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NexBio Completes Clinical Advisory Board for the Advanced Development of DAS181 (Fludase(R)*), a First-In-Class Medicine for Influenza

SAN DIEGO, April 15 /PRNewswire/ -- NexBio, Inc. announced today that it has completed the formation of a new Clinical Advisory Board (CAB) to complement its existing group of Senior Advisers. NexBio recently completed a First-In-Man clinical trial of DAS181 (Fludase(R)), an investigational drug candidate for influenza. The new CAB will guide NexBio throughout the clinical development of this novel medicine, helping the company to conduct advanced product development to address the threat of a potential influenza pandemic. The CAB is chaired by Andrew Pavia, M.D., who is joined by Robert Belshe, M.D., Kathryn Edwards, M.D., Allison McGeer, M.D., FRCPC, and Richard Whitley, M.D.

"These individuals are among the most highly regarded thought leaders in the field of clinical development of drugs for respiratory viral infections," said Ron Moss, M.D., NexBio's Executive Vice President, Clinical Development & Medical Affairs. "We expect that their depth of knowledge and experience will contribute enormously to the goal of developing Fludase for the prevention and treatment of Influenza-Like Illness caused by influenza, parainfluenza, and potential pandemic strains such as H5N1. With the development of drug resistance to currently licensed antivirals, our distinguished CAB recognizes the importance of determining the clinical utility of DAS181 against emerging strains of influenza."

Dr. Pavia is the George and Esther Gross Presidential Professor and Chief of the Division of Pediatric Infectious Diseases at the University of Utah Health Sciences Center. He is very active as an infectious disease investigator and in policy. Dr. Pavia serves on several advisory committees for federal and state government on vaccine policy, biodefense, and pandemic influenza preparedness. He leads several committees of the Infectious Diseases Society of America and has been a member of the Institute of Medicine Committee on "Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program." Dr. Pavia's research interests include the epidemiology of influenza and other emerging infections; he has published more than 100 scientific articles and chapters. He also has significant experience in the clinical development of antiviral compounds.

Dr. Belshe is the Dianna and J. Joseph Adorjan Endowed Professor of Infectious Diseases and Immunology; Professor of Medicine, Pediatrics and Molecular Microbiology, and Director for the Division of Infectious Diseases and Immunology, at the St. Louis University School of Medicine. He has published numerous key clinical articles on influenza vaccines and pathogenesis of influenza.

Dr. Edwards holds the Sarah H. Sell Endowed Professorship in Pediatrics at Vanderbilt University School of Medicine. She has completed several peer review publications and published many pivotal articles on infectious disease, influenza vaccines and pathogenesis, and parainfluenza in pediatric patients. Dr. Edwards is a current National Institute of Allergy and Infectious Diseases (NIAID) Advisory Council member and has been awarded multiple grants.

Dr. McGeer is a Professor of Laboratory Medicine and Pathobiology at the University of Toronto and Director of Infection Control and a Microbiologist at the Mount Sinai Hospital, Toronto. Dr. McGeer is a practicing clinician and has served on expert committees including the Council of Canadian Academies Expert Panel on Influenza and Respiratory Protection, and the Canadian National Advisory Committee on Immunization.

Dr. Whitley is the Loeb Eminent Scholar Chair in Pediatrics; Professor of Pediatrics, Microbiology, Medicine and Neurosurgery; Co-Director, University of Alabama at Birmingham Center for Emerging Infections and Emergency Preparedness; Director, Division of Pediatric Infectious Diseases; and Vice- Chairman, Department of Pediatrics. Dr. Whitley has served on several editorial and advisory boards and is currently the Vice President and President Elect for the Infectious Disease Society of America. Since 1980 Dr. Whitley has served as the Project Director for NIAID's Collaborative Antiviral Study Group, a multi-center clinical trial network directed to conduct studies to evaluate novel antiviral therapies that target unmet medical needs.

    More information on each CAB member may be found on the company's web site.


NexBio, Inc. is a privately held development-stage biopharmaceutical company located in San Diego. NexBio's mission is to save lives and to improve the quality of life by creating and commercializing novel, broad-spectrum biopharmaceuticals to prevent and treat current and emerging life-threatening diseases. DAS181 (Fludase(R)), a recombinant fusion protein, inactivates viral receptors on the cells of the human respiratory tract, thereby preventing influenza, including potential pandemic strains, and parainfluenza viruses (which may cause serious respiratory illness similar to influenza and for which there is no approved vaccine or therapeutic) from infecting the human body or from amplifying in infected individuals. Unlike current antiviral compounds and vaccines, DAS181 targets human host receptors, not virus components, and thus carries a reduced risk of drug resistance compared with the currently available antiviral drugs. Extensive, prolonged nonclinical studies have not shown the development of any meaningful resistance. Furthermore, DAS181 has been shown effective against influenza that is resistant to Tamiflu(R). The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Viradin(TM), invented and developed by NexBio, is a parenteral protein under development, currently at lead optimization stage, directed to the treatment of viral hemorrhagic fever caused by viruses such as Ebola and Marburg, as well as the treatment of sepsis and septic shock. TOSAP(TM) is a microparticle formulation technology invented and developed by NexBio, used to formulate DAS181 for inhalation, as well as other NexBio compounds and compounds of partners, under license.

For more information about NexBio, Inc., please visit


     David Wurtman, M.D., M.B.A
     VP, Corporate Development
     10665 Sorrento Valley Road
     San Diego, CA  92121
     Phone: (858) 452-2631

    * FDA has yet to approve the name Fludase.


This release contains forward-looking information about the research and development program of NexBio and the potential efficacy of product candidates that might result from programs that involve substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development activities; decisions by regulatory authorities regarding whether and when to permit the clinical investigation of or approve any drug applications that may result from the programs as well as their decisions regarding labeling and other matters that could affect the commercial potential of product candidates that may result from the program; and competitive developments.

SOURCE NexBio, Inc.
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