Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

Sly Saint · Oct 25, 2022

Several posts have been moved from this thread:
Ampligen - Hemispherx Biopharma re ME/CFS

not relating to ME but Covid-19
AIM ImmunoTech inks deal to research vaping device as a vehicle for Ampligen to treat coronavirus

AIM believes Ampligen has potential as a prophylactic/early-onset therapeutic against the coronavirus (COVID-19). The drug showed 100% preclinical efficacy against the viral infection in a mouse trial, and it has been generally well tolerated when administered nasally to humans.

The agreement allows AIM to conduct research in China on the efficacy of the Smoore inhalation device as a delivery method for Ampligen.
Click to expand...

https://www.proactiveinvestors.com/...for-ampligen-to-treat-coronavirus-916966.html

Sly Saint · Jun 11, 2020

AIM ImmunoTech Files Provisional Patent Application for the Use of Ampligen(R) as a Potential Therapy for COVID-19 Induced Chronic Fatigue

Jun 11, 2020 2:05 PM GMT+1
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 / ACCESSWIRE / 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."
Click to expand...

https://www.morningstar.com/news/ac...-therapy-for-covid-19-induced-chronic-fatigue

John Mac · Oct 13, 2020

AIM ImmunoTech Announces IRB Approval to Enroll COVID-19 ‘Long Haulers’ in the AMP-511 ME/CFS Clinical Trial of Ampligen COVID-19 Patients May Continue to Experience Chronic Fatigue-Like Symptoms

OCALA, Fla., Oct. 06, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) is pleased to announce that it has received Institutional Review Board (IRB) approval for the expansion of the AMP-511 Expanded Access Program (EAP) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. Patients in the trial are treated with AIM’s flagship pipeline drug Ampligen.

These patients — commonly referred to as Post-COVID-19 Chronic Fatigue (PCCF) / “Long Haulers” because of the persistence of their symptoms — will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. Up to 20 of the 100 active participants can be Long Haulers, according to the new trial protocol amendment. AIM is currently preparing the IRB-approved protocol for submission to the U.S. Food and Drug Administration (“FDA”).

"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,” according to Charles Lapp, MD, a global expert in ME/CFS. “The investigational immune-modulating antiviral drug Ampligen might have a role to play in this scenario.”
Click to expand...

https://www.biospace.com/article/re...-to-experience-chronic-fatigue-like-symptoms/

Sly Saint · Oct 24, 2020

AIM Trial Moves Ahead, And Other News: The Good, Bad And Ugly Of Biopharma

AIM ImmunoTech reports IRB go ahead for AMP-511 clinical trial
AIM ImmunoTech Inc. (NYSEMKT:AIM) announced that Institutional Review Board has given its approval for the expansion of the AMP-511 Expanded Access Program clinical trial for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome using Ampligen. The new approval will allow the company to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms.
Click to expand...

Under the new trial protocol amendment, out of the 100 active participants, up to 20 participants may be the ‘Long Haulers’. These are the patients who have persistent symptoms. The company is currently working to prepare the protocol for submission to the US FDA. A large number of survivors of the first SARS-CoV-1 epidemic in 2003 kept reporting typical chronic fatigue-like symptoms after recuperating from the acute illness. It is estimated that nearly 27 percent of survivors display chronic fatigue syndrome as per the CDC criteria.
Click to expand...

https://seekingalpha.com/article/43...ahead-and-news-good-bad-and-ugly-of-biopharma

RedFox · Oct 25, 2022

Merged thread

AIM ImmunoTech Announces FDA Clearance of IND Application to Evaluate Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

AIM Immunotech will be doing a Phase 2 trial of Ampligen for long Covid fatigue. Here is a press release from the company:

AIM ImmunoTech Announces FDA Clearance of IND Application to Evaluate Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

Key quotes:

AIM ImmunoTech Inc....today announced its Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) may proceed to initiate a Phase 2 study evaluating its investigational drug, Ampligen, as a therapeutic for patients with post-COVID conditions (“AMP-518”).

“We are very pleased to be able to proceed with our Phase 2 study and are prepared to advance Ampligen as a potential therapeutic for the treatment of myalgic encephalomyelitis/chronic fatigue (ME/CFS)-like post-COVID conditions, an exploding area of significant unmet medical need,” commented Thomas K. Equels, MS JD, Chief Executive Officer of AIM. “Post-COVID-19 Disabling Fatigue, along with other debilitating post-COVID conditions such as ‘Brain Fog’, continue to affect tens of millions of people worldwide.

“We expect to commence enrollment in early 2023.”

The planned Phase 2 study is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in patients experiencing the post-COVID condition of fatigue.

