Skip to main content

AIM ImmunoTech Announces Ethics Committee Approval to Commence Phase 1 Clinical Study of Ampligen as an Intranasal Therapy

-

 February 16, 2021 09:15 ET

OCALA, Fla., Feb. 16, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of AIM’s drug Ampligen as an intranasal therapy, a critical step in the company’s ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases.

Earlier this year, the company announced that it had entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) trial. Last week, approval was received from the Dutch local Ethics Committee, clearing the road for execution of the trial.

The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. This will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.

“We are delighted and honored to receive Ethics Committee approval, an important step toward initiation of the trial,” said AIM CEO Thomas K. Equels. “We are on track for site initiation later this month and expect to begin enrolling participants in the study during the first quarter of 2021. Importantly, our prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage concentrations. As a result, we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19 and are excited to commence safety tests of potential dosing regimens.”

Dr. Matthijs Moerland, principal investigator at CHDR: “We’re very happy helping AIM with this important step. Together with AIM’s study team, we feel we have not only designed a trial evaluating Ampligen’s intranasal safety profile, but also yielding important mechanistic data on the compound’s immunomodulatory activities.”

Popular Posts in the Last 7 Days

Consciousness of Guilt in Science and Medicine (From Perplexity A.I.)

-
  Develop the idea that there is something in science and medicine called "consciousness of fraud" (like consciousness of guilt) and list the telltale signs that a scientist is inadvertently showing it. The concept of "consciousness of fraud" in science and medicine parallels legal "consciousness of guilt," reflecting subtle behavioral and linguistic cues that betray a researcher's awareness of misconduct. These involuntary signs manifest through writing patterns, methodological choices, and professional behavior, often revealing attempts to conceal fabricated or manipulated data. Below are key telltale signs, synthesized from empirical studies and expert analyses of scientific fraud: 🔍 Linguistic and Writing Patterns Obfuscation in Language: Fraudulent papers use significantly more jargon, abstract terms, and complex phrasing to obscure methods or results. This "linguistic masking" aims to deter scrutiny, with fraudulent texts containing ~1...
Read more
-
Transplant Complications Bone marrow supression Colitis/diarrhea Delirium/CNS Dysfunction Encephalitis/Amnesia GVHD Hemophagocytic syndrome Hepatitis /Liver failure Pneumonitis Transplant Reactivation Overview Encephalitis Encephalitis / Meningitis Overview Encephalitis in the Immunocompromised Encephalitis in the Immunocompetent Rhomboencephalitis Limbic Encephalitis Encephalomyelitis Amnesia Rash & Roseola Seizures Febrile Seizures Status Epilepticus Cognitive Dysfunction Delirium Amnesia Hypersensitivity (DIHS/DRESS) Drug Induced Hypersensitivity Syndrome (DIHS) Drug Reaction with Eosinophilia & Systemic Symptoms (DRESS) Stevens-Johnson Syndrome (SJS) Immune Suppression Bone Marrow Suppression Lymphadenopathy/Fever Possible Disease Associations Multiple Sclerosis Chronic Fatigue Syndrome Epilepsy Mesial/Temporal Lobe Epilepsy Status Epilepticus Colitis/Diarrhea Endocrine D...
Read more

We asked Perplexity A.I. to make the argument that Castleman's Disease undermines the nosology, epidemiology, and virology of AIDS.

-
 From Perplexity A.I. Make the argument that Castleman's Disease undermines the nosology, epidemiology, and virology of AIDS. Castleman disease, particularly its HIV-associated multicentric form (HIV-MCD), challenges core paradigms in AIDS medicine across nosology, epidemiology, and virology. Below is a detailed analysis of how this rare lymphoproliferative disorder complicates established frameworks. 🧬 Nosological Challenges HIV-MCD disrupts traditional AIDS classification by: Blurring diagnostic boundaries: It exhibits inflammatory symptoms (e.g., fever, cytopenia) and histopathology (plasmablastic proliferation) that overlap with—but are distinct from—classic AIDS-defining conditions like lymphoma or opportunistic infections. Dual-pathogen dynamics: Diagnosis requires confirming HHV-8 co-infection, positioning it as a viral co-pathogenesis rather than a direct HIV complication. This contrasts with AIDS nosology, which typically centers on HIV as the primary etiological agent. U...
Read more

Popular Post in the Last 30 Days

Consciousness of Guilt in Science and Medicine (From Perplexity A.I.)

