Ampligen is Designated First Specific Drug for CFS

Discussion in 'Fibromyalgia Main Forum' started by bioman85, Jul 6, 2006.

  1. bioman85

    bioman85 New Member

    PHILADELPHIA--(BUSINESS WIRE)--July 6, 2006--Hemispherx Biopharma, Inc. (AMEX: HEB) and the pioneering work it continues to do in the area of Chronic Fatigue Syndrome is receiving more recognition, this time in the cover story, Shadowy Syndrome: A Glimpse of Chronic Fatigue, in the latest issue of Science News (July 1, 2006; Vol. 170, No. 1). The exhaustive story, headlined , A Vexing Enigma: New Insights Confront Chronic Fatigue Syndrome, chronicles the challenges facing sufferers of Chronic Fatigue Syndrome (CFS) and highlights Ampligen(R), the experimental therapeutic from Hemispherx Biopharma as the only drug potentially nearing the market.

    The article highlights the research conducted by Dr. Lucinda Bateman, head of the Fatigue Consultation Clinic in Salt Lake City, and ongoing clinical research sponsored by the Centers for Disease Control and Prevention (CDC).

    The CDC has itself further validated research in this area when it recently sponsored 14 reports that gained a wider audience in a recent issue of Pharmacogenomics. While CFS was previously derided in some circles, the CDC's Suzanne D. Vernon officially concluded that the new research provides "evidence that chronic fatigue syndrome is a biologically distinct disease". One research group found that it could, with 76% accuracy, distinguish healthy volunteers from those with Chronic Fatigue Syndrome by analyzing 28 genetic polymorphisms. Even newer CDC data due to be published this fall estimates that CFS affects more than 1 million people in the United States.

    Dr. Bateman, who was recently appointed to the U.S. Government's Advisory Committee on CFS, acknowledges that among government-recognized medicines, "there are no direct treatment options, only supportive treatment options." According to earlier CDC studies, the primary symptom, profound post-exertion fatigue, dramatically affects quality of life and costs the U.S. economy billions of dollars each year.

    Scientifically valid evidence of even more serious concerns regarding CFS are now being discussed. In the first such ruling of its kind in the U.K., a coroner in England recently ruled that a 32-year old woman had died of complications caused by Chronic Fatigue Syndrome. For the record, CFS has repeatedly been cited as the cause of death in both the U.S. and Australia, according to the British magazine New Scientist.

    Hemispherx Biopharma's Ampligen(R), generically known as poly I:poly C12U, has completed Phase III studies on Chronic Fatigue Syndrome and data will be submitted to the FDA for New Drug Approval at the end of this year as a candidate for a direct treatment option.

    In the controlled Hemispherx Biopharma trial, Dr. Bateman and a team of co-investigators infused patients twice a week for 40 weeks while other volunteers received a placebo. Patients receiving the active drug who completed 40 weeks of treatment were able to exercise more aggressively than the other patients. On a standardized treadmill test conducted by an independent exercise physiologist, their exercise tolerance increased by more than 15% compared with that of the placebo group. This is an improvement associated with other quality-of-life changes as well.

    Published since 1922, Science News is an award-winning weekly newsmagazine covering the most important research in all fields of science.
  2. bioman85

    bioman85 New Member

    New Drug Application (NDA). Following the completion of all three phases of clinical trials, the company analyzes all of the data and files an NDA with FDA if the data successfully demonstrate safety and effectiveness. The NDA must contain all of the scientific information that the company has gathered. NDAs typically run 100,000 pages or more. By law, FDA is allowed six months to review an NDA. In almost all cases, the period between the first submission of an NDA and final FDA approval exceeds that limit; the average NDA review time for new molecular entities approved in 1992 was 29.9 months.
  3. yourtroubl

    yourtroubl New Member

    I mean I have never heard of that.
  4. cherylsue

    cherylsue Member

    according to my CFS doctor. It should be on the market in 3-5 years if gets FDA approval. That's what Oprahs's magazine article was referring to when it mentioned treatment.

    CherylSue
  5. cherylsue

    cherylsue Member

  6. deliarose

    deliarose New Member

    glad to see u posting again. I was wondering how the Xyrem is working out for u?
    Delia