OCALA, FL / August 27, 2020 / AIM ImmunoTech Inc. (NYSE American:AIM) is pleased to announce that it has identified an effective in vitro model at The Institute for Antiviral Research at Utah State University for testing Ampligen, a dsRNA TLR3 agonist, and the results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels. This result supports AIM’s goal of developing an intranasal prophylactic approach using Ampligen to prevent COVID-19.
"We are pleased with these results, as they establish Ampligen’s bio-activity against SARS-CoV-2 as well as support our decision to test Ampligen in humans as an intranasal prophylaxis and early-onset therapy against COVID-19," said AIM CEO Thomas K. Equels.
The 3D-mucociliary tissue culture of normal, human-derived tracheal/bronchial epithelial cells sufficiently models some of the key innate immune responses needed to demonstrate Ampligen’s prophylactic effect on SARS-CoV-2, the virus that causes COVID-19. The 90% effective concentration (EC90) of Ampligen observed in this tissue culture model is clinically achievable in human subjects to presumptively decrease SARS-CoV-2. Currently, there is a lack of an adequate animal model and therefore the company utilized the USA-WA1/2020 strain of SARS-CoV-2 in a 3-D, in vitro model of normal, human-derived tracheal/bronchial epithelial cells. The results show that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels. This result supports AIM’s goal of developing an intranasal prophylactic approach using Ampligen to prevent COVID-19.
Ampligen is believed to be a powerful positive modulator of human innate immunity and therefore the best measure of efficacy will be obtained in animal and human experimentation utilizing a living, in vivo, innate immune system.
In a brief recap of AIM’s experimental history in SARS-like diseases, Ampligen has demonstrated clear activity in prior SARS-CoV-1 virus animal experiments. With a SARS-CoV-1 virus mouse model, Ampligen demonstrated 100% protective survival benefit compared to 100% mortality in a saline control group. Ampligen also reduced SARS-CoV-1 lung titers to below the level of detection (Day 2009 and Barnard 2006). However, because similar animal models with mice designed to replicate the human response to SARS-CoV-2 are not yet readily available for experimentation, AIM sought an in vitro experimental model. However, as previously disclosed, the typical cell line for viral experimentation, cloned AGM cells, have lost the genetic capacity to allow Ampligen’s biomechanics to be expressed. This general effect was first observed and reported in 2006 in Table 1 of the Barnard, et al. publication in Antiviral Chemistry and Chemotherapy 2006, 17:275. See also, (https://dd7pmep5szm19.cloudfront.net/2265/0001493152-20-011683.htm)
In 2006, recognizing this defect in the in vitro model, Barnard, et al. then used an in vivo mouse model and Ampligen showed high antiviral activity with reduction in lung titers of SARS-CoV-1 to below the level of detection. Then, in a 2009 follow-up animal experiment, Ampligen demonstrated 100% protective survival as compared to 100% mortality in the control group of rodents.
For these reasons, while awaiting the availability of future in vivo animal experimental data and human clinical data, AIM pursued this more relevant in vitro model to demonstrate Ampligen’s positive bioactivity against the virus that causes COVID-19 using a model consisting of normal, human-derived tracheal/bronchial epithelial (TBE) cells which have been cultured to form a multi-layered, highly differentiated model that closely resembles the epithelial tissue of the respiratory tract. These cells still retained both toll-like receptors as well as the ability to produce and react to interferons induced by Ampligen.
This demonstration of Ampligen’s bioactivity against SARS-CoV-2, resulting in a significant in vitro reduction of infectious virus at clinically achievable doses confirms our commitment for the development of Ampligen as both a prophylaxis and early onset intranasal therapy for COVID-19.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM’s flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.
Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. For example, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models and in vitro testing do not necessarily predict results in humans or ultimate FDA approval. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. We recognize that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.
CONTACT:
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AIM ImmunoTech Inc
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Email: IR@aimimmuno.com
SOURCE: AIM ImmunoTech Inc.
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