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Clinical Investigators Conference: Ampligen clinical trials highlighted
Wednesday 9 March 2011
Hemispherx Biopharma Announces 9th Clinical Investigators Conference: Ampligen Clinical Trials Highlighted
Conference Explores Potential Relationships Between Chronic Fatigue Syndrome (CFS) and a Novel Retrovirus
PHILADELPHIA, March 7, 2011 (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®, 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® 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®, an experimental therapeutic, was reviewed, including his recent peer reviewed publications. This work in animals, including non-human primates, demonstrated that Ampligen® 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®. 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®.
Dr. Lupe Salanzar, Assistant Professor of Medicine, Oncology, University of Washington, presented on the Application of Ampligen® Augmentation Mechanisms to Ongoing Phase II Breast Cancer Vaccine Trials (HER2). Dr. Salanzar presented data indicating that Ampligen® 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® 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® on the conversion of immature to mature dendritic cells, a process essential in the establishment of immune responses. Dr. Nicodemus discussed Ampligen®'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® 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® may provide an enhancement of certain novel vaccines under development. Dendreon Corporation received the first FDA approval for a cancer vaccine therapeutic, Provenge®, 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® 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
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® and Alferon® 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® 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.
The above originally appeared here.
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