Hemispherx Biopharma and Bioclones Join Forces in Effort to Eradicate HIV/AIDS
Virus Based on Recent Clinical Insights of Wistar Institute, University of
Patients Receiving Alpha Interferon May go Into Long Term Remission After
Initial HAART (Highly Active Anti-Retroviral Therapy) Therapy is Discontinued
PHILADELPHIA, July 8, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.
(NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced execution of an
agreement to seek South African government approval to initiate a study of
Alferon® N, the only FDA approved natural interferon, in the suppression of
HIV Type 1 replication and the reduction/elimination of functional
cell-associated HIV DNA integration (latent HIV). The study is contemplated as
part of a broad strategic alliance with Bioclones (Pty) Ltd. ("Bioclones"), a
leading South African biotechnology company.
At the Wistar Institute, University of Pennsylvania, a recent clinical study
was conducted to test the effect of Interferon Alfa-2a in the suppression
and/or eradication of HIV (Pegylated Interferon Alfa-2a Monotherapy Results in
Suppression of HIV Type I Replication and Decreased Cell-Associated HIV DNA
Integration; Azzoni, et al. J Infect Dis, 207:213-222, 2013). This pilot study
yielded an exciting conclusion: alpha interferon resulted in control of HIV
replication in 45% of patients following cessation of anti-retroviral therapy.
Decreased levels of latent HIV (chromosomal integrated HIV provirus
responsible for chronic infection non-responsive to current approved
anti-retroviral drugs) occurred in patients in which HIV replication was
suppressed by anti-retroviral drugs, supporting a role for immune-mediated
approaches in HIV suppression and potential eradication of latent virus
required for cure. Hemispherx' flagship products, Alferon® N and Ampligen®
(experimental) are both potentially key players in successful long-term
Hemispherx' product, Alferon® N, is a natural interferon that has certain
apparent advantages over recombinant (synthetic) interferons. First, unlike
synthetic alpha interferons which typically are single species, Alferon® N is
a multi-species alpha interferon. In a side-by-side clinical comparison, it
has a superior safety profile relative to a commercially available synthetic
interferon and can be successfully used in the treatment of certain refractory
patients. In some studies, Alferon® N produces more antiviral control (Fan, et
al, AIDS Research and Human Retroviruses, 9(11):1115-1122, 1993) and less
neutralizing antibody formation compared to synthetic interferons (Strayer and
Carter, J IFN and Cytokine Res, 32(2):95-101, 2012). It is the only natural
source alpha interferon product currently approved by the FDA in the U.S.
Alferon® N is also approved for sale in Argentina for an unrestricted
indication of patients that fail or become intolerant to treatment with
Hemispherx and Bioclones will co-sponsor the clinical study of the safety and
biological effects, including clinical, immunologic, and virologic
assessments, of adding Alferon® N to a strategic therapeutic intervention
protocol in 30 South African patients with HIV. Bioclones, a global partner to
Hemispherx, will serve as the Company's South African representative and will
organize the trials to take place in South Africa.
In the Wistar article, Interferon Alfa-2a immunotherapy resulted in control of
HIV replication and decreased levels of HIV-1 integrated provirus, supporting
a role for immune-mediated approaches in HIV suppression and/or eradication.
The objective of the Bioclones/Hemispherx program is to build on the Wistar
results by increasing the complete response rate.
Ismet Amod, CEO of Bioclones, stated, "From a global perspective Bioclones
will be able to provide an African context for the use of both Alferon® in the
fight against the HIV AIDS virus for the first time in South Africa and both
our companies are committed to advancing the cause against the spread of the
HIV AIDS virus and make a difference in the lives of all that are affected by
Thomas Equels, Executive Vice Chairman of Hemispherx, stated, "Hemispherx is
pleased to co-sponsor upcoming clinical trials in South Africa using Alferon®
N in the treatment of patients with HIV. Together with Bioclones, we look
forward to seeking authority from the South African government to commence the
trials as soon as possible. Both of our companies are ready to bring our
talents to the global fight to eradicate AIDS."
Bioclones is a South African-owned biotechnology company dedicated to the
manufacture of modern biotechnology products for human pharmaceutical use as
well as the development of biotechnology infrastructure and skills across the
African continent. It was established in 1982 and is the largest biotechnology
company in this field in South Africa.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company
engaged in the manufacture and clinical development of new drug entities for
treatment of seriously debilitating disorders. Hemispherx's flagship products
include Alferon N Injection® and the experimental therapeutics Ampligen® and
Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed
for globally important debilitating diseases and disorders of the immune
system, including Chronic Fatigue Syndrome. Hemispherx's platform technology
includes components for potential treatment of various severely debilitating
and life threatening diseases. Because both Ampligen® and Alferon® LDO are
experimental in nature, they are not designated safe and effective by a
regulatory authority for general use and are legally available only through
clinical trials. Hemispherx has patents comprising its core intellectual
property estate and a fully commercialized product (Alferon N Injection®),
approved for sale in the U.S. and Argentina. The Company's Alferon® N approval
in Argentina includes the use of Alferon N Injection® (under the brand name
"Naturaferon") for use in any patients who fail or become intolerant to
recombinant interferon, including patients with chronic active hepatitis C
infection. The Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial products. For more
information please visit www.hemispherx.net.
To the extent that statements in this press release are not strictly
historical, all such statements are forward-looking, and are made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. Words such as "intends," "plans," and similar expressions are intended
to identify forward-looking statements. The inclusion of forward-looking
statements should not be regarded as a representation by Hemispherx that any
of its plans will be achieved. These forward-looking statements are neither
promises nor guarantees of future performance, and are subject to a variety of
risks and uncertainties, many of which are beyond Hemispherx's control, which
could cause actual results to differ materially from those contemplated in
these forward-looking statements. Examples of such risks and uncertainties
include those set forth in the Disclosure Notice, below, as well as the risks
described in Hemispherx's filings with the Securities and Exchange Commission,
including the most recent reports on Forms 10-K, 10-Q and 8-K. You are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof, and Hemispherx undertakes no
obligation to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise revise or update this release to reflect events or
circumstances after the date hereof.
The information in this press release includes certain "forward-looking"
statements including without limitation statements about the ability to gain
the South African government approval to initiate a study of Alferon® N, the
only FDA approved natural interferon, in the suppression of HIV Type 1
replication and the reduction/elimination of functional cell-associated HIV
DNA integration (latent HIV) in South Africa and other countries.
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, 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. The final results of these efforts and/or any other activities
could vary materially from Hemispherx's expectations.
CONTACT: Company/Investor Contact:
CJones & Associates Public Relations
Press spacebar to pause and continue. Press esc to stop.