Ampligen for ME/CFS

Hemispherx also has an Expanded Access Program for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the United States and an Early Access Program for ME/CFS in Europe. Hemispherx is conducting AMP-511, wherein the FDA has authorized compassionate care for up to 100 subjects. Further, Hemispherx is preparing a manuscript for publication clearly identifying a subset with a high response rate to Ampligen. See: ClinicalTrials.gov.
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https://finance.yahoo.com/news/hemi...JO4V2GRSU63y0xOKjJB_kIIC16c8Og-4zKCoarxlGyk6R
 
Hemispherx Biopharma, Inc. Changes Name to AIM ImmunoTech Inc. Reflecting Ampligen’s® Immuno Modulation Progress in Ongoing Oncology Clinical Trials and ME/CFS
Aug 23
Announces new ticker symbol ‘AIM' effective September 3, 2019
OCALA, Fla., Aug. 23, 2019 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), an immuno-tech company focused on the research and development of immunological agents to treat multiple types of cancers and immune-deficiency diseases, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), today announced that it has changed its name to AIM ImmunoTech Inc. effective September 3, 2019. Additionally, the Company announced that effective September 3, 2019, the Company's ticker will change to "AIM."
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"Amplified Immunological Modulation — or ‘AIM' — is what our company is all about. We are delighted to announce this name change, which we believe better reflects the core mission of the Company — developing synergistic immunological agents in the fields of lethal cancers and severe ME/CFS. We are a small company, fighting hard to bring meaningful cures to sick people currently without hope. Our AIM is to help others by advancing immunology and unlocking the human body's ability to heal itself, in both ME/CFS and in highly lethal malignancies," said CEO Thomas K. Equels. "Further, I am very proud of our extensive clinical pipeline and cost-effective approach. We believe the fact that all our oncology trials are paid for by third-party entities through grants from government, NGOs and leading pharmaceutical companies provides significant validation of our clinical potential and a de facto de-risking of the programs."
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https://www.nasdaq.com/press-releas...ng-ampligens-immuno-modulation-20190823-00164
 
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AIM ImmunoTech to Present at the 21st Annual Rodman & Renshaw Global Investment Conference in New York City on September 10th

Read more: http://www.digitaljournal.com/pr/4436902#ixzz5ykQqbKo5
September 6, 2019 / AIM ImmunoTech Inc. (NYSE American:AIM), an immuno-tech company focused on the research and development of immunological agents to treat multiple types of cancers and immune-deficiency diseases, such as myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), today announced that it will be presenting at the 21st Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC, being held on September 8-10, 2019 at the Lotte New York Palace Hotel in New York City. Thomas K. Equels, Chief Executive Officer, is scheduled to present on Tuesday, September 10, 2019 at 3:25 p.m. Eastern Time.
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When the presentation is complete it will be available for viewing at http://wsw.com/webcast/hcw5/aim.
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https://finance.yahoo.com/news/aim-...HOczG7N0iZ40OYi3zGYtdR7aC0T9mgyE_hDMm2FFAH5v4
 
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AIM ImmunoTech's Ampligen Receives Clearance from FDA for Exportation to Argentina for the Treatment of Severe Chronic Fatigue Syndrome
http://aimimmuno.irpass.com/ViewEmail.asp?b=2265&id=183751&p=2169290&I=1201116-E6Z6D3a5b9

AIM ImmunoTech Inc. Announces the U.S. Department of Defense's Award of $6.42M to Roswell Park Comprehensive Cancer Center to Study Ampligen as Part of a New Treatment of Brain-Metastatic Breast Cancer
https://aimimmuno.irpass.com/AIM-Im...ses-Award-of-642M-to-Roswell-Park-Comprehensi

AIM ImmunoTech Inc. Announces a Second DoD Award, This One of $8.3 Million, to Fund Phase 2 Clinical Trial to Study Ampligen as Part of a New Treatment for Brain-Metastatic Breast Cancer at the Moffitt Cancer Center
https://aimimmuno.irpass.com/AIM-Im...e-of-83-Million-to-Fund-Phase-2-Clinical-Tria
 
You'll find this interesting - especially for those who were not around for the AdCom meetings of 2012-13. Maybe it can be used to petition the FDA.

