To: The Street who wrote (541 ) 11/2/1998 2:53:00 AM From: Cavalry Read Replies (1) | Respond to of 857
theres no joy in shortville today, instant ampligen, no more messy preparation even a short seller could figure out how to use this Hemispherx Develops 'Ready-to-Use' Ampligen(R) PR Newswire - November 02, 1998 02:45 Tedious Drug-Reconstitution Procedures are Now Replaced by Streamlined Approach NEW YORK, Nov. 2 /PRNewswire/ -- Hemispherx Biopharma, Inc. (Amex: HEB) announced today that it has begun treating Chronic Fatigue Syndrome (CFS) patients in clinical programs with a new "ready-to-use" liquid form of the investigational drug Ampligen(R). Hemispherx said that the ready-to-use liquid form of Ampligen(R) significantly improves Ampligen's potential commercial viability in terms of ease of use, pending the medical evaluation of the drug in Phase III clinical trials that are currently underway. Before the introduction of this ready-to-use liquid format, Ampligen(R) was supplied to clinical sites either in a frozen state or as a freeze-dried powder and stored in a special non-frost-free freezer. However, with this new format, Hemispherx can ship ready-to-use drug dosages to clinical locations around the U.S. from its manufacturing/quality-assurance facility in Rockville, Maryland. Extensive testing of the ready-to-use liquid form of Ampligen(R) has indicated that the product is stable and retains its full potency without the use of preservatives or special refrigeration. The results of the stability and all bio-equivalency tests on the ready-to-use liquid form of Ampligen(R) were submitted to the FDA for full review and comment prior to the use in clinical settings. Hemispherx said that it is switching patients who are now receiving Ampligen(R) therapy from the frozen product to the ready-to-use liquid format in the ongoing pivotal trial termed AMP 516. When applying the frozen format, nurses or physicians were required to thaw, heat and cool the product in a water bath just prior to administration, according to a detailed drug reconstitution protocol. In the freeze-dried format, hospital pharmacies were required to combine up to 8 small vials each consisting of 50 mg of the powder into a final dosage unit in a special sterilized environment including use of a laminar flow hood. These steps, however, are no longer required with the use of the ready-to-use liquid form of Ampligen(R). Thus, the availability of the ready-to-use format of Ampligen(R) offers conveniences related to storage and administration while reducing the chance of potential mistakes taking place during preparation in locations removed from the manufacturing facility itself. Hemispherx, based in Philadelphia, is a biopharmaceutical company. The Company is engaged in the manufacture and global clinical development of new drug entities in the nucleic acid (NA) class for chronic viral diseases and disorders of the immune system including CFS (Chronic Fatigue Syndrome). Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors 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. /CONTACT: William A. Carter, M.D., CEO and Chairman of Hemispherx Biopharma, 215-988-0080; or William J. Jenks, Media for Hemispherx, 212-232-2222, fax, 212-232-3232; or Sharon Will, Hemispherx Investor Relations, 212-572-0762, or fax 212-572-0764/