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Hemispherx Biopharma Announces 9th Clinical Investigators Conference: Ampligen Clinical Trials Highlighted

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.

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