AIM ImmunoTech AIM Stock News

AIM ImmunoTech Inc (NYSEAMERICAN: AIM) is flying in the market this morning, trading on gains of more than 30%. The gains started when the company said that it received approval from the United States Food and Drug Administration, or FDA, to begin a clinical trial in the COVID-19 space. Here’s what’s going on:

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AIM Stock Rockets On First Human COVID-19 Trial Approval

In the release, AIM ImmunoTech said that the FDA has authorized a trial assessing the safety and effectiveness of Ampligen in combination with interferon alfa-2b, in cancer patients with COVID-19.

In the release, AIM said that the clinical trial will be conducted at Roswell Park Comprehensive Cancer Center. Dr. Pawel Kalinski, a pioneer in the development of the combination as a potential cancer treatment, and Dr. Brahm Segal, wil lead the trial.

The trial aims to assess the safety of this regimen among cancer patients with mild to moderate COVID-19. Moreover, the study will assess the extent to which the combination therapy promotes the clearance of the SARS-CoV-2 virus from the upper airway.

In the release, AIM said that the trial is expected to enroll 40 patients in two stages. The first stage of the study will include 12 to 24 patients. All patients will receive Ampligen in combination with interferon alfa-2b at escalating doses.

Once this phase is complete, more study participants will be enrolled and randomized into two arms. One arm will receive the two-drug combination and a control group will not receive Ampligen or interferon alfa, but will receive the best available care.

In the release AIM ImmunoTech said that in the years following the SARS-CoV-1 epidemic, studies of mouse models of the condition showed that Ampligen created a protective effect. In fact, in this sister strain of the virus causing today’s pandemic, Ampligen reduced virus lung titers to below detectable limits and led to more rapid decline of virus in the lungs compared to untreated animals.

Importantly, in these animal studies, all treated animals survived, as opposed to a 100% death rate among the control group. With such positive results in SARS-CoV-1, many expected that results will be similar while treating SARS-CoV-2.

In a statement, Dr. David Strayer, CSO at AIM, had the following to offer:

We are extremely pleased that Dr. Kalinski and his team at Roswell Park have obtained FDA authorization to initiate this combinational study using Ampligen in combination with interferon for cancer patients with COVID-19. Historically, Ampligen was shown to have synergistic antitumor and antiviral activity when combined with human interferons in studies published in the 1980s. A clinical study was conducted using Ampligen in combination with interferon in patients with solid tumors. The study showed that the combination was generally well-tolerated. AIM announced February 11, 2020, the filing of three provisional patent applications surrounding Ampligen for use against COVID-19. These applications cover the use of Ampligen, both alone and in combination with interferon as an early onset therapy for COVID-19. Further, we filed for Ampligen as a proposed intranasal coronavirus vaccine enhancer that would combine Ampligen with inactive SARS-CoV-2. At AIM, we believe that Ampligen has the potential to play several important roles in the war against COVID-19.

The above statement was followed up by the CEO of AIM ImmunoTech, Thomas K. Equels. Here’s what he had to say:

Since this January, when we filed our provisional patent applications, we have been focused on advancing Ampligen as a potential treatment for COVID-19 and believe Ampligen has significant therapeutic potential as both an early-onset treatment and prophylaxis against this new and deadly virus. Dr. Segal, Dr. Kalinski and their teams at Roswell Park, with genius and creativity in this pandemic, are focused on saving the lives of cancer patients. Roswell deserves great credit for exploring the important and potentially life-saving role of Ampligen in cancer patients with COVID-19, a patient population they are dedicated to serving. AIM is very pleased to see that the FDA has authorized this human study at Roswell Park to conduct research on Ampligen in combination with interferon alfa as a possible antiviral treatment for COVID-19 for high risk cancer patients.

Following the results of this trial, we hope to expand tests of Ampligen to other high risk and immunocompromised COVID-19 groups as the death rate in these groups is often five to seven times higher than the general population. Ampligen has an extremely well developed safety profile, which is based on more than 100,000 IV doses administered to humans, and has shown minimal side effects in multiple clinical trials which makes it an acceptable drug candidate for study in vulnerable patient populations.

This News Is Huge

There’s no denying the fact that the news released by AIM ImmunoTech this morning is great news. The COVID-19 pandemic is continuing to create issues. However, those that come up with viable treatments could come out of this thing as big winners.

With the company’s work to show that its combination treatment will improve outcomes for cancer patients with COVID-19, AIM is taking a step in the right direction. This study will do two things.

First, it will show us if the combination treatment can effectively assist patients with both cancer and COVID-19, which is an important population to protect. However, if all goes well, chances are that we will see use of Ampligen in patients that have COVID-19, but do not have cancer. Considering the effects of Ampligen on SARS-CoV-1, it only makes sense that the treatment will be a positive one to fight against today’s SARS-CoV-2.

Of course, if the study shows positive results and Ampligen is approved, alone or in combination, as a treatment for COVID-19, the revenue potential here is incredible. As such AIM stock should be on your watchlist.

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