-
  Develop the idea that there is something in science and medicine called "consciousness of fraud" (like consciousness of guilt) and list the telltale signs that a scientist is inadvertently showing it. The concept of "consciousness of fraud" in science and medicine parallels legal "consciousness of guilt," reflecting subtle behavioral and linguistic cues that betray a researcher's awareness of misconduct. These involuntary signs manifest through writing patterns, methodological choices, and professional behavior, often revealing attempts to conceal fabricated or manipulated data. Below are key telltale signs, synthesized from empirical studies and expert analyses of scientific fraud: 🔍 Linguistic and Writing Patterns Obfuscation in Language: Fraudulent papers use significantly more jargon, abstract terms, and complex phrasing to obscure methods or results. This "linguistic masking" aims to deter scrutiny, with fraudulent texts containing ~1...
Read more
-
Transplant Complications Bone marrow supression Colitis/diarrhea Delirium/CNS Dysfunction Encephalitis/Amnesia GVHD Hemophagocytic syndrome Hepatitis /Liver failure Pneumonitis Transplant Reactivation Overview Encephalitis Encephalitis / Meningitis Overview Encephalitis in the Immunocompromised Encephalitis in the Immunocompetent Rhomboencephalitis Limbic Encephalitis Encephalomyelitis Amnesia Rash & Roseola Seizures Febrile Seizures Status Epilepticus Cognitive Dysfunction Delirium Amnesia Hypersensitivity (DIHS/DRESS) Drug Induced Hypersensitivity Syndrome (DIHS) Drug Reaction with Eosinophilia & Systemic Symptoms (DRESS) Stevens-Johnson Syndrome (SJS) Immune Suppression Bone Marrow Suppression Lymphadenopathy/Fever Possible Disease Associations Multiple Sclerosis Chronic Fatigue Syndrome Epilepsy Mesial/Temporal Lobe Epilepsy Status Epilepticus Colitis/Diarrhea Endocrine D...
Read more

We asked Perplexity A.I. to make the argument that Castleman's Disease undermines the nosology, epidemiology, and virology of AIDS.

-
 From Perplexity A.I. Make the argument that Castleman's Disease undermines the nosology, epidemiology, and virology of AIDS. Castleman disease, particularly its HIV-associated multicentric form (HIV-MCD), challenges core paradigms in AIDS medicine across nosology, epidemiology, and virology. Below is a detailed analysis of how this rare lymphoproliferative disorder complicates established frameworks. 🧬 Nosological Challenges HIV-MCD disrupts traditional AIDS classification by: Blurring diagnostic boundaries: It exhibits inflammatory symptoms (e.g., fever, cytopenia) and histopathology (plasmablastic proliferation) that overlap with—but are distinct from—classic AIDS-defining conditions like lymphoma or opportunistic infections. Dual-pathogen dynamics: Diagnosis requires confirming HHV-8 co-infection, positioning it as a viral co-pathogenesis rather than a direct HIV complication. This contrasts with AIDS nosology, which typically centers on HIV as the primary etiological agent. U...
Read more

If the establishment decides that the nosology of AIDS is wrong and HIV is not the cause of AIDS could that be considered a Black Swan event?

-
 From Perplexity A.I.  If the establishment decides that the nosology of AIDS is wrong and HIV is not the cause of AIDS could that be considered a Black Swan event? If the scientific establishment were to fundamentally revise the current understanding of AIDS and declare that HIV is not the cause, this would indeed constitute a Black Swan event—an extremely rare, unpredictable, and highly consequential occurrence that dramatically alters conventional wisdom and scientific consensus. A Black Swan event is defined by its rarity, profound impact, and the tendency for people to rationalize it retrospectively as if it could have been expected. The current scientific consensus, established in the late 1980s and reinforced by overwhelming evidence, is that HIV is the causative agent of AIDS. This consensus is based on decades of research, clinical experience, and the effectiveness of HIV-targeting treatments. If the establishment were to reverse this consensus, it would be unpreceden...
Read more

Are any endogenous retroviruses reactivated in AIDS and do any of them act like superantigens?

