Philadelphia, PA, Tuesday, December 12, 2006: Hemispherx, Inc. (Amex: HEB), a biopharmaceutical firm focused on RNA-based therapeutic solutions for chronic severely debilitating diseases, has today commented on the growing visibility of Chronic Fatigue Syndrome (“CFS”) as a serious disease.
In May 2006, Dr. Julie Gerberding of the Centers for Disease Control (“CDC”) referred to CFS as a “…disabling disease, as disabling as other severe chronic conditions like multiple sclerosis, COPD and rheumatoid arthritis.” This was in response to findings by a research team led by the CDC’s Drs. William Reeves and Suzanne Vernon, which published ground-breaking research that suggests a biological basis for CFS.
In recent weeks, the CDC has stepped up its public awareness campaign, broadcasting public service announcements on radio and television, as well raising the spotlight on its website, www.cdc.gov. The Agency’s new public service announcement states that CFS affects more than 1 million Americans annually.
Commenting on the elevated visibility for the CDC’s public awareness campaign, Hemispherx’s Chief Executive Officer, Dr. William Carter, noted, “The CDC has raised the spotlight on a crippling human disease for which there has heretofore been little recognition or diagnosis, much less a curative therapy or relief. But in fact, Chronic Fatigue Syndrome affects more than four million people every year, and costs the U.S. economy many billions of dollars per year. So the scrutiny and attention now being brought by the CDC is not only deserved, it is welcome.”
Treating CFS has proven elusive for the healthcare industry. While several of the multinational pharmaceutical companies have tackled the symptoms and causes of CFS, none to date have had measurable success in developing new drugs. Currently, there are no approved therapies for CFS. Hemixpherx hopes to change that next year with its commercial application for Ampligen®, an experimental therapeutic, for which the Company has completed clinical trials.
Ampligen®, an experimental drug, is a double-stranded (ds) RNA with a well-established, clinical profile. It has been studied extensively in the treatment of Chronic Fatigue Syndrome (CFS). TL3 receptors are known to recognize viral double-stranded (ds) RNA, a molecular pattern associated with increasing host defenses against disease. Ampligen activates the TLR3 receptors on respiratory epithelium. Patients with CFS have severe ambulatory problems related to diminished uptake of oxygen similar to patients with severe angina or chronic respiratory disease.
A new drug application, or NDA, is in preparatory stages, and Hemispherx management has targeted the fourth quarter of 2006 for its filing with the U.S. Food and Drug Administration.
Based on Phase 2 clinical data, the Agency for Healthcare Research and Quality, a division of the U.S. Department of Health and Human Services, reported that Ampligen® yielded “the most promising results” of the new experimental therapies under review. Since then, Phase 3 clinical trials have been completed and will be summarized at the upcoming 8th International IACFS Conference on Chronic Fatigue Syndrome in January 2007.
A total of five open-label and three double-blind, placebo-controlled trials have been completed, with a total of 757 subjects. Safety profiles from the administration of more than 75,000 intravenous doses (most commonly 400 mg), twice weekly, for one-year periods or greater compared favorably to patients receiving only placebos, or otherwise matched control groups. Animal toxicity studies support this observation in humans. Clinical trials with primates demonstrated an even more favorable margin of safety than earlier results from studies in lower animals.
Primary endpoints were achieved with statistical significance in all Ampligen® clinical trials. In the completed Phase 3 trial, patients receiving Ampligen® for 40 weeks improved exercise treadmill performance 14.8% in the placebo group (p=0.025) and 13% by intent to treat analysis (p=0.052).
The Ampligen group improved oxygen utilization by 6.1% v 0.58% in the placebo group (p<0.05, single-sided). The correlation with treadmill exercise duration in patients treated with Ampligen® was highly significant (p<0.0001). The KPS (Karnofsky performance score), a function of general physical capacity, was also significantly correlated (<0.01) with the improvement in exercise tolerance of the Ampligen® study arm.
Patients with CFS use large quantities of pain, sleep, and CNS anti-depression drugs to alleviate the symptoms associated with CFS. The concomitant use of drugs with Ampligen® or placebo was reduced significantly in the Ampligen® arm of both the Phase 2 and Phase 3 trials. Only regulatory agencies can opine whether any experimental drug is “safe and effective”. These data are presented solely for comparative historical purposes.
Dr. William A. Carter, Chairman and CEO of Hemispherx Biopharama, Inc. observed, “This disorder has been recently linked with dysregulation of gene expression associated with energy metabolism. The improvement in exercise duration is highly correlated to improvement in oxygen utilization and physical performance. A possible mechanism of therapeutic action(s) may include improvement in the genetic control of energy metabolism.”
Dr. Carter stated, “We are committed to developing treatment options for the millions of patients now being diagnosed with Chronic Fatigue Syndrome, both in the United States and elsewhere in the world. The Centers for Disease Control are to be commended for elevating the level of visibility for this disease.”
People desiring more information about Chronic Fatigue Syndrome should visit the Centers for Disease Control website and its section on CFS:
Those wishing to review the Public Service Announcements produced by the CDC for radio and television broadcasts, as well as a personal message from the Director of the CDC, Dr. Julie Gerberding, should visit:
Additional information about Hemispherx Biopharma’s work in CFS, as well as other product development efforts addressing RNA-based therapeutic solutions for chronic diseases and immune system disorders, may visit the Company’s website:
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics Ampligen® and Oragens®. Alferon N Injection® is approved for a category of STD infection, and Ampligen® and Oragens® represent experimental RNA nucleic acids being developed for globally important chronic debilitating diseases. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 100 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N Injection®) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net