hope for us CFS!! ON news today 3 phase clinical trial amlige

Discussion in 'Fibromyalgia Main Forum' started by Rene, Dec 27, 2002.

  1. Rene

    Rene New Member

    I got a call and my mom told me to turn on the news. A lady who is on the ampligen is 80% better!!!!!!! Its in the phase 3 clinical trial!! I'm really happy. It is taken by iv twice a week for up to 14 months. They didn't say how long it will take to get on the market but atleast it isn't phase 1 clinical trial!
    Rene
  2. Mikie

    Mikie Moderator

    This is encouraging even though it's just one person. If this is in the Stage III trials, there must have been enough positive results that others have benefitted as well. Thanks for sharing.

    I have both CFS and FMS and of the two, for me, the CFS is by far the most debilitating.

    Love, Mikie
  3. lilladybug

    lilladybug New Member

    Hemispherx Biopharma Completes Full Enrollment of its Phase III
    Clinical Trial for Chronic Fatigue Syndrome (CFS)


    Press Release
    Monday December 9, 9:27 am ET


    First Ever Completely Enrolled Phase III Clinical Trial for
    Disorder Affecting Over 500,000 Americans Surpasses Enrollment
    ----------------------------------------------------------------------------------------
    Target; Data Analysis Expected in 2003



    PHILADELPHIA--(BUSINESS WIRE)--Dec. 9, 2002-- Hemispherx
    Biopharma, Inc. (AMEX: HEB - News), a leading company in the
    experimental stage development of immune based therapies
    primarily addressing the diseases of HIV/AIDS and Chronic
    Fatigue Syndrome, announced today that its Phase III, pivotal
    study in Chronic Fatigue Syndrome (CFS) is now fully enrolled.

    CFS represents one of the last major chronic diseases, which has
    repeatedly defied pharmaceutical efforts to design a safe and
    effective therapy. According to the Centers for Disease Control
    (CDC), more than 500,000 Americans are afflicted with this
    severely debilitating condition which can ultimately lead to a
    bed-ridden state, dementia and, subsequently, a high incidence
    of cancer.


    First Ever Clinical Development Milestone in CFS Therapy


    The phase III pivotal study is rigorous in design and includes
    multi-center, randomized, double-blind and placebo-controlled
    components. As a fully enrolled program, it is the first Phase
    III clinical study ever successfully implemented in CFS, either
    in North America or Europe. The experimental immunotherapeutic,
    Ampligen®, is being given to more than 230 severely
    debilitating patients who have enrolled in the experimental
    program at multiple sites across the U.S. (described more fully
    at www.hemispherx.net). All 230 patients must meet rigorous
    medical and laboratory criteria in order to qualify.


    Historically, four (4) other multinational pharma companies, and
    two internationally recognized research institutes, including
    the National Institutes of Health (NIH), ceased product
    development at an earlier or Phase II level, because their
    experimental drugs were not shown to be statistically different
    from placebo in terms of improving physical performance or
    quality of life.


    Hemispherx is also the first biopharmaceutical company to
    receive treatment IND status for its experimental CFS treatment.
    Within the framework of this regulatory authorization, the
    Company is permitted to sell Ampligen® on a cost recovery basis
    in various parts of the world to severely incapacitated patients
    without any other therapeutic options available to them. This
    program is expected to expand in year 2003 now that the pivotal
    Phase III trial is fully enrolled.


    Year 2003 CFS Clinical Events Timetable


    By establishing full enrollment in the Phase III study, the
    company plans to conduct a statistically-based data analysis of
    the double-blind, placebo-controlled portion of the study during
    year 2003. In addition, new data from an ongoing open-label,
    Phase II study - conducted in parallel with the Phase III study
    at similar medical centers and utilizing demographically matched
    CFS patients - will be presented at the January, 2003,
    International CFS Conference in Chantilly, Virginia. This
    conference brings together world-renowned researchers on various
    aspects of CFS diagnosis and potential treatments.


    Research Platform In CFS


    For more than ten (10) years, Hemispherx has supported continued
    study of CFS via clinical and basic research grants to a
    community of internationally recognized researchers in CFS. This
    platform positioned the Company to design and execute the Phase
    III trial, now ongoing with its emphasis on both clinical and
    molecular insights into CFS therapy.


    About Hemispherx


    Hemispherx Biopharma, based in Philadelphia, is a
    bio-pharmaceutical company engaged in the manufacture and global
    clinical development of new drug entities in the nucleic acid
    (NA) class for chronic viral diseases and disorders of the
    immune system including, HIV, CFS and Hepatitis. Its platform
    technology includes large and small agent components for
    potential treatment of various chronic viral infections. For
    more information, including the full text of the abstract
    described in this press release, please visit the company's Web
    site at www hemispherx net


    Information contained in this news release other than historical
    information, should be considered forward-looking and is subject
    to various risk factors and uncertainties. For instance, the
    strategies and operations of Hemispherx involve risks of
    competition, changing market conditions, changes in laws and
    regulations affecting these industries and numerous other
    factors discussed in this release and in the Company's filings
    with the Securities and Exchange Commission. Accordingly, actual
    results including financial results may differ materially from
    those in any forward-looking statements. Additionally, all the
    referenced investigational drugs and associated technologies of
    the company are experimental in nature and as such are not
    designated safe and effective by a regulatory authority for
    general use and are legally available only through clinical
    trials with the referenced disorders. The forward-looking
    statements represent the Company's judgment as of the date of
    this release. The Company disclaims, however, any intent or
    obligation to update these forward-looking statements.



  4. Rene

    Rene New Member

    this is very good news. When I see the lady on tv who says she is 80% better that is great. I typen in ampligen on the world wide web and found good stuff. They have tested 400 people and the phase 3 trial started in 1999! A lady who has a journal on the internet who is in the trial got 70% better after only 24 WEEKS on it and she is back to being a professor. Wish I could give you her link but guess we cant. They already are using this in Canada and having good results.
    Rene
  5. gala

    gala New Member

    Sing me up. I know this is exciting news but for us CFS patients how long would it take before we actually can get the drug and/or can the average patient afford it. I want to get well so bad that I'll jump at anything and then get disappointed in the end. But, this does sound good.......Gala
  6. Mikie

    Mikie Moderator

    My local NBC affiliate just ran this story. I am hoping that this study continues to be encouraging and that this treatment will be available to those who can benefit from it. My guess is that if it has to be administered by IV for 14 months, the insurance companies will fight it tooth and nail.

    Love, Mikie