-
From Perplexity A.I. Are any endogenous retroviruses reactivated in AIDS and do any of them act like superantigens? Yes, several human endogenous retroviruses (HERVs) are reactivated in AIDS, particularly during HIV infection, and some evidence suggests that certain HERV proteins may have superantigen-like activity. Reactivation of HERVs in AIDS/HIV Infection HERV-K (HML-2) is the most studied family and is consistently shown to be upregulated in HIV-infected cells and patients. HIV infection increases HERV-K RNA and protein expression in various cell lines (e.g., U-87 MG, H9 T cells, MT2, Jurkat) and primary CD4+ T cells, often in a dose- and time-dependent manner. Other HERV families such as HERV-E, HERV-W, ERV-9, and subgroups of HERV-K (HML-3, HML-4, HML-10) are also upregulated in HIV infection. The HIV-1 Tat protein plays a key role in activating HERV expression by transactivating HERV-K long terminal repeats (LTRs), opening chromatin structure, and inducing transcription factors...
Read more

Popular Posts from the Last Year

Oral Kaposi's Sarcoma looks like the Crimson Crescents in Chronic Fatigue Syndrome patients.

-
Image
This is what oral Kaposi's Sarcoma looks like. Source:  https://doctorspiller.com/kaposis-sarcoma/ Compare it to these crimson crescent lesions in the mouths of Chronic Fatigue Syndrome patients. "Burke A. Cunha, MD, discovered what he called crimson crescents in the mouths of 80% of his CFS patients. After the word got out, Cunha received calls from other parts of the country. Physicians began telling him that they also were finding the crimson crescents in their patients once they looked for them." https://www.prohealth.com/library/crimson-crescents-facilitate-chronic-fatigue-syndrome-cfs-diagnosis-11266 Chronic Fatigue Syndrome patients may have undiagnosed internal Kaposi's Sarcoma. Susan Levin found HHV-8, the Kaposi's Sarcoma virus, in half of CFS patients she looked at. Prevalence in the Cerebrospinal Fluid of the Following Infectious Agents in a Cohort of 12 CFS Subjects Susan Levine Published online: 04 Dec 2011 ABSTR...
Read more

Dr. Bhupesh Prusty and Professor Thomas Rudel discuss their HHV-6 research

-
Image
https://hhv-6foundation.org/cihhv-6/the-activation-of-cihhv-6-by-telomeric-circle-formation-qa-with-dr-bhupesh-prusty Tweet If you have Amazon Prime or Kindle Unlimited, you can immediately begin reading The Chronic Fatigue Syndrome Epidemic Cover-up and you will soon understand why the facts about the Chronic Fatigue Syndrome epidemic have been hidden from the public for almost four decades. Click here to begin reading Or purchase a print copy for only $20 shipped by Amazon Prime  If you want to know the truth about the Chronic Fatigue Syndrome epidemic, you need to discover the reporting of Neenyah Ostrom. For a decade, starting in 1988, Ostrom reported on Chronic Fatigue Syndrome for a newspaper called New York Native . What her reporting uncovered about the true nature of the Chronic Fatigue Syndrome epidemic will shock you.                                 ...
Read more

Dr. Rebecca Culshaw Smith's book is discussed on Twitter

-
  #AIDS #HIV #Truvada #TruvadaVictims #ClassAction An eye-opening, heart-breaking investigation. Dr. Rebecca Culshaw Smith's groundbreaking book exposes the tragic reality of 26,000 plaintiffs suing Gilead over the toxic side effects of HIV drug Truvada. https://t.co/PHVoKrafcU pic.twitter.com/hbh3mN4tdI — MyBookLists (@mybooklists) September 12, 2024
Read more

Is African Swine Fever a threat to human health in Congo?

