is pleased to provide an update letter to shareholders from its Chairman of the Board, President, and Chief Executive Officer, Mr. Chun-Hsien (Eddy) Tsai.
Dear Shareholders,
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Since rebranding to Ainos, Inc in 2021, our team has worked tirelessly to unlock the full potential of our AI Nose technology. We are on a mission to leverage digital nose sensors and our proprietary volatile organic compounds ("VOC") sensing AI algorithm, to digitize smell and ultimately become AI's nose. Over the past 12 months, I'm proud to say that we have made many significant achievements, and I'd like to recap these milestones as well as our strategies.
Our Endgame: To Become AI's Nose, Starting with Healthcare
We embark our smell digitalization journey from the healthcare market. Looking ahead into the near future, we believe the underlying mega-trend is that as population ages, increasing demand for healthcare will collide with a labor shortage, potentially compromising the quality of health tests. We believe telehealth-friendly point-of-care tests ("POCTs") will be crucial in reducing the burden on healthcare workers.
We anticipate that VOC could be powerful biomarkers for detecting diseases and enabling easy, efficient health monitoring. Powered by AI Nose, we are making POCTs more consumer-friendly, telehealth-compatible, AI-driven, and poised to benefit more people. AI Nose will become increasingly accurate as we train the platform with more data.
Empowering Women's Health and Improving Tests for Sexually Transmitted Infections ("STIs"): Next-Gen Ainos Flora Clinical Study Kickoff in Q4 2024
Our lead product candidate, Ainos Flora, targets women's health and certain common STIs. I believe this market is underserved: about more than 1 million new STIs occur globally every day, and vaginal infections such as bacterial vaginosis (BV) increase risks of STIs. Young people (15-24 year olds) are estimated to account for nearly half of new STI infections in America. POCT is estimated to account for only 31% of the total STI tests. We aim to address these key hurdles to regular screening: convenience, privacy and affordability.
Ainos is developing the next-gen Ainos Flora, optimized for at-home testing. We are fast-tracking development by utilizing NVIDIA CUDA's accelerated computing, targeting Q3 2024 for design completion and Q4 2024 for clinical trial kickoff. We now explore to position the first-gen Ainos Flora for the hospital and clinic market. Our product strategy places Ainos Flora across key use scenarios.
Elderly Care: On Track to Pilot Production in Q4 2024
In August 2023, we kicked off a VOC sensing co-development with Nisshinbo Micro Devices Inc. ("NISD") and Taiwan Inabata Sangyo Co. ("Inabata"). Our shared goal is to broaden addressable market of AI Nose VOC sensing to include telehealth, automotive, industrial, and environmental safety applications.
Our first project focuses on elderly care. The crucial megatrend is that as the global population ages, the increasing demand for elderly care will clash with a labor shortage, leading to compromised care quality. To address this, Ainos and our partners aim to automate certain health monitoring tasks with an AI-driven, telehealth-friendly solution powered by AI Nose VOC sensing.
We plan to first commercialize this product in Japan by collaborating with our co-developers. The population in Japan is aging more rapidly than any other country, with about 36 million Japanese citizens aged 65 and over at almost a third of its population. We are on track to pilot production in 2H 2024.
First Move Beyond Healthcare: AI Nose in Smart Factories; Pilot Production Ready in Q4 2024
Our second co-development program marks our first step in extending AI Nose beyond healthcare. We recognize that smart manufacturing or smart factory requires 1) more AI-driven sensors to capture and analyze data; 2) increased robotic automation to tackle a shrinking workforce. While AI-driven visual data is already well established, AI-driven VOC sensing is still in its early stages. This is evidenced by the lack of digital noses in today's existing humanoid robots. AI Nose can equip robots with a digital sense of smell, enhancing their ability to collaborate with human workers. This improves robot performance and ensures a safer work environment.
We also see vast potential for AI Nose in the semiconductor manufacturing factories, as it has the potential for detecting leaks of photoresist materials, hazardous chemicals and overheating cables.
For now, we are thrilled to announce that AI Nose is 79% accurate in identifying 761 samples across 22 VOCs in Japanese semiconductor manufacturing factories. This validates AI Nose's capabilities in the smart factory market. We target to be pilot production ready in Q4 2024.
New Licensing Strengths AI Nose and POCT IPs
As we advance the previously mentioned programs, we are also strengthening our IP portfolio. We have recently secured exclusive licenses for 10 multi-region invention patents and patent applications surrounding gas sensors and medical device technologies from our product co-developer and sole manufacturer of our POCTs. We completed the transaction with an all-stock structure valued at approximately $5.4 million, or $0.99 per share, which is at a premium to the market price. This structure algins our partner' interests with those of our shareholders and enables us to preserve cash for executing our programs.
Looking Ahead: Confidence in Our Future
As we reflect on our achievements and strategic moves, we remain profoundly optimistic about what the future holds. The milestones we've reached and the strategic programs we are advancing reinforce our confidence in the transformative potential of AI Nose technology.
We are poised to leverage our VOC technological advancements or strategic partnerships to drive significant impact across multiple aspects, from enhancing POCTs for better women's health to revolutionizing elderly care as well as expansion into smart manufacturing. We believe that the progress we have made positions us well for continued growth and success.
As we move forward, we remain focused on executing our plans with precision and agility, continuously pushing the boundaries of innovation. We are excited about the opportunities ahead and we have confidence in our strategic initiatives for empowering our mission of digitizing smell across diverse scenarios.
Thank you for your continued support in our journey.
Key AI Nose Milestones
On August 19, 2024, we announced that AI Nose is has a 79% accuracy rate in identifying 761 samples across 22 VOCs in Japanese semiconductor manufacturing factories. This demonstrates AI Nose's potential to revolutionize the smart manufacturing factory automation and manufacturing safety. We are also planning to integrate AI Nose into robotics systems in smart factories.
On August 9, 2024, we announced that we obtained exclusive licenses for 10 invention patents and patent applications to bolster our AI Nose and POCT technologies. The licensed patents and applications surround gas sensors and medical devices technologies and cover the U.S., Germany, China, Japan and Taiwan. We completed the licensing with an all-stock transaction valued at approximately $5.4 million, or $0.99 per share.
On June 14, 2024, we announced that we will advance the next-gen Ainos Flora with the implementation of NVIDIA CUDA, leveraging critical insights from first-gen Ainos Flora's clinical trials over 75 subjects at four Taiwanese medical centers.
On December 26, 2023, Ainos, NISD and Inabata initiated phase 2 of VOC co-development powered by AI Nose, propelling AI Nose towards broader industry adoption and advancing the mission of digitalizing smell.
On August 9, 2023, we announced that Ainos partnered with NISD and Inabata to co-develop VOC sensing platform powered by AI Nose, kicking off our goal for broader AI Nose industry adoption, and progressing further in our mission for digitizing smell.
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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.
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.
Investor Relations Contact
Feifei Shen
Email: IR@ainos.com
SOURCE: Ainos, Inc.
https://www.accesswire.com/905777/ainos-ceo-highlights-ai-nose-achievements-and-upcoming-2h-2024-milestones-in-shareholder-letter
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