Hemispherx Biophrama, Inc.’s (AMEX Symbol: HEB) (Price: $8.875) presented 7 year old Ampligen data at the American Association for Chronic Fatigue Syndrome’s (“AACFS”) Fourth International CFS conference held in Boston this weekend. The conference Chairman confirmed that Hemispherx’s presentation of 7 year-old data was irregular. The data is based on flawed studies that have been available to researchers for years. No new data was presented. Hemispherx’s presentation was only one of the 32-CFS studies presented at the conference. We found no interest from the conference leaders we interviewed in the Ampligen data. The information available at the conference clearly showed that Hemispherx’s CFS treatment efficacy and sales potential claims are grossly exaggerated.
Hemispherx also conducted a videotaped Ampligen-patient presentation. This event was staged in a small room after the full day’s formal presentations were concluded. The patients were made available to clinicians and researchers for questions. However, the vast majority of those in attendance were CFS patients, not doctors or researchers. We found at least 5 stock promoters but none of the conference leaders in attendance. Two of the three patients were from the infamous Incline Village. All patients were part of Hemispherx’s cost-recovery program, which the company calls trials. In fact, these cost recovery treatments are not part of the FDA required 40 week Phase III trial. Hemispherx failed to disclose the number of sites and patients enrolled in the Phase III trial or if any Phase III participants have received Ampligen.
We found the Hemispherx patient event to have the appearance of a modern-day version of a 1900’s traveling medicine man show. The show included a promotional mention of Hemispherx’s stock and a lengthy statement by a patient with no known FDA legal experience claiming that Ampligen qualifies for FDA fast track approval. In fact, Hemispherx has not filed an NDA and none of the Ampligen’s CFS trials conducted over the last 8 years have been used in an NDA. We believe that Ampligen’s dated technology, dangerous safety profile and long history of trial failure make further human experimentation with this over 25 year-old drug unnecessary.
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