Nobel Laureate Confirms Importance of Adjuvants in Controlling Devastating Diseases
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PHILADELPHIA, Oct. 23, 2008 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.
(AMEX:HEB) noted today that a member of its Scientific Advisory Board, Prof. Luc
Montagnier, a winner of the 2008 Nobel Prize in Physiology and Medicine,
confirms the importance of adjuvants in a current article in the Wall Street
Journal (Oct. 21, 2008, p.A19). In his article entitled "The Next Steps to Take
in Beating AIDS", Prof. Montagnier, indicates that "after partial restoration
(...of the patient's immune system) by an antiretroviral treatment...at the same
time the immune system should be fully restored with proper adjuvants."
Hemispherx's experimental biotherapeutic, Ampligen(r), is a well studied
adjuvant which selectively produces maturation of key components of the immune
system necessary to bring about "immunosurveillance". This experimental
biotherapeutic appears to operate exclusively thru a set of naturally occurring
alarm signals on human cells termed "TLR3 receptors". In his article, Prof.
Montagnier emphasizes the need to induce natural immunity to "remove the burden
of life-long drug therapy and prevent HIV infection from evolving into a
disease". As a further illustration, he suggests: "We want to extend what Mother
Nature bestows upon a few lucky individuals (infection without disease) to a
majority of patients."
Hemispherx has recently submitted a New Drug Application (NDA) for potential use
of the experimental product Ampligen(r) to treat Chronic Fatigue Syndrome (CFS)
in the U.S., to be discussed at the upcoming ICAAC Conference in Washington,
D.C.
Prof. Montagnier is also a long term advocate of the potential use of another
Hemispherx experimental biotherapeutic, Alferon LDO, in catastrophic viral
infections, such as HIV, especially for developing African nations. Earlier,
referring to the recent threat of avian influenza in Forbes.com, Prof.
Montagnier commented: "This is the race we have to win: to sufficiently mobilize
the interferon system early enough so it will knock out the virus multiplication
before the virus launches its dangerous missile against interferons. One prime
candidate for this task already exists. It's a substance called Alferon LDO."
Alferon LDO, (Low Dose Oral Interferon Alfa-n3, Human Leukocyte Derived), is
Hemispherx's experimental, oral-delivery form of the Company's FDA-approved
drug, Alferon N Injection(r), indicated for treatment of refractory HPV
infection. Alferon N is the only natural interferon which is FDA approved for
any disease. As part of its mechanism of action, Alferon N also serves as a
"co-stimulatory" molecule to increase the robustness of "immuno-surveillance" to
reduce the chance of disease recurrence.
Hemispherx has initiated clinical trials as part of an evaluation of Alferon LDO
as a potential new experimental therapy for HIV/AIDS and other lethal viral
diseases including avian influenza ("bird flu"), which have very high death
rates. Clinical trials in early HIV infection have been conducted in the U.S.
with the AIDS research organization termed "Philadelphia Fight", as well as in
Hong Kong at the Princess Margaret Hospital utilizing Alferon LDO with healthy
volunteers to measure natural immune boosting capabilities. Overall, the studies
are designed to determine whether Alferon LDO, delivered in the new,
experimental oral (sublingual) drug delivery format can resuscitate the
broad-spectrum antiviral and immunostimulatory genes. These human genes are
often shut down by lethal viral infections such as avian flu, smallpox, and
HIV/AIDS as noted in Dr. Montagnier's article in Forbes.com.
Recent studies conducted at the Japanese National Institutes of Infectious
Diseases have also established that Ampligen(r), an experimental therapeutic,
can function as an effective adjuvant by various routes of administration
including oral (intranasal) delivery.
Dr. Montagnier is Chairman of the World Foundation for AIDS Research and
Prevention, which he co-founded in 1993, and holds the position of Distinguished
Professor at Queens College in New York.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma 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(r) (FDA approved for a category of sexually transmitted diseases)
and the experimental therapeutics, Ampligen(r) and Oragens. Ampligen(r) and
Oragens represent experimental RNA nucleic acids being developed for globally
important debilitating diseases and disorders of the immune system. Hemispherx's
platform technology includes large and small agent components for potential
treatment of various severely debilitating and life threatening diseases.
Hemispherx has in excess of 90 issued patents comprising its core intellectual
property estate and a fully commercialized product (Alferon N Injection(r)). 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.
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 Ampligen(r), Alferon LDO and Oragens) 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 Alferon
N Injection(r) do not imply that the product will ever be specifically approved
commercially for these other treatment indications; similarly, the completion of
the NDA filing process with Ampligen(r) does not imply that the product will
ever be approved commercially.
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CONTACT: Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
CCG Investor Relations
Sean Collins, Sr. Partner
310-477-9800
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