New Atmosphere, New Vision: Gibson and Whittemore Kick Off Invest in ME Conference 2016
Mark Berry reports on Dr. Gibson's introduction and Dr. Whittemore's keynote speech, at the 11th Invest in ME International ME Conference in London.
Discuss the article on the Forums.

Ampligen: FDA Approval DENIED 12/1/2009

Discussion in 'General ME/CFS News' started by consuegra, Dec 1, 2009.

  1. parvofighter

    parvofighter Senior Member

    Devil's Advocate

    I'm going to play Devil's Advocate here.:D

    I do wonder whether the FDA rejection was in fact necessary, in fact essential in light of the recent XMRV findings. Keep in mind that determination of "Efficacy of Ampligen for treatment of Chronic Fatigue Syndrome" pre-October 8th 09 was done very differently, and with very different metrics from what one might use now, with the possibility of the potentially profound XMRV/XAND/ME/CFS link.

    And consider what many virologists have noted: if you provide therapeutics to patients with ME/CFS and find a reduction/elimination of the XMRV virus and its effects, then that is reverse (but compelling) evidence that the virus does in fact "cause" ME/CFS. The old Ampligen clinical studies didn't do that. And causality is the million-dollar question that we're dying to have answered. The "old" clinical studies of Ampligen in other words - by their unavoidable past exclusion of XMRV metrics to measure efficacy - would not have been as powerful as a repeat clinical study including XMRV pre/post metrics. So this FDA rejection might turn out to be a good thing for ME/CFS patients, and even for an Ampligen manufacturer.

    I'm not trying to be a Pollyanna here - and no, I'm not affiliated in any way with Hemispherx - but I can't help thinking that this FDA rejection might turn out to be good for the ME/CFS community. IF whoever owns the Ampligen patent (and that may or not end up to be Hemispherx) moves quickly to directly and credibly measure the effect of Ampligen on Canadian-criteria patients with ME/CFS. Yes, other ME/CFS subgroups, fibromyalgia, MS, prostate ca, might conceivably be included. But if I'm not mistaken what rigorous scientists are waiting for - before they get really excited about XMRV/ME/CFS - are clinical studies that closely match the criteria used by the Science researchers. So a re-do of clinical studies for Ampligen might help get rid of the ambiguity inherent in a fuzzy definition of ME/CFS patients. Get rid of that noise, eh?

    Given what we are learning about XMRV and its link with ME/CFS, a rigorous, credible, and relevant evaluation of any therapeutic's efficacy for patients with ME/CFS diagnosed by Canadian Diagnostic Criteria would HAVE to include measurement of the drug's effect on specific tests for XMRV. Unless of course XMRV proves to have nothing to do with ME/CFS - tho I highly doubt that.

    I don't dispute Hemispherx's dismal history - nor disturbing reports of safety considerations. So the safety studies should not be dismissed as trivial. However I suspect I'm not alone in remaining keenly interested in the progress of any and all evidence-based research on therapeutics for those of us stuck in the maw of ME/CFS. Particularly clinical studies that directly measure any therapeutic intervention's effect on XMRV titres, byproducts (eg. proteins), and of course clinical symptoms (eg. a la Canadian ME/CFS criteria).

    FYI you can hear - from the horse's mouth - about Hemispherx's proposed plans (assuming they stay solvent) in a podcast tomorrow (Thursday).
    Hemispherx Biopharma Announces Investor Conference Call

    Philadelphia, PA, Wednesday, December 02, 2009: Hemispherx Biopharma, Inc. (NYSE Amex: HEB) announces an investor update by teleconference on Thursday, December 3, 2009 at 10:00am EST. The update will cover regulatory status of its platform technology (Ampligen, Alferon-N, Alferon LDO), strategic partnering and other matters, followed by a Q and A period.

    To access the conference call:
    U.S. Callers: 800-348-5860
    International Callers: 973-528-0008
    Conference Entry Code: 27781

    This call will be webcast via the Companys website at:

    A digital replay of the call will be available until December 18th by calling:
    U.S. Callers: 800-332-6854
    International Callers: 973-528-0005
    Conference Entry Code: 27781
  2. dannybex

    dannybex Senior Member

    Devil's advocate... a good thing! :)

    It's just my understanding, from reading about it months ago, like back in August(?), that the "revised" study results showed back then that there was no statistical difference between the patients and controls, and that's why some are suggesting they knew six months ago that it wouldn't be approved, but kept up a charade in order to keep the stock price up.

    But that's just my foggy brained recollection. It could all be a dream.

    Or a nightmare... :eek:
  3. JayS

    JayS Senior Member

    After reading parvofighter's post I came back to this & unless I'm getting something very wrong this looks like it makes more sense?
  4. Cort

    Cort Phoenix Rising Founder

    Hemispherx's response to the FDA decision

    To: The CFS Patients, Advocacy Community and Healthcare Practitioners

    From: Dr. David Strayer
    Medical Director of Hemispherx Biopharma

    Re: FDA Response on Ampligen

    Hemispherx has received a complete response from the FDA in which the FDA requires one additional clinical study to show a convincing effect of Ampligen in the treatment of CFS and confirm the safety in the target population. The on-going open-label study (AMP 511) and the patients enrolled will continue under the current protocol.

    The FDA has provided Hemispherx with a clearly articulated set of recommendations to go forward. I would like to share with you the process we plan to go through with the agency in order to identify the most expeditious path to satisfy the requirements for the approval of the Ampligen NDA.

    We plan to schedule a meeting with the agency as quickly as possible in order to obtain additional guidance and clarification concerning a number of matters, including the design of this clinical trial. This will be an ongoing process with the agency.

    As part of this dialogue, we plan to evaluate the utility of a special protocol assessment from the agency in order to clearly delineate the clinical trial end points, the statistical methods to be utilized, and to obtain agreement with the agency on the results necessary for approval.

    Four factors will support the sufficient execution of this clinical trial. First, the CDC's awareness program has increased public knowledge of the disease. Second, the recent identification of a potential etiologic agent, namely a novel retrovirus, should help accelerate patient identification.

    Third, the company plans to utilize longstanding relationships with a group of internationally renowned clinical investigators to accelerate patient enrollment.

    Lastly, the company plans to expand recently entered contractual relationships with two of the largest clinical research organizations in the world to accelerate its clinical monitoring and data collection capacity.

    Finally, the company has adequate finances and resources to address and respond to all of these FDA recommendations. We have been and will continue to be committed to those suffering from Chronic Fatigue Syndrome. Additional information can be found at (12/17/09)[/QUOTE]
  5. fresh_eyes

    fresh_eyes happy to be here

    mountains of north carolina
    Very interesting Cort, thanks for posting.
  6. leelaplay

    leelaplay member

    Press Release - Hemispherx Biopharma Addresses Ampligen(R) Manufacturing Issues

    This was submitted by kelly to co-cure today, dec 23 09

    I particularly like Kelly's comments regarding the use of the word enigmatic, and the list of other known organic diseases for which there is yet no biomarkers and/or objective tests.


See more popular forum discussions.

Share This Page