Approximately 80 subjects between the ages of 18 to 60 years old are expected to be enrolled across up to 10 centers in the United States.
Click to expand...

RedFox · Oct 13, 2022

Solve ME has also covered this:

Breaking News: FDA clears Ampligen to start a clinical trial in Long Covid

A decade after the U.S. Food and Drug Administration (FDA) did not approve Ampligen (rintatolimod) for the treatment of ME/CFS, this antiviral and immuno-modulator drug is getting a rare second chance.

Ampligen’s developer AIM ImmunoTech, a biotech company focused on the research and development of therapeutics, announced today that the FDA has given a green light to their Investigational New Drug (IND) application for a Phase 2 study of Ampligen for the treatment of Post-Covid conditions (Long Covid). The study will focus on the key symptom of fatigue, as well as cognitive dysfunction (“brain fog”) and sleep disturbance.
Click to expand...

FMMM1 · Oct 13, 2022

Haven't looked at link etc. yet.

Interesting to see what folks think of this development.

I think this may be interesting as pre-Covid some of the people on the trial would have been received an ME/CFS diagnosis - correct?
If the trial is detailed then a small number of people improving, i.e. who would (pre-Covid) have been diagnosed with "ME/CFS", would be of interest to the ME/CFS community.

Thoughts?

BrightCandle · Oct 13, 2022

It wasn't well tolerated in ME/CFS patients a lot of people had side effects. The biggest problem is the trial length of 12 weeks and potentially dosage. One of the problems is the effect waned over a few months and no amount of jostling the drug dose seemed to help. Ignoring that problem already exposed in me patients IMO is a fatal flaw of the study design and while it might show efficacy it will hide that it also stops working.

Just in general I think we need to see 6 and 12 month followups on all long haul and me/cfs drug trials due to the way the disease seems to get better then worse again.

RedFox · Oct 13, 2022

I always heard Ampligen had a pretty benign safety profile. I think this is a positive development. If it gets approved for LC it will see immediate, widespread off-label use in ME, but that doesn't mean it will work.

CRG · Oct 13, 2022

After almost 50 years rintatolimod is still a cure in search of a disease.

Dolphin · Oct 15, 2022

I haven’t read this properly but it might be of interest to those who follow the topic.

Source: Globe NewsWire
Date: October 13, 2022
URL:
https://www.globenewswire.com/news-...misses-AIM-s-Baseless-Section-13-d-Claim.html

U.S. District Court dismisses AIM's 'baseless' Section 13(d) claim
------------------------------------------------------------------
* Court Rules that Allowing Claim to Proceed Would be Inconsistent with
Statutory Purpose of Investor Protection
* AIM's Stock Price Continues Dramatic Decline, Closing at New 52-Week
Low of $0.479 on October 12, 2022, Down More Than 35% Since July 18,
2022 When AIM Filed the Now Dismissed Lawsuit Against ASFV Committee
* Worried AIM Board Selectively Discloses Incomplete Information
Regarding Pending Delaware Action in Attempt to Distract from Failures

RedFox · Oct 16, 2022

That sounds like fairly typical investing stuff. Often when a small publicly traded company performs poorly, there will be big fights between "activist" shareholders (those who want to play an active role in how the company is run) and company leadership.

Edit: Cort Johnson covers this in more detail. In reality, it looks like there were a lot of legal battles because their earlier leadership was incompetent.

CRG · Oct 15, 2022

RedFox said: ↑

That sounds like fairly typical investing stuff. Often when a small publicly traded company performs poorly, there will be big fights between "activist" shareholders (those who want to play an active role in how the company is run) and company leadership.
Click to expand...

So it would seem. A partial list:

https://bergermontague.com/cases/hemispherx-biopharma-inc-securities-litigation/
https://casetext.com/case/hemispherx-biopharma-v-bioclones
https://www.lawyersandsettlements.com/lawsuit/hemispherx-biopharma-inc-heb-securities-2.html
https://www.bigclassaction.com/lawsuit/hemispherx-biopharma-inc-heb-securities.php
https://caselaw.findlaw.com/us-11th-circuit/1055767.html
https://www.biospace.com/article/re...ils-in-multi-million-dollar-federal-lawsuit-/
https://www.paed.uscourts.gov/documents/opinions/99D0197P.pdf

https://en.wikipedia.org/wiki/AIM_ImmunoTech

One take from the investor side might be "this is a company with a bag of magic beans to sell, so what has been the medium term return on magic beans ?" Also "what's the tax break on magic bean R&D ?"

