Hemispherx Biopharma, Inc. (AMEX: HEB) (Price: $7.6875)disclosed in its Form 10-K for the year ended December 31, 1999 filed on March 29, 2000 that its Ampligen HIV emergency treatment protocol was withdrawn and that its Ampligen HIV Phase II trial protocol was deemed deficient by the FDA. Hemispherx had recently announced the FDA HIV filings in several press releases. Hemispherx has not announced the withdrawal or the rejection.
In its September 30, 1999 Form, Hemispherx disclosed that enrollment in its Phase III study of Ampligen as a treatment for Myalgic Encepahlomyelitis/Chronic Fatigue Syndrome (“CFS”) had reached “75% of the targeted 230 patients have been recruited.” Hemispherx’s 1999 Form10-K states that “it has recruited and enrolled more than 60 per cent of the required 230 patients.” These disclosures show that Hemispherx has been unable to attain full enrollment and has actually reported a decrease in the number of patients recruited versus recruited and enrolled. Hemispherx claims to have started enrolling patients for CFS Phase III test in August 1998. Hemispherx has had approval to conduct a CFS trial for 7 years.
Also in its Form 10-K, Hemispherx disclosed that “in April, 1999, the Company was advised by the Securities and Exchange Commission (“SEC”) of a private investigation into various allegations of misrepresentations by the Company and its officers. Specifically, the SEC sought information relating to allegations about the Company’s investigational drug application for treatment of various diseases, results of clinical research, incidence of ME/CFS in the United States, the Company’s patents, and Ampligen’s safety and efficacy.” Hemispherx has claimed that investors who have sold its shares short were under investigation. The making of this false and perverse claim is common among managers of fraudulent stock promotions like Hemispherx.
Asensio & Company, Inc. is a New York-based investment bank. In October 1998, Hemispherx commenced a civil action against Asensio & Company, Inc. and its Chairman, President and Chief Executive Officer Manuel P. Asensio, alleging, among other things, securities violations, fraud and RICO. All of Hemispherx’s RICO, securities violations and fraud claims have been dismissed with prejudice. Yet Hemispherx continues to falsely claim its suit is related to its baseless claims against short sellers that it uses as part of its fraudulent stock promotion scheme. Hemispherx has failed to show a single Asensio statement that was or is misleading or incorrect. Asensio & Company, Inc. has counter-claimed, and continues to investigate and issue accurate and complete research reports and short sell recommendations on Hemispherx’s stock.
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