"Know how to bury your dead" Conference

2006/02/16 08:31:15
Alferon(R) LDO May Provide Defense against Avian Flu

PHILADELPHIA, Feb 16, 2006 (BUSINESS WIRE) -- Hemispherx Biopharma,
Inc. (AMEX: HEB):

-- Tests Indicate Potential of Ampligen(R) As Vaccine Adjuvant, Boosts
Existing Drugs Tamiflu(R), Relenza(R) Up To 100 Times; Alferon(R) LDO
Found to Stimulate Production of Interferon, Offering Natural Defense
Against Virus

-- Consortium of Researchers to Present Findings at Today's ASM
Biodefense Research Meeting in Washington, D.C.
Hemispherx Biopharma, Inc. (AMEX: HEB), a leader in the clinical
development and production of new drug entities for the treatment of
viral and immune-based chronic disorders, today unveiled the results of
laboratory testing that shows its two investigational immunotherapeutics,
Ampligen(R) and Alferon(R), are potentially useful against the H5N1, or
avian flu, virus.

The pre-clinical research indicates that Ampligen(R), a specifically
configured double-stranded RNA, can provide cross-protection against
avian flu viral mutations as well as boost the effectiveness of Tamiflu and
Relenza, the only two drugs formally recognized for combating bird flu,
up to 100 times. Other lab tests, in healthy human volunteers, indicate
that Alferon(R) LDO (Low-Dose Oral), a new delivery form of an anti-viral
with prior regulatory approval for a category of sexually transmitted
diseases, can stimulate genes that induce the production of interferon
and other immune compounds, key building blocks in the body's defense
system. Hemispherx Biopharma and collaborating government scientists
are presenting detailed findings at today's American Society for
Microbiology Biodefense Research Meeting in Washington, DC.

The results of an animal study conducted by Dr. Hideki Hasegawa, M.D.,
Ph.D., Chief, Laboratory of Infectious Disease Pathology at the National
Institute of Infectious Diseases in Tokyo, reveal that Ampligen(R) boosts
IgA antibody levels by up to 500% when co-administered with vaccine--
the exact antibodies that protect mucosal membranes of the nose and
mouth, the specific entry points of an invading avian flu virus. In the
course of the research, animals that were internasally administered with
the vaccine Ampligen(R) registered an increase in antibodies that could
fight the deadly virus. Some 80% of the Ampligen(R)-treated mice
survived the virus's onslaught, while none survived in a corresponding
placebo group.

"As indicated in earlier peer-review reports, double-stranded RNA
proved to be the most effective adjuvant for our nasal vaccine, and our
new research reveals that Ampligen(R) is the only non-toxic dsRNA that's
applicable to humans," said Dr. Hasegawa. "In addition, the alternative
method of delivery used in this study--nasal mist--also has potential
value. The tests suggest that not only does Ampligen(R) have the
potential to be an effective therapy against the virus by itself, but also
that the nasal mist method is far more economical, requiring only 1/20th
of the injection dosage. This means we can substantially expand the
supply and availability of this drug, and treat more people quickly and
effectively."
Independent lab research conducted at Utah State University under U.S.
National Institutes of Health (NIH) sponsorship indicates that Ampligen(R)
increases the efficacy of the two viral uptake inhibitors, Tamiflu and
Relenza. The lab studies suggest that 50 to 100 times less Tamiflu may
be used in conjunction with the experimental immunotherapeutic
Ampligen(R) to achieve full inhibition with no multiplication of the virus,
and no host cell damage. This may be a critical factor not only because of
the potential shortage of Tamiflu, but also because 18% of all children are
resistant to Tamiflu at conventional doses (as reported in the New
England Journal of Medicine, December 2005). The effect was found be
even stronger with Relenza (up to 500-fold potentiation) in the lab
experiments.

