Hemispherx Biopharma, Inc. (AMEX symbol: HEB) (Price: $7.25) has issued press releases and an investor publication titled “General Information on Chronic Fatigue Syndrome” that report false and exaggerated, national U.S. prevalence rates for Chronic Fatigue Syndrome (“CFS”). In its investor publication Hemispherx claims that studies from Harvard University and the Centers for Disease Control and Prevention (“CDC”) support the belief that 1,000 of 100,000 Americans or 2.5 million people in the United States suffer from CFS. This statement is completely false. No such studies exist. None of the studies cited are related to Harvard. None are national, and none support Hemispherx’s claimed CFS prevalence rate.
Hemispherx has used false and misleading statements about Ampligen’s safety, trials, patents and FDA status along with false CFS prevalence rate information in its stock promotion. Hemispherx’s claim that Ampligen has no side effects contradicts Ampligen’s only published safety profile, which is included in Hemispherx’s public filings. Hemispherx has misrepresented the results of Ampligen’s 8 year-old CFS Phase II trials by claiming the trials showed that Ampligen is an effective CFS treatment. Hemispherx has also misled investors about Ampligen’s patents. Ampligen is a 25 year-old off-patent drug. Its composition patent expired in May 1994. Hemispherx has no exclusive rights to manufacture Ampligen. Hemispherx has had FDA approval for over 6 years permitting Ampligen to conduct Phase III CFS trials. Despite this 6 year old approval, Hemispherx has failed to conclude Ampligen’s Phase III CFS trials.
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