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There seems to be some disagreement between sources... [1] suggests that phase III clinical trials have been completed. while another part of their website [2] suggests they are currently enrolling, in agreement with the government clinical trials website, [3]. If anyone could shed some light on this, it would be welcome. Thedreamdied 17:47, 27 January 2007 (UTC)
The entire Ampligen entry is incorrect and needs to be rewritten by a specialist —The preceding unsigned comment was added by Zanzibarlo ( talk • contribs).
At what point does one concede that this company has been a huge fraud for many many years? It is now the end of the second quarter of 2007 and still no indication of when an NDA will be filed. Instead, we hear about a small flu trial in Australia. I will not even try to change web site but I think that the fact that this company is fraudulant, in my opinion, should be much more strongly emphasized. What if it is the Year 2010 and we still have no NDA submission?
Dr. Schweitzer lost access to the drug in February, 2008, because the principal investigator at the practice where she received the drug died, and FDA required the submission of a new request for permission for an open-label study. The re-submission was rejected, and there is no site within a two hour radius to receive the drug. After having gone from a Karnovsky 30 (basically bedridden and requiring a wheelchair) to a Karnovsky 70 (needing daily assistance but able to walk, read, write, and drive), she is now sliding backwards into invalidism. ---- Alicesfriend —Preceding unsigned comment added by Alicesfriend ( talk • contribs) 03:39, 18 September 2008 (UTC)
This topic is in need of attention from an expert on the subject. The section or sections that need attention may be noted in a message below. |
I feel that the entire 'Mechanism of Action' section is a bit confusing/weak and probably misleading/wrong. Perhaps you could help out? Thedreamdied 22:09, 29 January 2007 (UTC)
The entire Ampligen entry is incorrect and needs to be rewritten by a specialist. —The preceding unsigned comment was added by Zanzibarlo ( talk • contribs).
Blanking the article is unhelpful: and suggesting that "The entire Ampligen entry is incorrect and needs to be rewritten by a specialist" with the explanation "It was for the greater part incorrect, misleading and biased" is unhelpful - where is it incorrect, where is it misleading, and why is it biased? Feel free to correct any errors you see, with valid sources. Thedreamdied 23:12, 9 February 2007 (UTC)
Your contribution contains big mistakes (e.g. Ampligen phase III trial for CFS was completed in 2004, Bioclones' marketing rights are being challenged by Hemispherx Biopharma, Ampligen raw materials are no longer manufactured by Ribotech) and lacks relevant indispensable elements (e.g. the results of the phase II and phase III trials for Ampligen for CFS, relevant Ampligen patents)while containing a lot of irrelevant material (patent to infuse tobacco ). The serious side-effects you refer to lack correct evidence. The link you offer is a testimony of one person who cannot even prove that her problems were caused by Ampligen... I consider you lack the necessary competences and knowledge to write a serious article about Ampligen. It's a hopeless task to correct all the mistakes and the set-up of this entry, so someone should start from scratch. Wamper 11:12, 12 February 2007 (UTC)
Well, as I don't feel called upon to contribute, let me suggest you to compare the Wikipedia Ampligen entry with the information in the following fairly dependable research report http://www.boenningandscattergood.com/research/CI/HEB%20%282006.12.1%29.pdf and in the Sec filings of Hemispherx Biopharma http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000946644&owner=include As Ampligen is an experimental drug, I would wait for an EMEA European Public Assessment Report (EPAR) http://www.emea.eu.int/htms/human/epar/eparintro.htm or FDA equivalent Wamper 14:18, 12 February 2007 (UTC)
I have nevertheless tried to correct some errors and have added a number of useful references. The original entry was a blot on Wikipedia. Wamper 10:34, 13 February 2007 (UTC)
I have given it the try, please check it out, as I'm not sure it is OK. Wamper 13:23, 13 February 2007 (UTC)
For all citations, a separate entry in the References section is required. I added one citation with a template as footnote, but maybe you prefer to stick with embedded citations, in which case the references need to be added separately another time. Tikiwont 10:32, 14 February 2007 (UTC)
I'm not sure its really that relevant to the article to have so much about it. Perhaps a 'Hemispherx Biopharma' article could be created, with an explanation of their controversial history? Thedreamdied 14:46, 14 February 2007 (UTC)
According to here, Ampligen is mainly for CFS as well as HIV, which is barely mentioned in the article. AMP 720 is listed here, and there seems to be quite a lot of info available generally. Thedreamdied 15:39, 14 February 2007 (UTC)
This article seems to be the subject of competing points of view, particularly in the "Controversy" section. If there are any knowledgeable, yet uninvolved, editors that could help check this article for adherence to Wikipedia's neutral point of view policy, that would be helpful. -- Ed ( Edgar181) 16:56, 29 June 2009 (UTC)
It's hardly neutral
"In June 2009, The Street alleged..." "The Street also alleged"