The experimental immunotherapeutic Alferon(R) N Injection is derived
from an FDA-approved treatment for the Human papillomavirus (HPV, or
genital warts). Hemispherx Biopharma has developed an oral delivery
format for the product that requires much lower doses, called Alferon(R)
LDO; new tests conducted in collaboration with the Cleveland Clinic
suggest it may stimulate a large bank of anti-viral immune genes that
may control the body's production of interferon and thereby potentially
fight a wide range of diseases, including avian flu.

"This is the race we have to win--to sufficiently mobilize the interferon
system early enough so that it will knock out the virus multiplication,"
said Professor Luc Montagnier, President of the Foundation for AIDS
Research and Prevention, who is widely credited with discovering the AIDS
virus, HIV. "I believe that in addition to the anti-viral effect, Alferon(R)
LDO will mobilize another important component of innate immunity, cells
able to eliminate infected cells. It will act both on the native avian virus
and on its humanized form."

Results from Phase 1/Phase 2 clinical trials in healthy volunteers, being
conducted at the Princess Margaret Hospital in Hong Kong indicate that
Alferon(R) LDO may strengthen human immune responses via interferon-
activated genes, potentially staving off infection should an individual be
thereafter exposed to the virus. By priming the body's own interferon
pump, Alferon(R) LDO might enable an infected host to produce enough
interferon to overcome the virus. The studies being reported today
include specific markers of immune response following exposure to
Alferon(R) LDO in the absence of any viral exposure.
"Given the potential for a pandemic, these results may have significant
implications for control of the avian flu virus," said William A. Carter,
M.D., Chairman and CEO of Hemispherx Biopharma. "In relevant animal
models and human volunteer studies, both experimental
immunotherapeutics, Ampligen(R) and Alferon(R) LDO may trigger the
production of novel defense products as part of the body's immune
system. Therefore, we are encouraged that these experimental
immunotherapeutics represent a significant new path forward in potential
preparation against the global spread."
Hemispherx Biopharma intends to file a new drug application (NDA) for
Ampligen(R) as a treatment for Chronic Fatigue Syndrome later this year.
Since Alferon(R) N Injection is already FDA-approved, Hemispherx
Biopharma would file various amendments globally to its existing
approval licenses, reflecting a different method of delivery and different
efficacy data on any potentially new therapeutic applications, including
avian flu.

About Hemispherx Biopharma
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical
company engaged in the manufacture and clinical development of new
drug entities for treatment of viral and immune-based chronic disorders.
Hemispherx Biopharma's flagship products include Alferon(R) and the
experimental immunotherapeutics/antivirals Ampligen(R) and Oragens
(TM). Alferon(R) is approved for a category of STD infection, and
Ampligen(R) and Oragens(TM) represent experimental nucleic acids being
developed for globally important viral diseases and disorders of the
immune system. Hemispherx's platform technology includes large and
small agent components for potential treatment of various chronic viral
infections. Hemispherx has in excess of 140 patents comprising its core
intellectual property estate, a fully commercialized product (Alferon(R) N)
and GMP certified manufacturing facilities for its novel pharma products.
For more information please visit www.hemispherx.net
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(R) 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(R) do not imply that
the product will ever be specifically approved commercially for these
other treatment indications.
SOURCE: Hemispherx Biopharma, Inc.

CONTACT: Hemispherx Biopharma, Inc. Dianne Will, 518-398-6222
ir@hemispherx.net or Media: Neale-May & Partners Digs Majumder,
212-213-5400 x 206 digs@nealemay.com

http://www.amex.com/?href=/newsDetails/CmnNewsDet.jsp?id=Xpr essFeed_NewsDetails_1140096675707.html