-
Image
https://pmc.ncbi.nlm.nih.gov/articles/PMC7045278/ Our prior reporting on African Swine Fever ASF contaminated meat not entirely safe Besides, ASF-contaminated food could not be entirely safe for humans. “According to the latest research, though the virus is not dangerous to humans, there are documented reactions [of human bodies to ASF] in the form of production of antibodies against it. This indicates an ASF attempt to infect the body and the possibility of a serious weakening of the immune system,” Pavlov said. From 2018 ASF Russia: consumers want liability for sellers of contaminated meat (pigprogress.net) African Swine Fever is a big story already because, when and if it spreads to all of Western Europe and China, it will cause the collapse of a major portion of the agricultural export economies of the affected countries. We're talking about many billions of dollars of losses. And the problem is not temporary because those countries will be suspected of harboring the disease ...
Read more

All Time Most Popular Posts

Dr. Bhupesh Prusty and Professor Thomas Rudel discuss their HHV-6 research

-
Image
https://hhv-6foundation.org/cihhv-6/the-activation-of-cihhv-6-by-telomeric-circle-formation-qa-with-dr-bhupesh-prusty Tweet If you have Amazon Prime or Kindle Unlimited, you can immediately begin reading The Chronic Fatigue Syndrome Epidemic Cover-up and you will soon understand why the facts about the Chronic Fatigue Syndrome epidemic have been hidden from the public for almost four decades. Click here to begin reading Or purchase a print copy for only $20 shipped by Amazon Prime  If you want to know the truth about the Chronic Fatigue Syndrome epidemic, you need to discover the reporting of Neenyah Ostrom. For a decade, starting in 1988, Ostrom reported on Chronic Fatigue Syndrome for a newspaper called New York Native . What her reporting uncovered about the true nature of the Chronic Fatigue Syndrome epidemic will shock you.                                 ...
Read more

Anthony Fauci was part of the gang that silenced and destroyed Judy Mikovits.

-
Image
Read the interview in which Judy Mikovits called Chronic Fatigue Syndrome "Non-HIV AIDS." https://www.prohealth.com/library/plague-an-interview-with-judy-mikovits-32911   If you have Amazon Prime or Kindle Unlimited you can immediately begin reading this book. If you have Amazon Prime or Kindle Unlimited, you can immediately begin reading The Chronic Fatigue Syndrome Epidemic Cover-up and you will soon understand why the facts about the Chronic Fatigue Syndrome epidemic have been hidden from the public for almost four decades. Click here to begin reading Or purchase a print copy for only $20 shipped by Amazon Prime  This is the book causing heated debates about Chronic Fatigue Syndrome and HHV-6, "The Fifty Shades of AIDS Virus," in laboratories, doctor's offices, and homes all over the world.                                         ...
Read more

Is Chronic Fatigue Syndrome the other AIDS epidemic in the gay community?

-
Image
https://www.gscene.com/news/new-doctors-guidelines-for-severe-me/ On April 16, 1996, Congressman Jerrold Nadler spoke on the floor of Congress about his request for a General Accounting investigation into how the CDC had handled the Chronic Fatigue Syndrome epidemic. Nadler did that at the urging of Charles Ortleb, the publisher and the New York Native and his reporter Neenyah Ostrom. Ortleb and Ostrom had made the case to Nadler that Chronic Fatigue Syndrome and the virus it had been linked to, HHV-6, were serious public health issues.                                                 In an interview in New York Native with Neenyah Ostrom,Congressman Nadler said, "Congress can mandate research into CFS as a viral disease. Maybe it will turn out that HHV-6A is the cause of CFS; maybe it will turn out that other viruses are involved. But Con...
Read more

Was Judy Mikovits destroyed because her XMRV work would have ultimately shown HIV is a total fraud?

-
Image
How much HIV research can be replicated? Is the whole field of AIDS build on HIV pseudoscience that cannot be replicated? We need an HIV replication movement that demands it all be replicated. We need to know if HIV is a solid as XMRV. How has HIV helped hide the epidemic of Chronic Fatigue Syndrome which has been called "Non-HIV AIDS"? Read this book if you want to know the whole story. Available now on Amazon here .
Read more