|March 26, 2003
|HEMISPHERX BIOPHARMA APPOINTS DAVID FEDORCZYK DIRECTOR OF CLINICAL AND STATISTICAL AFFAIRS
|History Of Successful Record In FDA Commercial Filings
Philadelphia, PA, Wednesday, March 26, 2003: Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that it has appointed David W. Fedorczyk, M.S. to the position of Director of Clinical and Statistical Affairs.
Mr. David Fedorczyk will direct the clinical and statistical activities required to complete the Company’s Phase III Clinical Trial AMP 516 for CFS (Chronic Fatigue Syndrome) and the two ongoing Phase IIb Clinical Trials, the AMP 719 for the treatment of HIV as a salvage therapy and the AMP 720 for the treatment of HIV as an S.T.I. (Strategic Treatment Interruption).
In announcing the appointment Dr. William A. Carter, President and CEO stated, “Mr. Fedorczyk is experienced in the management of all clinical research activities required from initiation through completion of clinical trials including, implementation of statistical operations for all phases of clinical trials, study design, protocol development, analysis plans, database management, SAS programming, statistical reporting function, and interaction with the FDA.
Mr. Fedorczyk most recently served as Director of Clinical and Statistical Affairs at Interferon Sciences, where he was responsible for all statistical and data management functions leading to FDA approval of the first human leukocyte derived alpha interferon in the United States for venereal warts, including statistical reports and integration with clinical summaries for FDA submissions, preparation and presentation of clinical data to the FDA Center for Biologics Evaluation and Research and direct interaction with the FDA throughout the review process to resolve issues related to clinical trial results.
David Fedorczyk received his MS in Statistics and his BA in Mathematics at the Rutgers College in New Brunswick, New Jersey. He is also a member of the American Statistical Association (ASA), the Biometrics Society, the Drug Information Association (DIA) and the Regulatory Affairs Professional Society (RAPS).
Hemispherx Biopharma, Inc.
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6223
Robert Giordano, MRB Investor Relations
(212) 495-0200, Ext. 10 Fax: (212) 495-0746
HEB's Web Site: www.hemispherx.net
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 risk of competition, changing market conditions, change 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. Any specifically referenced investigational drugs and associated technologies of the company (including AmpligenÒ and Oragensä) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic AlferonÒ do not imply that the product will be specifically approved commercially for these other treatment indications.