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Guests Members Profile Send Private Message Find Members Posts Add to Buddy List Guest Group	Post Options Post Reply Quote Guests Thanks(0) Quote Reply Topic: "Know how to bury your dead" Conference Posted: February 15 2006 at 1:31pm
	Preparing for pandemic: know how to bury your dead Wed Feb 15, 2006 (EXCERPT) MINNEAPOLIS, Feb 15 (Reuters) - When burying a body in the backyard, don't put it too close to the septic system. That was one piece of advice offered on Wednesday to a business conference on preparing for a potentially lethal bird flu andemic. Preparations for a global flu pandemic, which many experts believe is overdue, have begun but the grisly details are horrific and the number of sick could quickly overwhelm the health care system. Needed supplies of even common medical supplies such as surgical masks and gloves are in doubt, not to mention the syringes needed for an as-yet undeveloped vaccine and costly mechanical ventilators. The H5N1 avian flu virus that has infected flocks on at least three continents and killed 91 people could be the virus that experts fear will mutate into a highly pathogenic form that kills hundreds of millions of people in a matter of weeks or months. http://today.reuters.com/investing/financeArticle.aspx?type= bondsNews&storyID=2006-02-15T203832Z_01_N15235458_RTRIDST_0_ BIRDFLU-PANDEMIC.XML Edited by Rick

