Ainos’ VELDONA Granted Orphan Drug Designation by U.S. FDA for Potential Treatment of Oral Warts in HIV-Seropositive Patients
VELDONA® positioned as a potential treatment option for over 24,000 HIV-seropositive Americans
SAN DIEGO, CA / ACCESSWIRE / September 18, 2023 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, announced today that the United States Food and Drug Administration (the "U.S. FDA") granted Orphan Drug Designation ("ODD") for the Company's VELDONA® low-dose oral interferon formulation as a potential treatment for oral warts in HIV-seropositive patients. Ainos plans to pursue a pre-IND meeting with the U.S. FDA in advance of planned Phase III clinical studies for the drug candidate.
Mr. Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, "We are deeply excited that VELDONA® may be able to improve the quality of life of many people living with HIV. Of the estimated 1.2 million HIV-seropositive people in the United States, about 24,000 of them suffer from HIV-related oral warts, representing approximately 2% of the HIV-seropositive population. It is estimated that oral warts affected around 1.2 million HIV patients worldwide in 2022. Oral warts can significantly reduce a person's quality of life, causing discomfort during routine activities such as eating and talking, and affecting a person's appearance. We are optimistic that VELDONA® will serve as a new option for HIV-seropositive individuals seeking relief from oral warts."
Human immunodeficiency virus, more commonly known as HIV, is a disease which destroys the body's CD4 cells, which are crucial to immune function. It can increase a patient's susceptibility to opportunistic infections such as human papillomavirus ("HPV"), tuberculosis, and fungal and bacterial infections. HPV infection has been identified as the most significant risk factor in the development of oral lesions among the HIV-seropositive population. Viral lesions on the mouths of HIV patients are common and may be indicative of disease progression.
Current treatment options for HIV-related oral warts are limited. Pharmacological treatment of intraoral and labial warts is not well established, with no clinical trials specifically targeting this indication. Only a handful of case reports exist involving the use of drugs such as cidofovir, bleomycin, cimetidine, podophyllum, or intralesional interferon-alpha injections. Oral warts can be surgically removed if they interfere with eating and speaking, or if they are cosmetically displeasing, though surgical removal comes with a risk of local recurrence. The location of the warts and the amount of tissue remaining after removal must also be considered when debating surgical resection.
Ainos has conducted three trial studies for the treatment of oral warts in HIV-seropositive patients. The first was an open-label pilot study involving 15 HIV-seropositive males with multiple oral warts. The second was a single-blind, dose-ranging study involving 21 HIV-seropositive subjects with multiple oral warts who received combination anti-retroviral therapy with or without PI. The third was a double-blind, placebo-controlled trial involving a total of 80 HIV-seropositive participants on highly active antiretroviral therapy ("HAART"), randomized to IFN-alpha (n=60) or placebo (n=20) for up to 24 weeks. The Company's studies demonstrated positive therapeutic efficacy and a lack of significant toxicity. Ainos plans to pursue a pre-IND meeting with the U.S. FDA and plans to advance its VELDONA® formulation to Phase III clinical trials.
The U.S. FDA's Orphan Drug Designation is a special status granted to foster the development and evaluation of new medicines designed to treat, diagnose, or prevent diseases or disorders affecting fewer than 200,000 people in the U.S. ODD status provides benefits including market exclusivity upon regulatory approval, exemption from FDA application fees, and tax credits for qualified clinical trials.
About Ainos, Inc.
Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing ("POCT"), low-dose VELDONA interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA clinical-stage human therapeutics, VELDONA Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common sexually transmitted infections ("STIs"). To learn more, visit https://www.ainos.com.
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Forward Looking Statements
This press release contains "forward-looking statements" about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. 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 planned drug treatments announced in this press release; the Company's dependence on projected revenues from the sale of COVID-19 test kits and its VELDONA® Pet line of supplements; 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 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, 2022 and other reports filed 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 reports filed 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. 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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SOURCE: Ainos, Inc.
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