Ampligen trial of CFS patients in Belgium shows significant improvements.

SAN FRANCISCO--(HealthWire)--Oct. 15, 1996--

No evidence of significant toxicities

Results of a Belgium clinical study presented today at the annual scientific meeting of the American Association for Chronic Fatigue Syndrome (AACFS) evidenced that the antiviral and immune modulatory drug Ampligen(R) produced significant physical and cognitive improvements among patients suffering from Chronic Fatigue Syndrome. The study was presented by Kenny De Meirleir, M.D., Ph.D. from the University of Brussels, and by David Strayer, M.D., Professor of Medicine at Allegheny University, PA, and Medical Director for HEMISPHERx.

The improvements observed in the two key measurements of physical performance used for the 24-week long Belgium study confirmed and extended earlier findings obtained from open-label and placebo-controlled American trials. The two measures of physical performance were Karnofsky Performance Score (KPS), used to measure activities of daily living; and exercise performance on a bicycle. KPS improved 43 percent from a severely debilitating level of 53 to a level of 76. A KPS score of 80 describes an individual who can perform normal activities with effort, but continues to have limited signs of the illness. On the bicycle testing, Belgium patients improved oxygen uptake significantly, from 1.16 liters/minute before the twice-weekly Ampligen administration of 200 to 400 mg, to 1.48 liters/minutes after treatment.

In addition to physical improvement, significant cognitive improvements were documented among patients on the three Ampligen trials, using the cognitive subscale of the SCL 90-R or neuropsychological function tests. The Ampligen treatments were generally well tolerated.

By contrast, spontaneous recovery of untreated patients suffering from CFIDS is low. Earlier studies indicate that only 2 percent of the CFIDS population report spontaneous improvement to normal function. In the randomized, placebo-controlled trial, the patients treated with Ampligen showed significantly greater improvement in both physical and cognitive function than the patients who received placebo. In the two open label studies, Ampligen therapy resulted in performance improvements greater than previously reported for placebo-effects in CFIDS in terms of magnitude and duration.

Strict Standards for Patients

Patients in the Belgium and American Ampligen trials met the strict definition of a disease subset as defined by the Centers for Disease Control and Prevention (CDC). Chronic Fatigue Syndrome, also known as Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), or Mylagic Encephalomyelitis (ME), is a multisystem syndrome characterized by months of debilitating fatigue frequently associated with myalgia, headache, sore throat, low grade fever and tender lymph nodes. The medical community estimates that approximately 400,000 people suffer from CFIDS in the United States. The illness interferes with every-day simple tasks such as walking, driving a car, and remembering appointments, and it causes some patients to become bedridden.

Ampligen, a drug manufactured by HEMISPHERx Biopharma, Inc. (NASDAQ: HEMX), Philadelphia, PA, is an antiviral and immune modulatory drug under the nucleic acid class of drugs (NAs). NAs are drugs designed to mimic the body's own digitized informational molecules (called DNA and RNA) which, in some laboratory and animal studies, reprogram certain diseased cells to enhance their intrinsic disease capabilities.

HEMISPHERx is a pharmaceutical company engaged in the manufacture and global clinical development of drug entities in the NA class for chronic viral diseases and disorders of the immune system. To date, HEMISPHERx and its subsidiaries have received over 200 patents internationally to protect its proprietary position in NA and related drug technologies.

CONTACT: HEMISPHERx Biopharma, Philadelphia

William A. Carter, CEO, 215/988-0080

or

VMW, New York

Vicki Miles Weiner, 212/605-3140

[e-mail]