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FDA declines to approve Hemispherx's Ampligen new drug application

Discussion in 'General ME/CFS News' started by Lynn, Feb 4, 2013.

  1. Sasha

    Sasha Fine, thank you

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    BTW, Bob has ended his hunger strike, is fine - I'm starting a new thread on that.

    Big relief to all of us, I suspect.
     
    dannybex, Kati, BEG and 1 other person like this.
  2. dannybex

    dannybex Senior Member

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    Kati and Barb: Well, I guess I understand, especially Kati, considering your mom's situation, and Barb, who comes from a nursing background (?). Very sorry about your mom Kati.

    At the same time you're both reading far too much into what I asked or said (coffee enemas?!). I'm not saying drugs are out of the question, or never necessary, but to ignore the methylation issues (found in almost every CFS patient so far), how carnitine helps with mitochondrial issues, omega 3's help with circulation and inflammation, etc. not to mention ignoring the obvious changes in what we eat compared to 50-60 years ago...well, I guess we'll have to agree to disagree, and wish each other well. :)

    And Sasha -- that's great to hear about Bob. I'm amazed he survived, and glad to hear he's eating again.
     
    Valentijn likes this.
  3. barbc56

    barbc56 Senior Member

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    I think there are many people on these threads who are doing this.;)
     
  4. Kati

    Kati Patient in training

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    I'm eating fish probably 3 times a week. Wild salmon, sometimes cod. And meat.

    Methylation problems have not been brought up to me by the experts I have seen. COQ 10 and carnitine have not been helpful to me and they are both expensive. i refuse to experiment and reading about people's experiments here, I do not feel any comfort in their safety. Moreover, I personally find that other patients and sometimes non-patients recommendations sounds more like medical advice and it can be unsafe. That's my opinion. So I do not visit these threads.

    It's just not my cup of tea.
     
    barbc56 likes this.
  5. Firestormm

    Firestormm Guest

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  6. Sparrowhawk

    Sparrowhawk Senior Member

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    I'm coming late to this discussion but I didn't see and answer to this question on page one:

    "Without approval could doctors still prescribe off-label? I'm assuming this is unlikely as the drug is so expensive (can't help thinking that's at the root of the refusal; neither insurers nor the vastly cut budget of Medicaid want to pay)."

    Is the Ampligen trial still going on in NC, self pay?
     
  7. JohnnyD

    JohnnyD Senior Member

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    Drugs must be approved in order to be prescribed off-label. Ampligen is experimental. Ampligen for CFS is available only through the AMP 511 Cost Recovery Trial. Presumably, if Ampligen were approved, the cost would come down due to economy of scale. Blue Cross Blue Shield has had Ampligen listed, for some time, as a drug they would cover/pay for (permission needed in advance) when approved.

    I don't know for sure -- but I think Dr. Peterson is currently the only doc administering Ampligen. The reason I say this is that he had a recent interview (see ME/CFS Alert) where he stated he currently had 28 patients on Ampligen. Hemispherx 10-Q, released last Friday listed 28 patients currently on Ampligen.
     
    Sparrowhawk likes this.
  8. Nielk

    Nielk

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    I think there are a few doctors providing Ampligen. Dr. Enlander is one in New York.
     
    vli likes this.
  9. vli

    vli

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    Nielk, my thoughts exactly!!! I don't believe Mary Schweitzer has stopped getting ampligen from him??!
     
    Nielk likes this.
  10. JohnnyD

    JohnnyD Senior Member

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    Here are the 5 authorized 511 centers. They are all listed as recruiting patients (in clinicaltrials.gov), but I suppose the only way to know for sure, what kind of patient load they have and if they are indeed recruiting, is to call or email them.

    Locations
    United States, Florida
    Nova Southeastern University Chronic Fatigue Center Recruiting
    Miami, Florida, United States, 33176
    Contact: Ernesto Martinez Duarte 305-595-4300 emartinezduarte@nova.edu
    Principal Investigator: Nancy Klimas, MD
    United States, Nevada
    Dr. Daniel Peterson Recruiting
    Incline Village, Nevada, United States, 89451
    Contact: Kathleen Colley 775-832-0989 kathleen@ishere.com
    Principal Investigator: Daniel Peterson, MD
    United States, New York
    Dr. Derek Enlander Recruiting
    New York, New York, United States, 10065
    Contact: Laura Melilli 212-794-2000 enlandercfs@yahoo.com
    Principal Investigator: Derek Enlander, MD
    United States, North Carolina
    Hunter-Hopkins Center, PA Recruiting
    Charlotte, North Carolina, United States, 28210
    Contact: Wendy Springs 704-543-9692 wendy@drlapp.net
    Principal Investigator: Charles Lapp, MD
    United States, Utah
    The Fatigue Consultation Clinic Recruiting
    Salt Lake City, Utah, United States, 84102
    Contact: Ali Allen ali@fcclinic.com
    Principal Investigator: Lucinda Bateman, MD
     
    vli likes this.
  11. vli

    vli

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    I'm sure the above list is accurate.
     
  12. Bob

    Bob

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    Here's some limited information about a phase III trial of Ampligen for CFS in a press release from Hemispherx:
    http://online.wsj.com/article/PR-CO-20140319-906721.html


    Perhaps it relates to this:
    Study of Ampligen in Chronic Fatigue Syndrome
    http://clinicaltrials.gov/show/NCT00215813
    http://forums.phoenixrising.me/inde...f-ampligen-in-chronic-fatigue-syndrome.23007/
     
    Last edited: Mar 24, 2014
    SOC and Sparrowhawk like this.
  13. JohnnyD

    JohnnyD Senior Member

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    There is a followup PR released today. I think what Hemispherx is trying to do here, is present/promote a new endpoint. that is, if a new study is required.


    PHILADELPHIA, March 24, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) participated in the 11th Biennial International Research and Clinical Conference held in San Francisco, California, USA, on March 20-23, 2014. The title of the presentation was "Differential Exercise Responses to Rintatolimod [Ampligen(R)] Exhibited by Patients with Severe Chronic Fatigue Syndrome (CFS)". This Phase III prospective, double-blind, randomized, placebo-controlled trial was conducted at twelve centers by leading researchers in fatigue and post-exertional fatigue.

    The data on the experimental immunotherapeutic included a re-examination post-hoc of the primary and secondary endpoints as a function of dichotomization of patient responses.

    Dichotomization of improvement in exercise performance from baseline at the >=25% and >=50% levels were analyzed on the Intent-to-Treat (ITT) Population. For the ITT population a significantly greater percentage of rintatolimod patients (39%) vs. placebo patients (23%) improved ET (exercise tolerance) duration by >=25% (p=0.013) while 26% compared to 14% of rintatolimod vs. placebo patients, respectively, improved ET duration by >=50% (p=0.028). A frequency distribution analysis of >=25% improvement, =25% worsening in ET from baseline at 40 weeks for the baseline >9 minutes cohort showed net improvement to be 18.3% for the rintatolimod cohort vs. 4.6% deterioration for placebo (p=0.015). A continuous responder analysis using 5% increments from >=25% to >=50% provided a robust clinical enhancement in ET effect in the rintatolimod cohort for the ITT population, as well as, for a subset of patients with baseline ET duration >9 minutes as compared to placebo. The Karnofsky Performance Score (KPS) and Vitality (SF-36 subscale) quality of life secondary endpoints demonstrated similar clinically significant improvements for the rintatolimod cohort as a function of the same ET dichotomization. Rintatolimod was generally well-tolerated in this CFS/ME population.

    http://finance.yahoo.com/news/hemispherx-biopharma-inc-presented-clinical-123000373.html
     
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