Notes reports of potential surge in CFS-like cases worldwide as a result of COVID-19, the disease caused by the SARS-CoV-2 coronavirus
OCALA, FL / June 11, 2020 / AIM ImmunoTech (NYSE American:AIM), today announced that it has filed a provisional patent application for, among other discoveries, the use of its experimental drug Ampligen® as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue, which shows similarities to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Ampligen®, approved in Argentina, is late-stage in the experimental development pipeline in the U.S.
While there is ongoing and planned research by the U.S. Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH) and other groups to study chronic fatigue in post-COVID-19 patients, the Company believes Ampligen may play an important role in addressing this multi-faceted disease.
Dr. Charles Lapp of Hunter-Hopkins Center, one of the world's leading experts in ME/CFS, who is one of the investigators treating CFS patients with Ampligen under an FDA-authorized open-label expanded access treatment protocol, noted, "It is anticipated that COVID-19 will trigger a large number of CFS cases, providing an opportunity for the medical community to learn more about the onset and pathogenesis of CFS. The investigational immune-modulating antiviral drug Ampligen might have a role to play in this scenario." Although the specific etiology and exact causes of ME/CFS are not known at this time, research suggests there may be multiple variants of the disease with an array of symptoms that often follow severe viral infection. The Institute of Medicine estimates that between 800,000 and 2.5 million U.S. residents live with ME/CFS, and that an estimated three-quarters of these cases were triggered by viral or bacterial infections. Such agents may include the coronavirus, the Epstein-Barr virus, the Ross River virus, and the bacterium, Coxiella burnetii which causes Q fever.
As recently reported in the Washington Post, researchers are concerned about a potential surge in a CFS-like illness in patients recovering from COVID-19, as similar viral outbreaks in the past have led to increased numbers of post viral fatigue patients. Specifically, the Washington Post article noted that after the first SARS epidemic, one study published in JAMA Internal Medicine found that 27 percent of survivors met the criteria for CFS several years later. As further noted by Simmaron Research, "…the high numbers of younger people being hospitalized for COVID-19 suggests considerable numbers of people in the prime of their lives may have an ME/CFS-like illness in their future."
Thomas K. Equels, CEO of AIM ImmunoTech, commented, "Worldwide, we may still be in early stages of the pandemic, and yet there are already over 7 million confirmed COVID-19 cases worldwide and approximately 2 million confirmed cases in the U.S. alone. As a result, we believe there exists a significant risk of SARS-CoV-2 induced chronic fatigue among the millions of survivors of COVID-19, as we have witnessed in the prior SARS-CoV-1 epidemic. Given the large amount of clinical data already supporting Ampligen in ME/CFS we look forward to the chance to investigate how Ampligen may be of value should there be a surge of COVID-19 induced CFS-like cases worldwide. We also commend the bipartisan efforts of Senator Markey and other Senators calling for medical research into CFS in the upcoming COVID-19 relief package."
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.
The Company is also advancing Ampligen® as a potential treatment for COVID-19, the disease caused by the SARS-CoV-2 coronavirus, and believes Ampligen® has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. The U.S. Food and Drug Administration has authorized the first human trial assessing the safety and effectiveness of Ampligen® in combination with interferon alfa-2b, in cancer patients with COVID-19.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act 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. These statements involve a number of risks and uncertainties. For example, testing will be required to determine whether or not Ampligen will assist in the treatment of COVID-19 induced CFS-like cases. With regard to the Company's activities with Ampligen® generally, no assurance can be given as to whether current or planned 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. With regard to the Company's activities related to COVID-19, 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. In this regard, the FDA approval of the IND is the first step and no assurance can be given as to whether the Roswell trial and/or subsequent trails will prove successful. Some of the world's largest pharmaceutical companies 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, even if Ampligen® proves effective, another treatment that eventually proves effective will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies we are relying on. 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. Commercialization in Argentina still requires, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch. Approval of rintatolimod for severe CFS in Argentina does not in any way suggest that the Ampligen® NDA in the United States or any comparable application filed in the European Union or elsewhere will obtain commercial approval. Any forward-looking statements set forth herein speak only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.
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AIM ImmunoTech Inc
SOURCE: AIM ImmunoTech Inc