"Never mind that Hemispherx had demonstrated that the log transformation data was not warranted or that non transformed data was appropriate …the FDA was mostly interested in whether the biostatistician had ‘followed the rules’. It was a bizarre thing as a patient to watch a drug that could help ill people be held up on procedural issues but there it was."

https://onbiostatistics.blogspot.com/2020/01/pre-specifications-of-statistical.html
 
And a recent PR related to Ampligen and CFS/ME.

AIM ImmunoTech Provides Update on Commercial Launch of Ampligen(R) in Argentina for the Treatment of Chronic Fatigue Syndrome

Receives clearance from Argentina's FDA to import first shipment of Ampligen® for commercial sale in Argentina

AIM 'sets sights' on treating COVID-19 induced chronic fatigue in Argentina

https://aimimmuno.irpass.com/ViewEmail.asp?b=2265&id=190760&p=2176912&I=1201116-E6Z6D3a5b9
 
For what it is worth:

OCALA, Fla., March 06, 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, including COVID-19, the disease caused by the SARS-CoV-2 virus, today issued a letter to stockholders highlighting key accomplishments in 2022 and outlining corporate objectives for 2023.

The full text of the letter is as follows:

March 6, 2023
https://www.globenewswire.com/news-...ImmunoTech-Issues-Letter-to-Stockholders.html
 
https://www.globenewswire.com/news-...gen-with-Issuance-of-Two-Key-U-S-Patents.html

AIM ImmunoTech Bolsters Intellectual Property Estate for Ampligen® with Issuance of Two Key U.S. Patents
November 27, 2023 09:05 ET| Source: AIM ImmunoTech Inc.

Extends certain exclusive U.S. rights to Ampligen for cancer and ME/CFS through 2039

Management discusses patent issuance and what this means in a brief video: here

OCALA, Fla., Nov. 27, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent No. 11,813,279 and 11,813,281 for Ampligen® titled “Compositions for cancer therapy and methods,” and “Methods for improving exercise tolerance in myalgic encephalomyelitis patients,” respectively.

AIM Chief Executive Officer Thomas K. Equels stated: “Our ongoing effort to expand and solidify AIM’s global intellectual property estate is a foundational component of our development strategy for Ampligen. AIM’s expectation for Ampligen — both as a therapeutic for people suffering from dire diseases and as a valuable asset for our stockholders — is the driving force behind our multiple clinical studies in oncology, ME/CFS and Post-COVID conditions. These two new U.S. patents will serve to further strengthen the potential financial future of our company by extending certain sole rights to Ampligen and for these uses to 2039.”

Click here to watch a brief video from the AIM management team discussing the issuance of the U.S. patents and what it means for the pipeline development strategy for Ampligen®.


[..]

ME/CFS Patent

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating condition characterized by extreme fatigue, pain, and cognitive issues. The Centers for Disease Control and Prevention (CDC) estimates that between 836,000 and 2.5 million Americans suffer from ME/CFS. Addressing these severe symptoms has been a complex challenge for healthcare professionals. However, the issuance of U.S. Patent No. 11,813,281 represents a major leap forward, bringing new hope to those impacted by the enduring and debilitating symptoms of ME/CFS.

The novel methods outlined in the new patent claims involve, at least, identifying individuals who have experienced ME/CFS symptoms for 2 to 8 years — a feature identified through extensive research — and treating these symptoms by administering Ampligen. This precision in treatment timing reflects a targeted, cutting-edge approach to personalized medicine in ME/CFS care and is expected to lead to significant improvements and effectiveness in ME/CFS symptoms in this population.

U.S. Patent No. 11,813,281 bestows AIM ImmunoTech Inc. with the sole rights to exclude others from practicing the claimed methods of treating ME/CFS symptoms using Ampligen until January 12, 2040. This exclusivity fortifies AIM's position in the market by enabling development of a distinctive and unparalleled treatment option. Additionally, the patent paves the way for strategic alliances and licensing deals, endowing AIM with the unique opportunity to conduct further research and development of the claimed method, either independently or with licensed partners, to continue refining and enhancing this patented treatment method.
 
