PHILADELPHIA, Feb 17, 2000 /PRNewswire via COMTEX/ -- Hemispherx Biopharma,
Inc. (Amex: HEB; HEBws) today announced that it has filed for HIV Emergency
Treatment IND and Phase II and Phase III trials with the Food and Drug
Administration.
The Company's new HIV Emergency Treatment IND application is intended to be used
to study the effects of Ampligen on the growing number of people with AIDS
(PWA's) who are developing resistance to their currently approved regimens, some
of whom have been left with no other clinical options. Hemispherx's Phase II and
Phase III trials are intended to study the effects of Ampligen in combination
with several Highly Active Antiretroviral Therapy (HAART) regimens, which have
been structured by Anderson Clinical Research.
"This is a very exciting development at a critical time in the epidemic when the
promise of Highly Active Antiretroviral Therapy has begun to fade," said Dr.
William A. Carter, Chairman and Chief Executive Officer of Hemispherx. "Clinical
trials and Emergency Treatment Protocols need to begin now to target the growing
number of patients who are quickly exhausting their therapeutic options."
These new filings follow the lead of other studies, which were presented at the
IBT Conference in Boston last December, that showed Ampligen is highly
synergistic with 12 of the 14 approved HIV medications. To date, Ampligen has
been studied in 126 patients and has been consistently well tolerated in its
trials. The new studies will evaluate not only the previous surrogate markers,
such as the improvements in Cell Mediated Immunity, but how Ampligen, in Immune
Base Therapy, may further reduce viral load in people with AIDS.
HEB's Web Site: hemispherx.com
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.
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