Guests Members Profile Send Private Message Find Members Posts Add to Buddy List Guest Group	Post Options Post Reply Quote Guests Thanks(0) Quote Reply Posted: February 16 2006 at 6:20am
	2006/02/16 08:31:15 Alferon(R) LDO May Provide Defense against Avian Flu PHILADELPHIA, Feb 16, 2006 (BUSINESS WIRE) -- Hemispherx Biopharma, Inc. (AMEX: HEB): -- Tests Indicate Potential of Ampligen(R) As Vaccine Adjuvant, Boosts Existing Drugs Tamiflu(R), Relenza(R) Up To 100 Times; Alferon(R) LDO Found to Stimulate Production of Interferon, Offering Natural Defense Against Virus -- Consortium of Researchers to Present Findings at Today's ASM Biodefense Research Meeting in Washington, D.C. Hemispherx Biopharma, Inc. (AMEX: HEB), a leader in the clinical development and production of new drug entities for the treatment of viral and immune-based chronic disorders, today unveiled the results of laboratory testing that shows its two investigational immunotherapeutics, Ampligen(R) and Alferon(R), are potentially useful against the H5N1, or avian flu, virus. The pre-clinical research indicates that Ampligen(R), a specifically configured double-stranded RNA, can provide cross-protection against avian flu viral mutations as well as boost the effectiveness of Tamiflu and Relenza, the only two drugs formally recognized for combating bird flu, up to 100 times. Other lab tests, in healthy human volunteers, indicate that Alferon(R) LDO (Low-Dose Oral), a new delivery form of an anti-viral with prior regulatory approval for a category of sexually transmitted diseases, can stimulate genes that induce the production of interferon and other immune compounds, key building blocks in the body's defense system. Hemispherx Biopharma and collaborating government scientists are presenting detailed findings at today's American Society for Microbiology Biodefense Research Meeting in Washington, DC. The results of an animal study conducted by Dr. Hideki Hasegawa, M.D., Ph.D., Chief, Laboratory of Infectious Disease Pathology at the National Institute of Infectious Diseases in Tokyo, reveal that Ampligen(R) boosts IgA antibody levels by up to 500% when co-administered with vaccine-- the exact antibodies that protect mucosal membranes of the nose and mouth, the specific entry points of an invading avian flu virus. In the course of the research, animals that were internasally administered with the vaccine Ampligen(R) registered an increase in antibodies that could fight the deadly virus. Some 80% of the Ampligen(R)-treated mice survived the virus's onslaught, while none survived in a corresponding placebo group. "As indicated in earlier peer-review reports, double-stranded RNA proved to be the most effective adjuvant for our nasal vaccine, and our new research reveals that Ampligen(R) is the only non-toxic dsRNA that's applicable to humans," said Dr. Hasegawa. "In addition, the alternative method of delivery used in this study--nasal mist--also has potential value. The tests suggest that not only does Ampligen(R) have the potential to be an effective therapy against the virus by itself, but also that the nasal mist method is far more economical, requiring only 1/20th of the injection dosage. This means we can substantially expand the supply and availability of this drug, and treat more people quickly and effectively." Independent lab research conducted at Utah State University under U.S. National Institutes of Health (NIH) sponsorship indicates that Ampligen(R) increases the efficacy of the two viral uptake inhibitors, Tamiflu and Relenza. The lab studies suggest that 50 to 100 times less Tamiflu may be used in conjunction with the experimental immunotherapeutic Ampligen(R) to achieve full inhibition with no multiplication of the virus, and no host cell damage. This may be a critical factor not only because of the potential shortage of Tamiflu, but also because 18% of all children are resistant to Tamiflu at conventional doses (as reported in the New England Journal of Medicine, December 2005). The effect was found be even stronger with Relenza (up to 500-fold potentiation) in the lab experiments. The experimental immunotherapeutic Alferon(R) N Injection is derived from an FDA-approved treatment for the Human papillomavirus (HPV, or genital warts). Hemispherx Biopharma has developed an oral delivery format for the product that requires much lower doses, called Alferon(R) LDO; new tests conducted in collaboration with the Cleveland Clinic suggest it may stimulate a large bank of anti-viral immune genes that may control the body's production of interferon and thereby potentially fight a wide range of diseases, including avian flu. "This is the race we have to win--to sufficiently mobilize the interferon system early enough so that it will knock out the virus multiplication," said Professor Luc Montagnier, President of the Foundation for AIDS Research and Prevention, who is widely credited with discovering the AIDS virus, HIV. "I believe that in addition to the anti-viral effect, Alferon(R) LDO will mobilize another important component of innate immunity, cells able to eliminate infected cells. It will act both on the native avian virus and on its humanized form." Results from Phase 1/Phase 2 clinical trials in healthy volunteers, being conducted at the Princess Margaret Hospital in Hong Kong indicate that Alferon(R) LDO may strengthen human immune responses via interferon- activated genes, potentially staving off infection should an individual be thereafter exposed to the virus. By priming the body's own interferon pump, Alferon(R) LDO might enable an infected host to produce enough interferon to overcome the virus. The studies being reported today include specific markers of immune response following exposure to Alferon(R) LDO in the absence of any viral exposure. "Given the potential for a pandemic, these results may have significant implications for control of the avian flu virus," said William A. Carter, M.D., Chairman and CEO of Hemispherx Biopharma. "In relevant animal models and human volunteer studies, both experimental immunotherapeutics, Ampligen(R) and Alferon(R) LDO may trigger the production of novel defense products as part of the body's immune system. Therefore, we are encouraged that these experimental immunotherapeutics represent a significant new path forward in potential preparation against the global spread." Hemispherx Biopharma intends to file a new drug application (NDA) for Ampligen(R) as a treatment for Chronic Fatigue Syndrome later this year. Since Alferon(R) N Injection is already FDA-approved, Hemispherx Biopharma would file various amendments globally to its existing approval licenses, reflecting a different method of delivery and different efficacy data on any potentially new therapeutic applications, including avian flu. About Hemispherx Biopharma Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Hemispherx Biopharma's flagship products include Alferon(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens (TM). Alferon(R) is approved for a category of STD infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important viral diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon(R) N) and GMP certified manufacturing facilities for its novel pharma products. For more information please visit www.hemispherx.net 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(R) 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(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications. SOURCE: Hemispherx Biopharma, Inc. CONTACT: Hemispherx Biopharma, Inc. Dianne Will, 518-398-6222 ir@hemispherx.net or Media: Neale-May & Partners Digs Majumder, 212-213-5400 x 206 digs@nealemay.com http://www.amex.com/?href=/newsDetails/CmnNewsDet.jsp?id=Xpr essFeed_NewsDetails_1140096675707.html