references to an individual Asensio is biased representing him as a reputable person whereas, he has been barred "from association with any NASD member in any capacity" ref: http://en.wikipedia.org/wiki/Manuel_P._Asensio "Asensio & Company has issued a research report on Hemispherx that contains a Strong Sell and Short Sell rating." ref: http://www.aegis.com/NEWS/PR/1999/PR990509.html
So there's no neutrality this entire section is being hijacked by persons of opposing views and could be rewritten with an unbiased taint and accurate references pertinent to "AMPLIGEN" —Preceding unsigned comment added by 97.101.138.235 ( talk) 23:54, 10 July 2009 (UTC)
Ward20 changed the lead from 'refused to approve' to 'refused marketing approval', but that doesn't seem to be what the source says. It just says they refused to approve it for treatment of CFS. -- sciencewatcher ( talk) 22:55, 12 February 2010 (UTC)
Google scholar gives 1350 hits for Ampligen in (and 80 for Rintatolimod) excluding patents and refs. This seems plenty to establish that this is actually a notable substance, whether or not the current refs are any good. JMiall ₰ 16:27, 15 April 2015 (UTC)
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This edit request by an editor with a conflict of interest was declined. |
Intro: These proposed changes has been rewritten/reworked and the content reviewed and vetted by scientific experts in an attempt to improve the accuracy and quality of the information, including correcting broken and obsolete references. As noted in various sections of this talk page, this page is in need of expert help, the page contains statements that are not really useful about rintatolimod, and some information that is incorrect and/or biased.
I propose the following changes. The current text proposed for deletion has been italicized. My comments are in CAPS. The new text is in regular font. If the proposed edits are approved, I will/can re-post the approved information in the wiki page and cite the references. Once this first section is reviewed, I have additional content to add I believe will be equally beneficial to this wiki page. I believe this new language is informative and provides useful information where the current page is a bit of a mess.
Introduction:
1ST AND 2ND PARAGRAPHS OF CURRENT TEXT TO BE DELETED: Rintatolimod, sold under the tradename Ampligen, is a medication intended for treatment of chronic fatigue syndrome.[1] However, there is only low-quality evidence that it can improve the ability to exercise.[1]- Reason for deletion: the second sentence if factually incorrect. If you read the article referenced, it clearly does not come to this conclusion and does not state this.
It is an immunomodulatory double stranded RNA drug synthesized in the 1970s and manufactured by Hemispherx Biopharma.[2]
Although Ampligen was cleared for use in Canada in 1997,[3] and obtained orphan drug status for treatment of CFS in the European Union in 2000,[4] it is so far without FDA approval, and therefore classed as experimental in the United States. In 2007, Hemispherx filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) to market and sell rintatolimod for the treatment of CFS,[5] but this was rejected in December 2009, because the FDA concluded that the two RCTs "did not provide credible evidence of efficacy"[6][7] and "because of clinical, statistical, clinical pharmacology, nonclinical, product quality, and facilities inspection deficiencies."[8] The FDA requested Hemispherx conduct at least one additional controlled trial to demonstrate efficacy in treating CFS. In August 2012, Hemispherx submitted further analyses of the original clinical trial data, but did not submit additional trials for review. Four months later, a committee of the FDA voted 8-5 against approval for rintatolimod, again citing insufficient data.[8]
THE CURRENT TEXT ABOVE IS TO BE REPLACED WITH THE FOLLOWING:
Rintatolimod (brand name Ampligen®) is a mismatched double stranded RNA (dsRNA). Rintatolimod activates Toll-Like Receptor 3 (TLR3), which results in transitory modulation of the cellular expression of hundreds of genes providing initial innate immune responses. Innate immunity provides initial resistance against invading viral pathogens and the later adaptive immune responses responsible for long term immunity. Among the genes responding to rintatolimod are the interferons (IFN) known to provide broad antiviral and growth inhibitory properties (Ref). Rintatolimod activates IFN induced proteins that require dsRNA for activity (e.g.- 2ʹ-5ʹ adenylate synthetase, protein kinase R). Rintatolimod’s gene inducing activity is limited to activation of TLR3 (restricted TLR3 agonist), which minimizes systemic inflammatory cytokine responses (see mechanism of action below). [1]
The branded product, Ampligen®, is owned and manufactured by Hemispherx Biopharma, Inc.[2](Ref)The properties of clinical grade rintatolimod and a molecular model of the activated rintatolimod:TLR3 dimer complex are summarized in Table 4.[1] Intellectual property for rintatolimod includes new form and substance patents in the US and Europe.[2] [2]
BluebirdHill5 ( talk) 20:57, 4 April 2017 (UTC) Hemispherx Biopharma, Inc. BluebirdHill5 ( talk) 19:02, 16 June 2017 (UTC)
References
This drug has been approved in Argentina for chronic fatigue syndrome (might just be severe Chronic fatigue syndrome). I added it on the CFS page but it got reverted due to the sources used and I can't find better ones. Perhaps someone here can find better, either way posting here to make you aware of content that may be worth adding. I believe overall the evidence isn't great for that particular use. Limited sources below.
