On February 7, 2001, Hemispherx Biopharma, Inc. (AMEX Symbol: HEB; $4.92) announced it had presented preliminary findings for the treatment of Chronic Fatigue Syndrome (“CFS”) with Ampligen under an expanded access program. The Hemispherx release states that Ampligen was generally well tolerated in the alleged study. In fact, the U.S. Food and Drug Administration (“FDA”) has issued three letters to Hemispherx regarding violation of FDA laws for false and misleading statements made in Hemispherx’s press releases and Internet site regarding the alleged safety and efficacy of its alleged drug Ampligen.
Hemispherx did not refer to its current CFS Phase III trials. Hemispherx has had approval to conduct a CFS trial for over 7 years and has never completed the Phase III CFS trial. In fact, Hemispherx never completed any Phase III trial in the 20 years it has been claiming that Ampligen is effective in treating at least six diseases.
Hemispherx claimed to have presented the findings at the American Association for Chronic Fatigue Syndrome (“AACFS”). We reviewed the conference agenda and list of invited speakers provided by the AACFS. Hemispherx is not listed as a presenter at the conference and Ampligen is not the topic of any presentations.
Asensio’s due diligence has uncovered evidence of Hemispherx and its CEO, William A. Carter’s involvement with irregular medical research and publication of untrue medical claims. Hemispherx is currently the subject of a securities fraud investigation by John D. Dingell, Ranking Member of the Committee on Commerce of the U.S. House of Representatives. In furtherance of Representative Dingell’s investigation, the U.S. General Accounting Office is conducting a review of Hemispherx regarding fraud in Hemispherx’s AMEX stock trading. In 1989 Carter was the subject of an investigation into scientific fraud by the House Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce. At the time, Representative Dingell was the Chairman of that Subcommittee. Carter and Hemispherx are currently being investigated for fraud by the U. S. Securities and Exchange Commission (“SEC”), and have been accused of fraud by an AIDS patient and of making material untrue and misleading statements by the chemical firm E.I. Du Pont de Nemours and Company (“Du Pont”). Many of Hemispherx’s officers and promoters are known career stock promoters. In addition, Hemispherx insiders and a former Hemispherx officer have been criminally indicted on charges including fraudulently manipulating Hemispherx’s stock.
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