Date: 03 Mar 2020
OCALA, FL / ACCESSWIRE / February 27, 2020 / AIM ImmunoTech (NYSE American: AIM, or the Company), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the Company has joined with ChinaGoAbroad (CGA) to facilitate the entry of AIM's experimental drug Ampligen into the People's Republic of China (PRC) for use as a prophylactic/early-onset therapeutic against COVID-19, the new SARS-like coronavirus infection that has reached epidemic proportions.
CGA is a member-based online information platform and offline advisory firm serving to facilitate two-way international transactions relating to the PRC in close collaboration with the China Overseas Development Association (CODA), which had up until recently reported to the PRC National Development and Reform Commission (NDRC), which in turn reports to the State Council (China's cabinet). CGA is already involved in China's ongoing efforts to halt the growing COVID-19 epidemic and, among other engagements, has been assigned to assist with the international purchase by Sinopharm Group - a Chinese state pharmaceutical company - of technology, masks, gowns and gloves.
"AIM is working aggressively to advance the introduction of Ampligen into China, in order to provide the Chinese people with a potential first line of defense against the deadly COVID-19 virus. AIM and CGA have taken this first step to facilitate discussions with the Chinese government for Ampligen's entry into China as a targeted prophylactic/early-onset therapy," said AIM CEO Thomas K. Equels. "Ampligen achieved a 100% survival rate, as compared to 100% mortality in the untreated control animals, in SARS animal experiments after the outbreak in 2003. In these experiments, Ampligen was administered to mice prior to and shortly after infection. The Company believes that Ampligen may provide similarly effective prophylaxis against COVID-19, as both coronaviruses are extremely similar in key regulatory RNA sequences essential for coronaviral replication."
Ampligen has a well-developed safety profile based on approximately 100,000 IV doses administered to humans and is ready to deploy for clinical trials in China if trials are approved by the PRC authorities and if Ampligen is authorized for export under the FDA regulations governing the export of investigational drugs for use in a sudden and immediate national emergency. (See: "Ampligen as an Antiviral," safety slides 7-15, at https://aimimmuno.com/events-presentations/).
ChinaGoAbroad CEO Jesse T H Chang states: "Ampligen has the potential to be a groundbreaking life-saving protective therapy. This drug may be useful for doctors, nurses, healthcare professionals, first responders and people exposed to the virus. Without better protection, infected professionals in our medical teams may continue to become martyrs on the frontlines of the battle against this highly contagious virus. If Ampligen works in the clinic against COVID-19 the same way it worked in the SARS experiments, a protective drug such as Ampligen - unlike a mask and gloves - would provide immunological protection from the inside. For those inadvertently exposed to the virus, it may provide hope against infection or development of the disease. Such a protective therapy would also become an important public health tool against exposed people spreading the disease. We are excited and indeed honored to work with AIM ImmunoTech on this endeavor so important to the Chinese people."
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.
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, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of the Coronavirus in humans and no assurance can be given that it will be the case. The presentation and stockholders' letter referenced in this press release refer to a number of studies. No assurance can be given that future studies will not result in findings that are different from those reported in the referenced studies. This press release related to potential activity in China. Operating in foreign countries such as China carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential operations in China will not be adversely affected by these risks. 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. 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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