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==History== AmpligenĀ® was based on a double-stranded RNA ([[Double-stranded RNA viruses|dsRNA]]) compound developed by the pharmaceutical company, Merck, in the 1960s, as a potential cancer drug. Though effective in the petri dish, the original compound proved to be too toxic for human use.<ref name=":2">{{Cite web | url = http://pomerantzlawfirm.com/assets/complaints/hemispherx.pdf | title=FRATER VS HEMISPHERX BIOPHARMA, Case 2:12-cv-07152-WY | last = | first = | author-link = | date = 2013-05-20 | website = Pomerantz Law Firm|archive-url=|archive-date= | access-date = 2019-09-26}}</ref><ref>{{Cite web | url = https://phoenixrising.me/treating-cfs-chronic-fatigue-syndrome-me/immune/antivirals-and-immunemodulators/ampligen-rintatolimod/ampligen-i-effectiveness | title = Ampligen I: Effectiveness | website = Phoenix Rising|language=en-US | access-date = 2019-09-26}}</ref> [[William Carter | William A. Carter]], MD, a researcher at Johns Hopkins University, was able to modify the compound in the 1970s to reduce its toxicity (see section below on "Mechanism of action"). The new compound was named AmpligenĀ®, short for āAMPLIfied GENetic activity.ā In the 1980s, while a researcher at Hahnemann University in Philadelphia, Dr. Carter obtained the license for the compound from Johns Hopkins University. He and several other researchers at Hahnemann University affiliated with a small company, Hemispherx, now called AIM ImmunoTech, to manufacture it.<ref name=":2" /> In the late 1980s, AIM ImmunoTech partnered with Dupont to start clinical trials for AmpligenĀ®. After a couple years, Dupont severed its business relationship with AIM ImmunoTech.<ref>{{Cite web | url = https://phoenixrising.me/treating-cfs-chronic-fatigue-syndrome-me/immune/antivirals-and-immunemodulators/ampligen-rintatolimod/ampligen-part-ii-twisted-history | title = Twisted History: Ampligen and CFS | website = Phoenix Rising|language=en-US | access-date = 2019-09-26}}</ref> Through the years, Dr. Carter's confidence in AmpligenĀ®'s ability to stimulate the body's immune system lead to him offering the drug as a treatment for a variety of diseases including cancer, AIDS, [[chronic fatigue syndrome]], [[hepatitis C]], [[Gulf War Illness]], [[Influenza A virus subtype H1N1|swine flu]], and [[Ebola virus disease|ebola]].<ref>{{Cite web | url = http://www.bio-medicine.org/medicine-technology/Hemispherx-Presents-Evidence-of-Ampligen-Synergies-with-Existing-0AAntivirals-at-International-Avian-Influenza-Conference-453-1/ | title = Hemispherx Presents Evidence of Ampligen Synergies with Existing,Antivirals at International Avian Influenza Conference ( PARIS--(BUSINESS WIRE)--Jun 4 2007 - H...) | website = bio-medicine.org | access-date = 2019-09-26}}</ref><ref>{{Cite web | url = https://www.marketwatch.com/story/tiny-biotech-says-it-may-have-an-answer-for-ebola-2015-02-02 | title = Tiny biotech says it may have an answer for Ebola | last = Britt | first = Russ | website = MarketWatch|language=en-US | access-date = 2020-02-04}}</ref> AIM ImmunoTech stated: "...we believe that AmpligenĀ® may have broad-spectrum anti-viral and anti-cancer properties."<ref>{{Cite web | url = https://aimimmuno.com/ | title = Home | last = ImmunoTech | first = A. I.M. | website=AIM ImmunoTech Inc.|language=en-US | access-date = 2019-09-26}}</ref> This over-confidence resulted in a class action suit by stockholders in 2013.<ref name=":2" /> Testing for efficacy in [[ME/CFS]] started in 1990 and continues to the present (see section below on "Drug approval status"). Testing for other conditions has been sporadic. In 2016, the University of Pittsburgh was sponsoring Phase I/II studies using AmpligenĀ® as an adjunct treatment in ovarian, peritoneal, and colorectal cancer.<ref>{{Cite web | url = https://aimimmuno.com/pipeline/ | title = Pipeline | last = ImmunoTech | first = A. I.M. | website=AIM ImmunoTech Inc.|language=en-US | access-date = 2020-02-04}}</ref><ref>{{Cite web | url = https://aimimmuno.com/1568-2/ | title = Hemispherx Issues 2019 Second Quarter Report Citing Strong Steady Progress in Cancer Clinical Trials | last = ImmunoTech | first = A. I.M. | date = 2019-08-15 | website = AIM ImmunoTech Inc.|language=en-US | access-date = 2019-11-20}}</ref> Hahnemann University and AIM ImmunoTech are collaborating on Phase II studies for AmpligenĀ® as a single agent for renal cell carcinoma and melanoma. Georgia Regents University is in the preclinical stage of testing AmpligenĀ® as part of a combination therapy for colorectal cancer and melanoma.<ref name="Crystal, 2016" /> In late fall 2015, Dr. [[Francis Collins]] announced that the [[National Institutes of Health]] (NIH) was considering the possibility of sponsoring a clinical trial for AmpligenĀ®, as well as [[Rituximab]] and other treatments.<ref>{{Cite web | url = https://www.meaction.net/2015/12/21/nih-considering-ampligen-and-rituximab-trials/ | title = NIH considering Ampligen and Rituximab trials | date = 2015-12-21 | website = #MEAction|language=en-US | access-date = 2019-09-26}}</ref> By the end of 2016, the [[National Institutes of Health|NIH]] has not announced any further plans for a clinical trial for either drug. At the 12th International [[IACFS/ME]] Research and Clinical Conference in October 2016, representatives from AIM ImmunoTech announced "that a retrospective analysis of the AMP-516 Phase III trial of AmpligenĀ® in patients with [[CFS/ME|chronic fatigue syndrome/myalgic encephalomyelitis]] (CFS/ME), segmented primarily by disease duration, showed that 51% of AmpligenĀ® treated patients in a cohort with a disease duration of two to eight years vs. 18% of placebo patients demonstrated at least 25% improvement in placebo-adjusted exercise tolerance whereas the patient subset with less than two years or greater than eight years of disease duration failed to show a clinically-significant response."<ref>{{Cite web | url = http://www.globenewswire.com/news-release/2016/10/31/884673/0/en/Hemispherx-Biopharma-Announces-Identification-of-High-Responder-Patient-Subgroup-from-Ampligen-Phase-III-Trial-in-Patients-with-CFS-ME.html | title = Hemispherx Biopharma Announces Identification of High Responder Patient Subgroup from AmpligenĀ® Phase III Trial in Patients with CFS/ME | last = Inc | first = Hemispherx Biopharma | date = 2016-10-31 | website = GlobeNewswire News Room | access-date = 2019-09-26}}</ref>
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