| June 14, 2001 |
| HEMISPHERX BIOPHARMA INITIATES TREATMENT IN TWO NEW CLINICAL STUDIES OF MULTI-DRUG RESISTANT HIV-INFECTION IN U.S.A.--Culminates 15 Year Period of Discoveries- |
Philadelphia, PA, Thursday, June 14, 2001: Hemispherx Biopharma, Inc. (AMEX: HEB; HEBws) announced the commencement of treatment cycles in two new Phase IIb clinical trials designed to overcome, and/or prevent, multi-drug resistant HIV. The two FDA-authorized clinical trials with Ampligen®, an investigational agent with both immunological and antiviral potential, have been designated REARM 1 and REARM 2.
REARM 1 and REARM 2 address two central questions in AIDS clinical research today - whether antiviral activity against mutated HIV can be improved by novel additions to currently approved drug regimens and whether immune reconstitution can occur in this therapeutic setting. The programs will enroll over 250 HIV-infected individuals utilizing prestigious Medical Centers and AIDS clinical research expertise in both the East and West Coasts of the U.S.A. Complementary clinical programs are also immediately planned for the European Union (EU) community by the sister Company, Hemispherx Biopharma Europe.
Detailed clinical enrollment criteria, for interested physicians and AIDS health care specialists, will be posted shortly on the Company's new website presently being launched.
According to various third party sources, up to 50% of the HIV infected individuals in both North America and the EU have already developed mutant strains of HIV.
Ampligen® represents a new class of nucleic acid (RNA, or ribonucleic acid) technologies as potential therapeutic products for disorders of the human immune system. The present studies REARM 1 and REARM 2 culminate a 15 year period of drug discovery, laboratory investigations and Phase I, II, III clinical trials.
Contact(s):
William A. Carter, M.D., CEO & Chairman, Hemispherx Biopharma, Inc. (215) 988-0080
Robert Giordano, Institutional Investors, KCSA, (212) 682-6300, Fax: (212) 697-0910
Dianne Will, Investor Relations, (518) 398-6222, Fax: (518) 398-6223
HEB's Web Site: www.hemispherx.net
Information contained in this news release other than historical information, including the referenced REARM 1 and REARM 2 clinical programs, should all be considered forward-looking and are 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. Additionally, all the referenced investigational drugs and associated technologies of the company 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 judgement as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
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