Amousey ( talk) 15:04, 27 May 2020 (UTC)
I just updated url and formatted sources in the lead section, and marked a few dead links. I added copy re Canada and Argentina. I updated the official web site for Hemispherx in the lead as well. Lots of the refs are used only in the lead, which is not best form for Wikipedia. The lead is meant to highlight the article’s contents, so the refs ought to be somewhere in the article as well. I might copy a section of the lead into a new section on Status across the world. I am not usually editing articles on drugs, and do not know if there are special rules, like for the articles on diseases.
This article is rated C-class on Wikipedia's
content assessment scale. It is of interest to the following WikiProjects: | |||||||||||
|
Ideal sources for Wikipedia's health content are defined in the guideline
Wikipedia:Identifying reliable sources (medicine) and are typically
review articles. Here are links to possibly useful sources of information about Rintatolimod.
|
There seems to be some disagreement between sources... [1] suggests that phase III clinical trials have been completed. while another part of their website [2] suggests they are currently enrolling, in agreement with the government clinical trials website, [3]. If anyone could shed some light on this, it would be welcome. Thedreamdied 17:47, 27 January 2007 (UTC)
The entire Ampligen entry is incorrect and needs to be rewritten by a specialist —The preceding unsigned comment was added by Zanzibarlo ( talk • contribs).
At what point does one concede that this company has been a huge fraud for many many years? It is now the end of the second quarter of 2007 and still no indication of when an NDA will be filed. Instead, we hear about a small flu trial in Australia. I will not even try to change web site but I think that the fact that this company is fraudulant, in my opinion, should be much more strongly emphasized. What if it is the Year 2010 and we still have no NDA submission?
Dr. Schweitzer lost access to the drug in February, 2008, because the principal investigator at the practice where she received the drug died, and FDA required the submission of a new request for permission for an open-label study. The re-submission was rejected, and there is no site within a two hour radius to receive the drug. After having gone from a Karnovsky 30 (basically bedridden and requiring a wheelchair) to a Karnovsky 70 (needing daily assistance but able to walk, read, write, and drive), she is now sliding backwards into invalidism. ---- Alicesfriend —Preceding unsigned comment added by Alicesfriend ( talk • contribs) 03:39, 18 September 2008 (UTC)
This topic is in need of attention from an expert on the subject. The section or sections that need attention may be noted in a message below. |
I feel that the entire 'Mechanism of Action' section is a bit confusing/weak and probably misleading/wrong. Perhaps you could help out? Thedreamdied 22:09, 29 January 2007 (UTC)
The entire Ampligen entry is incorrect and needs to be rewritten by a specialist. —The preceding unsigned comment was added by Zanzibarlo ( talk • contribs).
