Ampligen and its clinical trials found flawed and useless, reports Asensio & Company, Inc.

In its most recent annual report Hemispherx Biopharma Inc. (AMEX: HEB) (Price: $4.35) claims that HEB is developing a European organization and infrastructure to have a basic marketing and distribution system in place pending approval from the European Medical Evaluation Authority (“EMEA”). In fact, HEB failed to disclose that it was denied marketing authorization on September 4, 1999. A harshly worded negative 38-page assessment report by the Ministry of Social Affairs, Health and Environment accompanied the denial. A synopsis of the EMEA report’s executive summary will be available at

The report states that HEB’s application “revealed severe shortcomings and deviations from existing rules and guidelines, current scientific knowledge, progress in instrumentation and manufacture.” It calls HEB’s methods “rough estimations”, “not sufficiently characterized”, and “non-calibrated and outdated”. The report states that HEB has not even proved Ampligen’s “chemical identity and purity”. The report concluded that the application offered “no real pharmaceutical development”.

The report also states that the data HEB used as a basis for its medical claims “cannot be considered as a relevant and validated clinical end-point”. Even using HEB’s invalid data, Ampligen still failed. The report also states that “no information is available concerning the patient’s evolution–sustained effect–after stopping the treatment”, that the results “are not useful for efficacy assessment”, that open label trials “cannot be considered to assess the efficacy of Ampligen”, and that “the safety profile is poorly documented”. In concluding the report states that “general quality of this application is considered as very low” and that “marketing authorization cannot be granted”.

The EMEA assessment report provides yet more damning evidence that sheds further light on what we believe to be one of the darkest medical stock scams in modern U.S. capital market history. The organizers of HEB’s stock scam have already pled guilty to criminal charges. William A. Carter was HEB’s leader when HEB made payments and executed transactions that are the subject of at least 6 federal criminal indictments and other New York state indictments. Over the past 25 years, Carter has been accused of unethical and illegal behavior by HEB itself, of extortion by an AIDS patient, of scientific fraud by E.I. Dupont, of improper grant work by a hospital and his own staff, was fired by that hospital after years of disputes and lawsuits, is currently under investigation for fraud by the SEC and has been a subject of at least two congressional investigations of fraud. HEB is a rudimentary penny stock fraud that has attracted the interest of members of the U.S. Congress because of the involvement of leaders of the American Stock Exchange who have unscrupulously profited from their HEB trading, and the AMEX’s failure to act to protect the public.

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