(It appears there is a push for Ampligen)
June 23, 2016
Ampligen has been in the FDA pipeline for so many years that it almost seems like a mirage at this point. The ME/CFS community has been praying, hoping, believing that Ampligen will be its first FDA approved drug for over twenty years. For a lot of people that hope may have died, but the drug has gotten new life recently.
While there were some problems with the trials the drug did meet several important endpoints including increasing time on a treadmill and increased oxygen utilization. It should be noted that Ampligen has tried to move the needle on probably the most difficult factor of all to budge in ME/CFS: oxygen utilization during exercise.
Any drug providing clinical benefit to 30-40% of a population which has no approved drugs should be a slam dunk. (Less effective drugs have been readily approved in other illnesses). Hopefully, with new leadership, Hemispherx’s twenty plus year journey to bring Ampligen to market will end successfully, and the ME/CFS community will finally get its first drug approved.
Francis Collins will think your question is quite stupid, better think of another one for him.
Don;t like my answer? Maybe you should ask Francis Collins - he's the one considering an ampligen trial.
In a recent interview, Collins described the range of possibilities under discussion. “They’re talking about everything from basic science – the metabolome, microbiome, immune system, imaging – to clinical trials for promising approaches, including Ampligen and Rituximab,” Dr. Collins said.
Let us know what Collins says you pofs.
Why would I explain anything to a hedgie?
2 posts | Last Activity: 1 minute 13 seconds ago
Member since: Jun 17, 2016
By Courtney Alexander Miller
NIH is asking the ME/CFS community what future research should be done. Below is a request to have NIH fund clinical trials for ME/CFS starting with Ampligen, as the only medication close to approval in the FDA pipeline. If you want to add your name to this request, the deadline is midnight Thursday, 6/23. Some organizations and dozens of patients have signed onto it, but we would like to show NIH how important treatment studies are to our community. The text of our response is below.
To join the letter, email your name, years ill, and state to Courtney Miller at firstname.lastname@example.org and tell us you wish to join the Ampligen letter.
Note: this is separate from the RFI as produced by the survey, and has been undertaken by Courtney Miller rather than by #MEAction as an entity.
For additional information about Ampligen in ME/CFS, visit the MEpedia page on Ampligen.
Response to Notice Number: NOTNS16024
Request for Information: Soliciting Input for New Research Strategies for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
NIH should immediately fund a small, wellpowered clinical trial to demonstrate efficacy of Ampligen for treatment of ME/CFS patients or a subset thereof, soliciting applications in 2016 from clinicians experienced in treating patients with Ampligen. The trial should be doubleblind, placebocontrolled, demonstrating efficacy and characterizing responders.
Additionally, NIH should solicit applications for new clinical trials of promising medications for treatment of ME/CFS, such as rituximab, antivirals, monoclonal antibodies, and crosspurposed treatments from similar diseases like Multiple Sclerosis.
Google the subject for the supporting discussion
Wow, Hello AstraZenica???, we have the solution to your problem with flumist.!!!
Possibly another transaction point JJ?
Well, clearing the slate on the company as a whole, will not hurt any type of transaction, imo :) It appears the main transaction types now are Ampligen for CFS, Ampligen for Cancer and Alferon manufacturing.
Cancer is a real wild card here - HEB is very proud about something, I'm dying to hear from Kalinski - that could entice a big to take on both CFS and manufacturing. Ah the possibilities.
Kiani oversaw the state of the art alferon manufacturing re-do - but he is now gone - so that opens the way for a big, with even more expertise. I'd think a big would be VERY interested in that plant. It is incredible.
I think part of the tidying up is a gov't requirement that HEB do everything it can to attract a private partner... before the NIH can justify spending millions on an NIH sponsored Ampligen trial. Taxpayers money after all. Very interested to see how it plays out.
What a big fat liar.
The Trans-NIH ME/CFS Working Group will review the comments about ME/CFS research that they receive from the public and potentially use this information to direct current and future research.
rituximab appears much LESS promising.
This is the NIH ASKING for your input an RFI (Request For Information)
On May 24th, the National Institutes of Health (NIH) released the document Request for Information: Soliciting Input for New Research Strategies for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). An RFI, or Request for Information is “critical for identification and consideration of research areas and topics to be included in future efforts.” The Trans-NIH ME/CFS Working Group will review the comments about ME/CFS research that they receive from the public and potentially use this information to direct current and future research.
OK longs, another chance for you to be pro-active. This is on #meactions wiki if you want to search.
Hemispherx Biopharma has written this email for people to copy and paste asking the NIH to study Ampligen in a clinical trial. Feel free to change or personalize. (Do not include any personal information you wish to remain confidential.)
Must be submitted by Friday, June 24, 2016.
Please send to: MECFSRFI@mail.nih.gov
Subject line: RFI response: Research Needs/Opportunities ME/CFS
Body of Email
NIH should fund and direct a Phase IV clinical trial of Ampligen for the treatment of ME/CFS.
ME/CFS is a severely debilitating, chronic and complex disease. Considered a public health crisis, it is a critical unmet medical need with a severe lack of funding; we recommend a Phase IV study be conducted by the NIH granted under a conditional approval by the FDA and in collaboration with the support of the sponsor. The recommendation fulfills NIH/FDA’s goal to speed new treatments to patients announced in 2010*.
• A description of the need or opportunity Currently there is no approved drug therapies for ME/CFS, however Ampligen provides a most unique opportunity to advance a treatment, further understand the disease and open the regulatory doors for other pharmaceutical companies to pursue drug development. No other therapy has advanced this far in the FDA pipeline. New drug therapies entering the pipeline may take another decade before approval. FDA regulations permit conditional approval of drugs and their collaborative initiative with NIH offers the pathway conduct the study.
• A scientific rationale and potential health impact
Iraj Kiani is Carter's wife???? William Carter will be surprised to hear that,
i1dumbo is a complete idiot.
LOL, the hedgies are too funny.... and so transparent.
It's no secret that Carter was reluctant to take on big partners - getting burned by Dupont. It's no secret that Carter wanted HEB to be the next Pfizer and do everything in house - Equels said as much recently.
And now it's no secret that big partners are interested in HEB.
Too bad for you hedgies. lol
"This 'belt and suspenders’ approach is intended to provide comfort to future development partners that any rights Dr. Carter may have had in our intellectual property portfolio have been fully assigned by Dr. Carter."