Blanking the article is unhelpful: and suggesting that "The entire Ampligen entry is incorrect and needs to be rewritten by a specialist" with the explanation "It was for the greater part incorrect, misleading and biased" is unhelpful - where is it incorrect, where is it misleading, and why is it biased? Feel free to correct any errors you see, with valid sources. Thedreamdied 23:12, 9 February 2007 (UTC)
Your contribution contains big mistakes (e.g. Ampligen phase III trial for CFS was completed in 2004, Bioclones' marketing rights are being challenged by Hemispherx Biopharma, Ampligen raw materials are no longer manufactured by Ribotech) and lacks relevant indispensable elements (e.g. the results of the phase II and phase III trials for Ampligen for CFS, relevant Ampligen patents)while containing a lot of irrelevant material (patent to infuse tobacco ). The serious side-effects you refer to lack correct evidence. The link you offer is a testimony of one person who cannot even prove that her problems were caused by Ampligen... I consider you lack the necessary competences and knowledge to write a serious article about Ampligen. It's a hopeless task to correct all the mistakes and the set-up of this entry, so someone should start from scratch. Wamper 11:12, 12 February 2007 (UTC)
Well, as I don't feel called upon to contribute, let me suggest you to compare the Wikipedia Ampligen entry with the information in the following fairly dependable research report http://www.boenningandscattergood.com/research/CI/HEB%20%282006.12.1%29.pdf and in the Sec filings of Hemispherx Biopharma http://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0000946644&owner=include As Ampligen is an experimental drug, I would wait for an EMEA European Public Assessment Report (EPAR) http://www.emea.eu.int/htms/human/epar/eparintro.htm or FDA equivalent Wamper 14:18, 12 February 2007 (UTC)
I have nevertheless tried to correct some errors and have added a number of useful references. The original entry was a blot on Wikipedia. Wamper 10:34, 13 February 2007 (UTC)
I have given it the try, please check it out, as I'm not sure it is OK. Wamper 13:23, 13 February 2007 (UTC)
For all citations, a separate entry in the References section is required. I added one citation with a template as footnote, but maybe you prefer to stick with embedded citations, in which case the references need to be added separately another time. Tikiwont 10:32, 14 February 2007 (UTC)
I'm not sure its really that relevant to the article to have so much about it. Perhaps a 'Hemispherx Biopharma' article could be created, with an explanation of their controversial history? Thedreamdied 14:46, 14 February 2007 (UTC)
According to here, Ampligen is mainly for CFS as well as HIV, which is barely mentioned in the article. AMP 720 is listed here, and there seems to be quite a lot of info available generally. Thedreamdied 15:39, 14 February 2007 (UTC)
This article seems to be the subject of competing points of view, particularly in the "Controversy" section. If there are any knowledgeable, yet uninvolved, editors that could help check this article for adherence to Wikipedia's neutral point of view policy, that would be helpful. -- Ed ( Edgar181) 16:56, 29 June 2009 (UTC)
It's hardly neutral
"In June 2009, The Street alleged..." "The Street also alleged"
references to an individual Asensio is biased representing him as a reputable person whereas, he has been barred "from association with any NASD member in any capacity" ref: http://en.wikipedia.org/wiki/Manuel_P._Asensio "Asensio & Company has issued a research report on Hemispherx that contains a Strong Sell and Short Sell rating." ref: http://www.aegis.com/NEWS/PR/1999/PR990509.html
So there's no neutrality this entire section is being hijacked by persons of opposing views and could be rewritten with an unbiased taint and accurate references pertinent to "AMPLIGEN" —Preceding unsigned comment added by 97.101.138.235 ( talk) 23:54, 10 July 2009 (UTC)
Ward20 changed the lead from 'refused to approve' to 'refused marketing approval', but that doesn't seem to be what the source says. It just says they refused to approve it for treatment of CFS. -- sciencewatcher ( talk) 22:55, 12 February 2010 (UTC)
Google scholar gives 1350 hits for Ampligen in (and 80 for Rintatolimod) excluding patents and refs. This seems plenty to establish that this is actually a notable substance, whether or not the current refs are any good. JMiall ₰ 16:27, 15 April 2015 (UTC)
Hello fellow Wikipedians,
I have just added archive links to 2 external links on
Rintatolimod. Please take a moment to review
my edit. If necessary, add {{
cbignore}}
after the link to keep me from modifying it. Alternatively, you can add {{
nobots|deny=InternetArchiveBot}}
to keep me off the page altogether. I made the following changes:
When you have finished reviewing my changes, please set the checked parameter below to true to let others know.
This message was posted before February 2018.
After February 2018, "External links modified" talk page sections are no longer generated or monitored by InternetArchiveBot. No special action is required regarding these talk page notices, other than
regular verification using the archive tool instructions below. Editors
have permission to delete these "External links modified" talk page sections if they want to de-clutter talk pages, but see the
RfC before doing mass systematic removals. This message is updated dynamically through the template {{
source check}}
(last update: 5 June 2024).
