asenio will fire another shot any day
constant shareholder updates great weapon vs shorts 2:30 am release on time again, love that heb, no company can come up with daily releases forever, spoon feeding in pieces their findings is intelligent tact
10/19/98 - HEMISPHERX: NEW CLINICAL DATA IN ONGOING CFS TREATMENT PROGRAM
New Data Through mid-1998 Compared with Historic Baselines
NEW YORK, Oct. 19 /PRNewswire/ -- Hemispherx Biopharma (Amex:HEB ), today released additional data from its ongoing Phase II clinical trials with the drug Ampligen(R) in the treatment of Chronic Fatigue Syndrome (CFS), as presented in a paper this past week at the American Association for Chronic Fatigue Conference in Cambridge, MA.
As summarized in the table below, studies B and D represent clinical programs that are currently underway, generating continuous new data and enrolling new patients. The data from these studies as presented at the Cambridge conference were the latest analyzed data available, representing results through mid-1998. Study A (first reported in a peer reviewed journal in 1995) and study C (first reported in a peer journal in 1994) were included to provide a complete set of cumulative data for comparative baseline analysis. Overview of Four Phase II Clinical Trials of Ampligen Therapy in CFS Study A Study B Study C Study D Study Design open-label open-label randomized, open-label placebo-controlled cost -recovery # of Patients 15 45 92(19) 30 % Female 73% 70% 75%(74%) 70% Age (mean) 44 35 35(40) 41 Duration (weeks) 24+ 24+ 24+ 24+ Dose (mg) 200-400 200-400 200-400 200-400 Dosing Frequency Twice weekly Twice weekly Twice weekly Twice weekly (thrice weekly) Location USA Belgium USA USA In addition to providing baselines, comparative analysis helps determine whether the natural history of the untreated disease is constant or variable over time and whether response to the drug (including outcome parameters and adverse event parameters) undergoes fluctuation or not. Detailed supporting data presented at the Cambridge meeting suggested that these baseline and outcome parameters in the Ampligen(R) studies were relatively constant, both with respect to studies conducted in the U.S. as well as studies conducted in Europe.
All CFS patients described in the above chart met the Centers for Disease Control (CDC) criteria for the diagnosis of CFS and were studied under various regulatory authorizations obtained from either the U.S. Food and Drug Administration (FDA) and/or corresponding regulatory parties in the other countries. All patients entering the studies were included in the analysis. This data capture approach, termed "Intent to Treat" is intended to capture all relevant clinical information, including hardship in compliance with protocol requirements, etc. An "Intent to Treat" approach is generally considered the scientifically most rigorous approach in the analysis of clinical data on a prospective therapeutic drug. Also, under various regulatory guidelines and statutes operative in the U.S. and the European Union, clinical data developed in this manner, in support of a marketing application, meets the full regulatory standard of complete disclosure on all patients.
Hemispherx stated that it would shortly be issuing a similar status report with respect to a confirmatory Phase III clinical evaluation which is starting up in the U.S. and is a multi-center, randomized, double-blind, placebo-controlled protocol.
Hemispherx, headquartered in Philadelphia, PA, 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
-0- 10/19/98 /CONTACT: William A. Carter, M.D., CEO and Chairman, 215-988-0080, Sharon Will, Investor Relations, 212-572-0762, or Fax: 212-572-0764, both of Hemispherx Biopharma; or William J. Jenks, Media, 212-232-2222, Fax: 212-232-3232, for Hemispherx/
/Web site: hemispherx.com (HEB) CO: Hemispherx Biopharma ST: New York IN: MTC SU:
cav
|
