Ampligen - Hemispherx Biopharma re ME/CFS

thought this might be of interest:

https://www.s4me.info/threads/a-con...gue-syndrome-1994-strayer-cheney-et-al.13854/

 

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

 

I haven’t read but perhaps of interest to someone:

Source: Globe NewsWire
Date: October 24, 2022
URL:
https://www.globenewswire.com/news-...red-Through-Discovery-in-Delaware-Action.html


ASFV committee reveals troubling statements made by entrenched AIM board uncovered through discovery in Delaware action

 

For what it is worth:
Open label trial


AIM ImmunoTech Announces Phase 2 Study of Ampligen® for the Treatment of Pancreatic Cancer is Open and Recruiting Patients
Ongoing efforts to open additional clinical sites for recruitment at premier cancer centers across the U.S. and Europe are in progress to facilitate patient enrollment and dosing
February 28, 2023 08:45 ET

| Source: AIM ImmunoTech Inc.

https://www.globenewswire.com/news-...c-Cancer-is-Open-and-Recruiting-Patients.html

 

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.

 

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.