Dolphin said:
https://www.globenewswire.com/news-...gen-with-Issuance-of-Two-Key-U-S-Patents.html

AIM ImmunoTech Bolsters Intellectual Property Estate for Ampligen® with Issuance of Two Key U.S. Patents
November 27, 2023 09:05 ET| Source: AIM ImmunoTech Inc.

Extends certain exclusive U.S. rights to Ampligen for cancer and ME/CFS through 2039

Management discusses patent issuance and what this means in a brief video: here

OCALA, Fla., Nov. 27, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent No. 11,813,279 and 11,813,281 for Ampligen® titled “Compositions for cancer therapy and methods,” and “Methods for improving exercise tolerance in myalgic encephalomyelitis patients,” respectively.

AIM Chief Executive Officer Thomas K. Equels stated: “Our ongoing effort to expand and solidify AIM’s global intellectual property estate is a foundational component of our development strategy for Ampligen. AIM’s expectation for Ampligen — both as a therapeutic for people suffering from dire diseases and as a valuable asset for our stockholders — is the driving force behind our multiple clinical studies in oncology, ME/CFS and Post-COVID conditions. These two new U.S. patents will serve to further strengthen the potential financial future of our company by extending certain sole rights to Ampligen and for these uses to 2039.”

Click here to watch a brief video from the AIM management team discussing the issuance of the U.S. patents and what it means for the pipeline development strategy for Ampligen®.


[..]

ME/CFS Patent

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating condition characterized by extreme fatigue, pain, and cognitive issues. The Centers for Disease Control and Prevention (CDC) estimates that between 836,000 and 2.5 million Americans suffer from ME/CFS. Addressing these severe symptoms has been a complex challenge for healthcare professionals. However, the issuance of U.S. Patent No. 11,813,281 represents a major leap forward, bringing new hope to those impacted by the enduring and debilitating symptoms of ME/CFS.

The novel methods outlined in the new patent claims involve, at least, identifying individuals who have experienced ME/CFS symptoms for 2 to 8 years — a feature identified through extensive research — and treating these symptoms by administering Ampligen. This precision in treatment timing reflects a targeted, cutting-edge approach to personalized medicine in ME/CFS care and is expected to lead to significant improvements and effectiveness in ME/CFS symptoms in this population.

U.S. Patent No. 11,813,281 bestows AIM ImmunoTech Inc. with the sole rights to exclude others from practicing the claimed methods of treating ME/CFS symptoms using Ampligen until January 12, 2040. This exclusivity fortifies AIM's position in the market by enabling development of a distinctive and unparalleled treatment option. Additionally, the patent paves the way for strategic alliances and licensing deals, endowing AIM with the unique opportunity to conduct further research and development of the claimed method, either independently or with licensed partners, to continue refining and enhancing this patented treatment method.
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So, this seems like a helpful step. But, are they actually planning on doing more research? Ampligen seems like it may actually help, if I understand correctly. It would be so good to have a treatment available clinically, but that seems very far off.
 
Merged thread

AIM ImmunoTech Announces Charles Lapp, MD, as a Consulting Medical Officer for its ME/CFS and Long COVID Programs

OCALA, Fla., April 15, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced that Charles Lapp, MD, is joining the company to help lead its efforts to develop Ampligen (rintatolimod) as a potential treatment for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Long COVID.

https://finance.yahoo.com/news/aim-immunotech-announces-charles-lapp-125500232.html
 
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Some sentences that mention Ampligen

They [the board] delivered zero material process on any of the key clinical indications of Ampligen, failing to advance even a single company-sponsored study to completion.
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We have the resources, networks, and credibility to successfully raise the necessary funds and provide the essential runway to finally create value for stockholders and invest in the future of Ampligen.
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  • Ampligen in Argentina – We will examine whether regulatory and operational efforts can be expedited to launch commercial sales, potentially creating meaningful revenues in the short term.
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They seem to mention wanting to prioritise researching the potential of Ampligen in Oncology.

I haven’t really followed Ampligen much. If it finally makes it to Argentina, will there likely be a phase 4 trial?
 
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