PDF   Print   View All
December 17, 2002
Hemispherx Presents New Data from Phase IIB Clinical Trial of RNA-based Ampligen® for Structured Treatment Interruption in HIV at DART Conference
Ampligen® Study Indicates Prolonged Time Off AIDS Drugs Without Viral Rebound

Philadelphia, PA, Tuesday, December 17, 2002: Hemispherx Biopharma Inc. (Amex:HEB) today presented new data from a Phase IIB clinical trial of its experimental compound, RNA-based Ampligen®, on Structured Treatment Interruption (STI) in HIV. Gary Blick, M.D. and Hemispherx’s Clinical Director, David Strayer, M.D., discussed the results at the Frontiers in Drug Development for Antiretroviral Therapies (DART) Conference in Naples, Florida.

The data suggest a prolongation of time off Highly Active Antiretroviral Therapy (HAART) without significant viral rebound when taking Ampligen® vs. control (median of 15+ weeks, mean of 25+ weeks off HIV medication with Ampligen® vs. 7 weeks median and 13 weeks mean without Ampligen®).

The AMP 720 study evaluates effects of RNA-based Ampligen® under STI, when patients are taken off HAART drugs – AIDS “cocktails” – and remain on Ampligen alone. “A ‘vacation’ from HAART may help avoid long-term toxicities and may enable the body to heal from drug-induced damage,” said Dr. Blick.

The presentation, entitled, “A Phase IIB Prospective, Randomized, Controlled Study Evaluating the Immunomodulatory Role of Poly I:Poly C12U Against HIV During STI,” discussed the results from the study ongoing at eight sites around the county. The DART conference assembles leading AIDS researchers worldwide at its semi-annual meeting.


The experimental compound, RNA-based Ampligen®, acts by a mechanism proposed to stimulate the body’s own immune defenses and also may attack the virus. More than 50,000 doses of Ampligen® have been administered in studies at 20+ clinical trial sties. Ampligen® is an experimental, investigational drug and, as such, is not designated as safe or effective by a regulatory authority for general use and is legally available only through clinical trials.

About Hemispherx

Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company 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, HIV, CFS and Hepatitis. Its platform technology includes large and small agent components for potential treatment of various chronic viral infections. For more information visit the company’s Web sit at www.hemispherx.net.


Contact(s):
Hemispherx Biopharma, Inc., Investor Relations
Dianne Will
(518) 398-6222, Fax: (215) 988-1554 or (518) 398-6223

Wesley Stanton, MRB Institutional Investors, MRB
(212) 495-0200, ext. 11 Fax: (212) 495-0746

MEDIA:
Robbin Wagge, Rubenstein Associates, Inc.
(212) 843-8006
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. Accordingly, 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 judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.