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NexBio(R) Presents DAS181 (Fludase(R)*) Potently Inhibits Novel Swine-Origin A(H1N1) and NAI-Resistant Influenza Viruses, at ICAAC 2009
Date:9/13/2009

SAN DIEGO, Sept. 13 /PRNewswire/ -- NexBio, Inc. announced today the presentation of two studies of DAS181 activity against H1N1 influenza and NAI-resistant influenza at the 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting on Sunday, September 13, 2009, in San Francisco, CA. The work was performed in collaboration with researchers at the Centers for Disease Control and Prevention (CDC), University of Hong Kong, and Saint Louis University.

DAS181 (Fludase(R)) is an investigational broad spectrum drug candidate being evaluated in human clinical development for treatment and prevention of Influenza-Like Illness caused by all strains of influenza and parainfluenza. Unlike neuraminidase inhibitors (NAI), e.g. Tamiflu(R), which directly target the influenza virus ("pathogen target"), DAS181 works by inactivating the human receptor ("host target") for these viruses; thus, it may be less likely to encounter acquired resistance compared with currently-available antiviral drugs. Extensive, prolonged nonclinical influenza studies have not shown the development of any meaningful resistance. This approach may have advantages over mono-therapy or combination therapy which directly target the pathogen. Previously announced preclinical studies conducted in collaboration with the CDC and others have shown DAS181 to have significant therapeutic and prophylactic activity in in vivo animal models and in human ex vivo lung tissue for a highly virulent H5N1 (A/VN/1203/04) strain of influenza.

A "Late Breaker" presentation, entitled "Novel Swine-Origin A (H1N1) Influenza Viruses are Potently Inhibited by DAS181, a Sialidase Fusion Protein" examined in vitro, ex vivo, and in vivo models to evaluate the activity of DAS181 against multiple human novel 2009 influenza A/H1N1 viruses (Novel H1N1 or "Swine Flu"). The data presented at the meeting suggested that DAS181 exhibited potent inhibitory activity against these Novel H1N1 viruses in these different models.

The related presentation, entitled "In Vivo and In Vitro Activity of DAS181 Against NAI-Resistant Influenza Virus" examined the in vivo and in vitro activity of DAS181 against patient isolates of community-acquired seasonal influenza from the 2008-2009 influenza season. All isolates had the H274Y mutation associated with resistance to Tamiflu. DAS181 in vitro was an effective inhibitor of Tamiflu-resistant influenza virus. In addition, in vivo mouse challenge studies with another NAI-resistant strain demonstrated strong sensitivity to DAS181 treatment.

Both studies are presented by Ronald Moss M.D., Executive Vice President, Clinical Development and Medical Affairs. "Based on these encouraging data we are moving forward with our ongoing clinical development of DAS181, and we will continue to work closely with FDA, CDC, and NIH on this clinical program during the current pandemic," stated Dr. Moss. "Because of viral evolution, alternatives to current treatment strategies are needed to deal with potential drug resistance. DAS181 may play an important role for public health preparedness during influenza pandemics."

ABOUT NEXBIO

NexBio, Inc. is a privately held clinical-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 and treating infection by influenza, including potential pandemic strains, and by parainfluenza viruses (which may cause serious respiratory illness similar to influenza and for which there is no approved vaccine or therapeutic). The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, under BAA Contract HHSN266200600015C and grant U01-AI070281. ViradinTM, invented and developed by NexBio, is a parenteral protein under development, currently at lead optimization stage, directed to the treatment of viral hemorrhagic fevers and bacterial biothreat sepsis. TOSAPTM is a technology invented and developed by NexBio and is used to formulate DAS181 for inhalation, as well as to make nano/microparticles from virtually any type of molecule. TOSAPTM is offered for the formulation of compounds of partners, under license.

For more information about NexBio, Inc., please visit http://www.nexbio.com

* FDA has yet to approve the name Fludase.

DISCLOSURE NOTICE:

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.


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