Cheers.— cyberbot II Talk to my owner:Online 07:55, 18 January 2016 (UTC)
This edit request by an editor with a conflict of interest was declined. |
Intro: These proposed changes has been rewritten/reworked and the content reviewed and vetted by scientific experts in an attempt to improve the accuracy and quality of the information, including correcting broken and obsolete references. As noted in various sections of this talk page, this page is in need of expert help, the page contains statements that are not really useful about rintatolimod, and some information that is incorrect and/or biased.
I propose the following changes. The current text proposed for deletion has been italicized. My comments are in CAPS. The new text is in regular font. If the proposed edits are approved, I will/can re-post the approved information in the wiki page and cite the references. Once this first section is reviewed, I have additional content to add I believe will be equally beneficial to this wiki page. I believe this new language is informative and provides useful information where the current page is a bit of a mess.
Introduction:
1ST AND 2ND PARAGRAPHS OF CURRENT TEXT TO BE DELETED: Rintatolimod, sold under the tradename Ampligen, is a medication intended for treatment of chronic fatigue syndrome.[1] However, there is only low-quality evidence that it can improve the ability to exercise.[1]- Reason for deletion: the second sentence if factually incorrect. If you read the article referenced, it clearly does not come to this conclusion and does not state this.
It is an immunomodulatory double stranded RNA drug synthesized in the 1970s and manufactured by Hemispherx Biopharma.[2]
Although Ampligen was cleared for use in Canada in 1997,[3] and obtained orphan drug status for treatment of CFS in the European Union in 2000,[4] it is so far without FDA approval, and therefore classed as experimental in the United States. In 2007, Hemispherx filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) to market and sell rintatolimod for the treatment of CFS,[5] but this was rejected in December 2009, because the FDA concluded that the two RCTs "did not provide credible evidence of efficacy"[6][7] and "because of clinical, statistical, clinical pharmacology, nonclinical, product quality, and facilities inspection deficiencies."[8] The FDA requested Hemispherx conduct at least one additional controlled trial to demonstrate efficacy in treating CFS. In August 2012, Hemispherx submitted further analyses of the original clinical trial data, but did not submit additional trials for review. Four months later, a committee of the FDA voted 8-5 against approval for rintatolimod, again citing insufficient data.[8]
THE CURRENT TEXT ABOVE IS TO BE REPLACED WITH THE FOLLOWING:
Rintatolimod (brand name Ampligen®) is a mismatched double stranded RNA (dsRNA). Rintatolimod activates Toll-Like Receptor 3 (TLR3), which results in transitory modulation of the cellular expression of hundreds of genes providing initial innate immune responses. Innate immunity provides initial resistance against invading viral pathogens and the later adaptive immune responses responsible for long term immunity. Among the genes responding to rintatolimod are the interferons (IFN) known to provide broad antiviral and growth inhibitory properties (Ref). Rintatolimod activates IFN induced proteins that require dsRNA for activity (e.g.- 2ʹ-5ʹ adenylate synthetase, protein kinase R). Rintatolimod’s gene inducing activity is limited to activation of TLR3 (restricted TLR3 agonist), which minimizes systemic inflammatory cytokine responses (see mechanism of action below). [1]
The branded product, Ampligen®, is owned and manufactured by Hemispherx Biopharma, Inc.[2](Ref)The properties of clinical grade rintatolimod and a molecular model of the activated rintatolimod:TLR3 dimer complex are summarized in Table 4.[1] Intellectual property for rintatolimod includes new form and substance patents in the US and Europe.[2] [2]
BluebirdHill5 ( talk) 20:57, 4 April 2017 (UTC) Hemispherx Biopharma, Inc. BluebirdHill5 ( talk) 19:02, 16 June 2017 (UTC)
References
This drug has been approved in Argentina for chronic fatigue syndrome (might just be severe Chronic fatigue syndrome). I added it on the CFS page but it got reverted due to the sources used and I can't find better ones. Perhaps someone here can find better, either way posting here to make you aware of content that may be worth adding. I believe overall the evidence isn't great for that particular use. Limited sources below.
Amousey ( talk) 15:04, 27 May 2020 (UTC)
I just updated url and formatted sources in the lead section, and marked a few dead links. I added copy re Canada and Argentina. I updated the official web site for Hemispherx in the lead as well. Lots of the refs are used only in the lead, which is not best form for Wikipedia. The lead is meant to highlight the article’s contents, so the refs ought to be somewhere in the article as well. I might copy a section of the lead into a new section on Status across the world. I am not usually editing articles on drugs, and do not know if there are special rules, like for the articles on diseases.