An open label Phase III “intervention” study of the antiviral drug Ampligen® 511 - the most recent step in Hemispherx Biopharma’s decade-long quest for FDA approval of the drug as a CFS therapy - is recruiting subjects with “severely debilitating” CFS/ME at centers in seven states, nationwide, according to ClinicalTrials.gov.
Locations and Principal Investigators
The “chairs” or principal investigators of the trial, titled “An Open Label Study of Ampligen® in Chronic Fatigue Syndrome,” include three of the leading American names in CFS treatment:
n Daniel Peterson, MD, Sierra Internal Medicine, Incline Village, NV
n Lucinda Bateman, MD, Fatigue Consultation Clinic, Salt Lake City, UT
n Charles W. Lapp, MD, Hunter-Hopkins Center, Charlotte, NC
The other four listed trial locations include Los Altos, CA; Springfield, NJ; Philadelphia, PA; and Reston, VA.
Trial Design and Purpose
Hemispherx noted recently that a previous, not-yet-published Phase III (large) randomized placebo-controlled Ampligen® trial enabled the group of CFS patients who received the drug for twice weekly for 40 weeks to increase their exercise tolerance by an average of 15 percent compared with another group of CFS patients who were randomly selected to receive the placebo (fake dose).
The current trial, officially titled An Open Label Study of Ampligen® in Chronic Fatigue Syndrome (ClinicalTrials.gov Identifier: NCT00215813) will be:
n An expanded access (large-population) interventional trial to study and analyze in more detail the drug’s safety and effectiveness in affecting CFS symptoms among a large group of patients with “severely debilitating CFS/ME.”
n Open label, non-randomized, and uncontrolled. All patients will knowingly be receiving the drug Ampligen® (Poly I: Poly C12U). None will receive placebo.
n And importantly, the FDA has “approved the study for cost recovery.” This means patients enrolled in the study will be responsible for paying costs relating to the therapy – including the cost of the drug itself, and the cost of infusions, supplies, and diagnostic and other lab testing.
Though the trial-related costs are not specified, the drug is likely to be quite expensive if and when the FDA’s follow-up research supports approval of Ampligen® as a CFS therapeutic. Some project that the drug would cost $15,000 to $20,000 per patient per year, according to a recent article in Science News. (The co-inventor of Ampligen®, William A. Carter, MD, pioneered the clinical development of the antiviral therapy interferon, which now pulls down annual sales of $2 billion-plus.)
Eligibility and Inclusion Criteria:
Diagnosis of Myalgic Encephalomyelitis (ME) as defined by the 1988 Centers for Disease Control and Prevention (CDC) case definition for Chronic Fatigue Syndrome (CFS); ongoing for at least 12 months. (Other clinical conditions which could present with similar symptoms must be excluded.)
Ages 18 through 65.
Males or non-pregnant, non-lactating females
Females must be of non-child bearing potential (either post-menopausal for two years or surgically sterile including tubal ligation), or using an effective means of contraception (birth control pills, intrauterine device, diaphragm).
Females who are less than two (2) years post-menopausal, those with tubal ligations, and those using contraception must have a negative serum pregnancy test within the four (4) weeks prior to the first study medication infusion.
Females of child bearing potential agree to use an effective means of contraception from four (4) weeks prior to the baseline pregnancy test until four (4) weeks after the last study medication infusion.
A reduced quality of life as determined by a Karnofsky performance score (KPS) of from 20 to 60 at baseline. The KPS must be rounded in increments of ten (10).
Ability to provide written informed consent indicating awareness of the investigational nature of this study.
Documentation (during baseline or historically following onset of CFS/ME) of:
n A negative antinuclear antibody test (ANA) or a negative anti-ds (double-stranded) DNA,
n A negative rheumatoid factor,
n And an erythrocyte sedimentation rate (ESR).
Documentation during baseline of a normal T4 (or other laboratory evidence that the subject is euthyroid [normal thyroid]) is also required.
Please refer to this study by ClinicalTrials.gov identifier NCT00215813
Sharon Conway 215-988-0080 firstname.lastname@example.org
Please contact Hemispherx Biopharma for additional information regarding trial locations and site contacts:
By Fax: 215/988-1739
Mail: Hemispherx Biopharma, Inc. One Penn Center
1617 JFK Blvd., 6th Floor
Philadelphia, PA 19103
Study ID Numbers: AMP 511 Last Updated: October 24, 2006
Health Authority: United States: Food and Drug Administration ClinicalTrials.gov processed this record on 2006-10-27