AIM ImmunoTech and Shenzhen Smoore Technology Announce an Agreement to Research Utilizing an Innovative Smoore Inhalation Delivery Device and Ampligen (rintatolimod) as a Potential, Easy-To-Use Treatment Approach for the SARS-CoV-2 Pandemic

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OCALA, FL / ACCESSWIRE / April 6, 2020 / AIM ImmunoTech AIM today announced it has entered into a Material Transfer and Research Agreement (MTA) with Shenzhen Smoore Technology Limited. According to a market survey report by Frost & Sullivan, Smoore is the world's largest vaping device manufacturer in terms of revenue in 2019, whose products include, but are not limited to, high-tech inhalation devices. The purpose of the MTA is to research in China the efficacy of Smoore's inhalation delivery device using Ampligen, AIM's flagship drug, which has been approved in Argentina for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and is experimental through Phase 3 clinical trials in the United States. AIM believes Ampligen has potential as a prophylactic/early-onset therapeutic against COVID-19, the disease caused by SARS-CoV-2.

AIM's pluripotent Toll Like Receptor 3 (TLR3) agonist, Ampligen, has established pre-clinical 100% protective efficacy against SARS-CoV-1 viral infection in U.S. National Institutes of Health-contracted animal experimentation (see: Day 2009 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787736/] and Barnard 2006 [https://journals.sagepub.com/doi/abs/10.1177/095632020601700505]) and AIM has human safety data (see: Overton 2014 https://www.sciencedirect.com/science/article/pii/S0264410X14010457?via%3Dihub) showing Ampligen to be generally well tolerated when administered intranasally to humans.

"All this leads to the strong hypothesis, which AIM and Smoore jointly seek to prove through this experimental program. We believe that Ampligen, when administered deep into the lungs at the first signs of the disease via the Smoore device - designed to carefully distribute different-sized particles of Ampligen - may initiate a therapeutic TLR3 response throughout the upper and lower respiratory system that will stop the SARS-CoV-2 virus in its tracks," states AIM CEO Thomas K. Equels. "Smoore is without question one of the world's leading innovators of inhalation technology. We are excited and eager to test Ampligen using Smoore's advanced inhalation device. If we can make the administration of Ampligen as easy as vaping and delivering nicotine, and testing proves Ampligen has COVID-19 efficacy as a prophylaxis, then this combination has the potential to be a powerful and easily self-administered tool in the global effort to stop the COVID-19 pandemic."

"As the world's largest vaping device manufacturer in terms of revenue in 2019 and global leader in offering vaping technology solutions with advanced R&D technology, we are excited to have this opportunity to work with AIM in exploring the medical inhalation of Ampligen in the fight against the COVID-19 pandemic. We believe conventional medical inhalation devices can be miniaturized and mass produced with better dosage and aerosol particle size control with our proprietary technology. With proper vaporization of Ampligen via an easy-to-use device, we see a potential to help more people in the world in combating the current COVID-19 pandemic," commented Dr. Zhiqiang Shi, Chief Science Officer of Smoore.

AIM Chief Science Officer David Strayer, MD, adds: "The clear goal of this research is to develop a self-administered inhalation device capable of safely delivering an Ampligen atomized mist deep into the pulmonary airways. We believe this approach may have potential as a prophylactic/early-onset therapeutic 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 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 COVID-19 in humans and no assurance can be given that it will be the case. In addition, no assurance can be given that future pre-clinical or clinical trials will be successful, nor that they will lead to a successful treatment or treatment delivery system. The safety and efficacy of the use of the Smoore technology with Ampligen has not been previously established, and that is the purpose of this experimental collaboration. No assurance can be given that future studies will not result in findings that are different from those reported in the referenced studies. 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. 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.

Contacts:

Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com

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AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com

SOURCE: AIM ImmunoTech Inc



View source version on accesswire.com:

https://www.accesswire.com/583967/AIM-ImmunoTech-and-Shenzhen-Smoore-Technology-Announce-an-Agreement-to-Research-Utilizing-an-Innovative-Smoore-Inhalation-Delivery-Device-and-Ampligen-rintatolimod-as-a-Potential-Easy-To-Use-Treatment-Approach-for-the-SARS-CoV-2-Pandemic

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