RedFox · Oct 16, 2022

Cort Johnson covers the trial, along with a history of Ampligen and AIM ImmunoTech, in Health Rising:
Longtime ME/CFS Drug Ampligen Gets Its Shot with Long COVID

Cort Johnson said:

Numerous add-on effects from long COVID have been anticipated – insights into chronic fatigue syndrome (ME/CFS), new treatment possibilities, increased funding – but I don’t know if anyone really thought this one would pan out. Ampligen (rintatolimod) is a unique drug in ME/CFS history: it’s still the only drug that ever attempted to get FDA approval to treat ME/CFS. It popped up early in the ME/CFS saga, made a lot of waves – prompted the publication of two books including an at times hilarious fictionalized account of the trials, Patient 002, was even written about it – and then it faded.
Click to expand...

Sly Saint · Oct 25, 2022

Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions

https://clinicaltrials.gov/ct2/show/NCT05592418

RedFox · Oct 25, 2022

Sly Saint said: ↑

Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions

https://clinicaltrials.gov/ct2/show/NCT05592418
Click to expand...

Provides more detail that what was announced in the media. A few things stick out. The study will only run for 12 weeks or ~3 mo. The main outcome measure is the Promis Fatigue scale. I haven't found a full version online, but a short version is available. Patients must meet the Fukuda criteria, so this is more like a study on chronic fatigue than ME/CFS by the modern definition. Completion expected January 2024.

While the applicability of this study to ME is limited, I predict that if Ampligen is approved for long Covid, we will see immediate, widespread off-label use for ME, for better or worse.

RedFox · Apr 13, 2023

AIM ImmunoTech Announces Central IRB Approval of Phase 2 Study Protocol Evaluating Ampligen® for the Treatment of Post-COVID Conditions
https://www.tmcnet.com/usubmit/2023/04/04/9788662.htm

OCALA, Fla., April 04, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, today announced central Institutional Review Board (“IRB”) approval for the protocol of its Phase 2 study evaluating Ampligen® as a therapeutic for patients with post-COVID conditions (“AMP-518”). With this approval in hand, AIM is moving forward with the start-up process for the study’s planned clinical sites.
Click to expand...

They've gotten approval from the group that reviews studies' ethics. The estimated start date on clinicialtrials.gov is March, so hopefully, they're starting very soon. Completion is expected next January.

Dolphin · Apr 13, 2023

RedFox said: ↑

AIM ImmunoTech Announces Central IRB Approval of Phase 2 Study Protocol Evaluating Ampligen® for the Treatment of Post-COVID Conditions
https://www.tmcnet.com/usubmit/2023/04/04/9788662.htm

They've gotten approval from the group that reviews studies' ethics. The estimated start date on clinicialtrials.gov is March, so hopefully, they're starting very soon. Completion is expected next January.
Click to expand...

Good to see that they are not messing around with open-label trials as they have sometimes done in the past. This looks more useful e.g.

The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in patients experiencing the post-COVID condition of fatigue. The primary outcome measure of the study is change from baseline to week 13 in PROMIS® Fatigue Score. Other study outcomes include: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to weeks 6 and 13 in distance traveled during a Six-Minute Walk Test; proportion of subjects that surpass 54 meters in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to weeks 6 and 13 in PROMIS® Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS® Sleep Disturbance Score.
Click to expand...

Jaybee00 · Jul 4, 2023

https://twitter.com/user/status/1676046890180198402

RedFox · Jul 10, 2023

AIM ImmunoTech Enrolls and Doses First Subject in Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions
https://aimimmuno.com/aim-immunotec...n-for-the-treatment-of-post-covid-conditions/

AIM ImmunoTech said:

AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced it has enrolled and dosed the first subject in the company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions (“AMP-518”). This important study milestone follows on the heels of the company having recently opened multiple clinical study sites and having screened numerous subjects. Study screening is ongoing and AIM expects to dose additional new subjects in the coming weeks. For more information about AMP-518, please visit ClinicalTrials.gov and reference identifier NCT05592418.
Click to expand...

They're off and running now!

Log in or Sign up

Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

Sly Saint Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

John Mac Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

FMMM1 Senior Member (Voting Rights)

BrightCandle Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

CRG Senior Member (Voting Rights)

Dolphin Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

CRG Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

Dolphin Senior Member (Voting Rights)

Jaybee00 Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

Share This Page

Log in or Sign up

Ampligen in Phase 2 Clinical Study for the Treatment of Post-COVID Conditions

Sly Saint Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

John Mac Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

FMMM1 Senior Member (Voting Rights)

BrightCandle Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

CRG Senior Member (Voting Rights)

Dolphin Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

CRG Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

Sly Saint Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

Dolphin Senior Member (Voting Rights)

Jaybee00 Senior Member (Voting Rights)

RedFox Senior Member (Voting Rights)

Share This Page

Useful Searches