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Strategies & Market Trends : CAVALRY'S SHORT BUSTERS - MAGIC EIGHTBALLS PICKS -- Ignore unavailable to you. Want to Upgrade?

To: Janice Shell who wrote (1050)	10/14/1998 9:20:00 PM
From: Cavalry	Read Replies (1) \| Respond to of 1637

magic eightball says meet the single press release that destroys the shorts who followed asenio to destruction, he has been exposed, poof Hemispherx Announces New Studies on Ampligen Safety NEW YORK, Oct. 14 /PRNewswire/ -- Hemispherx Biopharma (Amex: HEB) today announced the completion of four new animal studies on the safety of its developmental drug Ampligen, which will be submitted in support of its application for full marketing approval in the European Union for the treatment of Chronic Fatigue Syndrome (CFS). While U.S. FDA guidelines limit what comments a company can make regarding the safety of a developmental drug, the results of Hemispherx's extensive analysis of clinical data and related animal studies were submitted to the FDA prior to the FDA's authorization for Hemispherx to proceed with Phase III clinical trials. The four new studies were designed and conducted after strategic input by various FDA reviewers in order to support the Company's intended U.S. regulatory filing for a CFS marketing approval. The new studies were conducted by a major independent contractor and included long-term (6-month) tolerance studies in both the rat and the monkey, the latter primate generally judged to be very close to humans in response patterns. The results indicate that Ampligen has a favorable safety profile and is generally well tolerated in the primate species. No evidence of any cardiac toxicities were seen in the studies. Previous nationwide detailed cardiac studies (including echocardiograms and EKGs) on long-term Ampligen patients did not reveal any abnormalities attributable to the drug. These previous studies were interpreted by an independent, Board certified cardiologist and, thereafter, the results were submitted to the FDA prior to its authorization of Phase III trials. The original undertaking of the new studies whose results were announced today was a mandatory prerequisite to advance to Phase III cost recovery status with various regulatory bodies internationally. The Company thoroughly analyzes potential adverse side effects, which have occurred in approximately 15% of patients who have undergone Ampligen treatment. The experience of most of these 15% was an occasional mild flushing of the skin. Beyond this flushing, previously reported clinical data have indicated that the number of adverse events reported by patients receiving Ampligen was virtually identical to that reported by patients receiving placebo. While patients on both placebo and Ampligen reported a number of adverse events, no statistically significant differences between the groups were found except in the case of insomnia (which was higher among the placebo patients) and dry skin (which was higher among Ampligen patients). Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factor and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward-looking statements. SOURCE Hemispherx Biopharma, Inc. CO: Hemispherx Biopharma, Inc. ST: New York IN: MTC SU: 10/14/98 16:00 EDT prnewswire.com