Hemispherx Biopharma, Inc.
08.03.2011 09:00
---------------------------------------------------------------------------
Conference Explores Potential Relationships Between Chronic Fatigue Syndrome
(CFS) and a Novel Retrovirus
PHILADELPHIA, 2011-03-08 09:00 CET (GLOBE NEWSWIRE) --Hemispherx Biopharma,
Inc. (NYSE:HEB) ('Hemispherx' or the 'Company') announced
that the Company conducted its 9th Clinical Investigators Conference held March
3-6, 2011 in Islamorada, Florida, attended by a variety of prominent clinicians
and scientists. The experimental drug, Ampligen(r), is being tested as a
potential therapeutic for CFS and a vaccine enhancer in both cancer and viral
disease including pandemic flu. Various independent researchers presented their
experiences and findings.
Dr. Luc Montagnier, Nobel Laureate in Physiology and Medicine for the discovery
of the HIV/AIDS virus, discussed a number of retroviral topics including
mechanisms of genetic variability and the problem of HIV reservoirs in the
elimination of HIV despite targeted retroviral therapy. Dr. Judy Mikovits,
Research Director, Whittemore Peterson Institute for Neuro-Immune Disease,
presented a detailed review of the discovery of XMRV ('Xenotropic Murine
Leukemia Virus') and MLV ('Murine Leukemia Viruses') variants found in CFS, as
well as new data on these variants. The XMRV genome may contain a hormonal
response element that may explain the disorder of the adrenal stress response
pathway in some patients with CFS. Dr. Mikovits also discussed a cellular
resistance mechanism as a possible human genetic factor in XMRV infection. Dr.
Maureen Hanson, Professor, Department of Molecular Biology & Genetics, Cornell
University, presented corroborating results of her analytical work with Dr.
David Bell on the presence of XMRV markers in a pediatric CFS cohort. She
further provided an analysis of the relative sensitivities of PCR ('Polymerase
Chain Reaction') markers of potential mouse contamination that should be used
in PCR assays for XMRV and other related murine retroviruses in human samples.
Dr. Frank Ruscetti of the National Institutes of Health (NIH) reviewed the
evidence for an association between XMRV and prostate cancer.
Dr. Howard Urnovitz of Chronix Biomedical in San Jose, CA and Gottingen,
Germany, presented information on 'Next Generation Sequencing (NGS)' of serum
DNA as a prognostic marker in cancer and neurogenerative diseases. The Chronix
team used sequencing to assess whether there may be unique serum DNA sequences
in the peripheral blood of patients with CFS. Dr. Lucinda Bateman, Director,
Fatigue Consultation Clinic, Salt Lake City, UT, and Dr. Charles Lapp, Medical
Director, Hunter-Hopkins Center, Charlotte, NC, both long term leading
clinicians in CFS therapy, provided overviews of the potential value of
developing assays for XMRV on CFS diagnosis and therapy. Dr. Pablo Beretta,
Founder of the PHI Institute, a specialized center for research in CFS and
Fibromyalgia in Argentina, provided a detailed presentation on the clinical
management of CFS in Argentina, with an analysis of various viruses associated
with CFS.
The discussions then moved to the progress with Ampligen(r) as an immune
enhancing compound for both cancer and viral vaccines. The published work of
Dr. Hasegawa, Chief, Laboratory of Infectious Diseases, National Institute of
Infectious Diseases (NIID) in Japan, regarding the pandemic H5N1 flu vaccine
delivered intra-nasally along with Ampligen(r), an experimental therapeutic, was
reviewed, including his recent peer reviewed publications. This work in
animals, including non-human primates, demonstrated that Ampligen(r) may
contribute significantly to eliciting a protective immune response against
highly pathogenic avian H5N1. Of significant interest is the elicitation of
protective immune responses against avian H5N1 in mice with a seasonal
influenza vaccine co-administered intra-nasally with Ampligen(r). Dr. Zhongkai
Shi, Director of Research & Development, Vaxin Inc., presented Vaxin's
recombinant vaccine technology for nasally delivered flu vaccines, both
seasonal and pandemic, using an adenovirus vector. Dr. Shi also described the
design of a proposed Phase I/II human volunteer clinical study of Vaxin's
recombinant H5N1 nasal vaccine, NasoVax, in conjunction with the experimental
therapeutic, Ampligen(r).
Dr. Lupe Salanzar, Assistant Professor of Medicine, Oncology, University of
Washington, presented on the Application of Ampligen(r) Augmentation Mechanisms
to Ongoing Phase II Breast Cancer Vaccine Trials (HER2). Dr. Salanzar presented
data indicating that Ampligen(r) may enhance the immune response in their well
established experimental human breast cancer vaccine. Dr. Salanzar also
reported on their pending Phase II clinical study of Breast Cancer Vaccine
Trials (HER2) with Ampligen(r) at the Fred Hutchinson Comprehensive Cancer
Center. Dr. Chris Nicodemus, Chairman & Chief Scientific Officer, Advanced
Immune Therapeutics, Inc., presented a review of the effect of Ampligen(r) on
the
conversion of immature to mature dendritic cells, a process essential in the
establishment of immune responses. Dr. Nicodemus discussed Ampligen(r)'s
potential application in immunotherapeutic vaccines for both ovarian and
pancreatic cancer. A proposed clinical collaboration between Hemispherx and Dr.
George Coukos, Professor, Ovarian Cancer Center, at the University of
Pennsylvania, combining Ampligen(r) with a novel autologous ovarian cancer
vaccine, was also presented. Finally, Dr. Craig Meagher, representative of the
Dendreon Corporation, commented on initial laboratory data suggesting that
Ampligen(r) may provide an enhancement of certain novel vaccines under
development. Dendreon Corporation received the first FDA approval for a cancer
vaccine therapeutic, Provenge(r), in 2010.
Dr. Cynthia Lemere, Associate Professor of Neurology, Harvard Medical School,
Center for Neurologic Diseases, presented a proposed study of the intranasal
application of Ampligen(r) co-administered with experimental vaccines for
neurological diseases. Her earlier work suggested that intra-nasally
administered TLR compounds co-administered with vaccines may be useful in
ameliorating symptoms of Alzheimer's Disease in an animal model.
During the meeting, the Wall Street Journal (March 5, 2011 issue entitled 'The
Puzzle of Chronic Fatigue') provided a comprehensive overview of potential
retro-viral etiology focusing on CFS patients studied by Drs. Hanson and Bell.
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(r) (FDA approved for a category of sexually
transmitted diseases) and the experimental therapeutics Ampligen(r) and
Alferon(r)
LDO. Ampligen(r) is an experimental RNA nucleic acid being developed for
globally
important debilitating diseases and disorders of the immune system.
Hemispherx's platform technology includes components for potential treatment of
various severely debilitating and life threatening diseases. Hemispherx has
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) and Alferon(r) LDO) 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.
Certain of the potential studies mentioned are only in the pre-clinical stage
and they may or may not occur, and some of the findings discussed are
preliminary and subject to required additional testing. The planning,
completion, results or submission of clinical trials do not imply that any
study product will ever be approved commercially for the studied or other
treatment indications.
CONTACT: Dianne Will
Hemispherx Biopharma, Inc.
518-398-6222
ir@hemispherx.net
News Source: NASDAQ OMX
08.03.2011 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Hemispherx Biopharma, Inc.
US
Phone:
Fax:
E-mail:
Internet:
ISIN: US42366C1036
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------
DGAP-News: Hemispherx Biopharma Announces 9th Clinical Investigators Conference: Ampligen Clinical Trials Highlighted
| Source: EQS Group AG