Ampligen Safety Profile.

The following Ampligen Safety Profile has been copied directly from pages 43 and 44 of Hemispherx Biopharma, Inc.’s (“Hemispherx”) Initial Public Offering Prospectus dated November 2, 1995 (“Prospectus”). This description contains both Hemispherx’s characterization of the data and a data disclosure. Our analysis of Ampligen’s safety profile is based on the data not Hemispherx’s claims or interpretation.

The third paragraph below contains a disclosure about a 1992 Food and Drug Administration (“FDA”) approval for Phase III clinical trials of Ampligen for ME/CFS treatment. We believe that this reference by Hemispherx was included to create the impression that the FDA has found that Ampligen’s side effects are insignificant. Approval to conduct Phase III trials does not imply that the FDA believes the drug’s side effects listed in the profile are not serious. In any case, Hemispherx fails to disclose the full text of FDA’s statement. Furthermore, the Company has had approval for Phase III trials for over six years and has not filed results to any Phase III tests with the FDA. The Ampligen Safety Profile below is directly extracted from Hemispherx’s Prospectus:

The Company [Hemispherx] believes that Ampligen has been generally well tolerated in more than 15,000 patient treatment weeks with a low incidence of clinical toxicity, particularly given the life threatening diseases being treated. Clinical experience with Ampligen now totals 311 patients, of whom 171 patients have received Ampligen for six months or more. Of these patients, 117 patients have received Ampligen for one year or more; 63 patients have received Ampligen for two years or more; and 22 patients have received Ampligen for periods in excess of three years. A mild flushing reaction has been observed in approximately 15% of patients treated in the Company’s various studies. This reaction is occasionally accompanied by erythema, a tightness of the chest, tachycardia, anxiety, shortness of breath, subjective reports of “feeling hot,” sweating and nausea. The reaction is usually infusion-rate related and may generally be controlled by slowing the infusion rate. Other adverse side effects include liver enzyme level elevations, diarrhea, itching, urticaria (swelling of the skin), bronchospasm, transient hypotension, photophobia, rash, bradycardia, transient visual disturbances, arrhythmias, decreases in platelets and white blood cell counts, anemia, dizziness, confusion, elevation of kidney function tests, occasional temporary hair loss and various flu-like symptoms, including fever, chills, fatigue, muscular aches, joint pains, headaches, nausea and vomiting. These flu-like side effects typically subside within several months.

In February 1992, after the conclusion of the Phase II ME/CFS Study and subsequent to the Company’s submission of data from that study to the FDA, the FDA advised the Company, among other things, of certain concerns regarding the safety profile of Ampligen. Specifically, the FDA noted that various side effects of Ampligen had been observed during the Phase II ME/CFS Study, including severe liver toxicity, severe swelling and itching of extremities, severe chest pain, severe muscle cramps and severe flu-like symptoms. These observations were made by the FDA in the context of the FDA’s review of the Company’s proposed protocol for a Phase II/III ME/CFS trial.

In July 1992, the Company responded to these concerns by providing an analysis of the side effects data obtained from the Phase II study and the treating physicians’ views. The Company observed that many of the side effects described by the FDA were regarded by both the Company and the treating physicians of those patients as unrelated to Ampligen treatment. The Company advised the FDA of the Company’s view that the data from the Phase II ME/CFS Study indicated that Ampligen appeared to have a favorable risk/benefit ratio for ME/CFS. On October 9, 1992, the FDA authorized the Company’s proposed Phase II/III clinical trial for ME/CFS, concluding “that it is reasonably safe for the initiation of [the Company’s] proposed clinical study.” This regulatory action allows Ampligen to be administered for up to one year to an additional 115 patients (in a 230 patient placebo-controlled trial).

In February 1993, the FDA raised an issue regarding possible side effects of Ampligen which grew out of the agency’s review of an animal study conducted in 1987 involving beagle dogs. Although the results of this study suggest a possible association between Ampligen administration and focal epicarditis (a small localized area of inflammation of the outer lining of the heart), the study did not establish whether the epicarditis observed was attributable to Ampligen administration. The meaning of these findings in the beagle dog and how they relate to human clinical experience is not presently known. Because these conditions were not observed in any other animal studies or in the clinical trials conducted in humans over the previous ten years, the Company believes that these findings may be restricted to the beagle dog. The FDA has requested that the Company conduct an additional toxicity study of Ampligen in beagle dogs. The Company has agreed to this request, and expects to conduct this study during 1995 or 1996. The FDA has also asked the Company to revise the informed consent forms provided to patients upon enrollment in the Company’s clinical trials to include the findings of the 1987 study concerning epicarditis in beagle dogs, as well as other toxicities observed during the course of the Company’s various preclinical toxicology studies in rabbits, rats, dogs and monkeys. The Company has revised its informed consent forms in accordance with this request. Finally, the FDA has also asked the Company to conduct cardiovascular follow-up examinations on selected patients in accordance with criteria suggested by the FDA. The Company has complied with this request. These examinations, the results of which were submitted to the FDA in March, April and May, 1993, showed no evidence of Ampligen-induced epicarditis in these patients. The Company believes that it has adequately compiled with the FDA’s requests for information and believes that the issues raised by the FDA will not have a material effect on the Company’s efforts to receive approval for Ampligen as a treatment for ME/CFS, although no assurances can be given.

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