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NexBio Presents Data at ACAAI 2010 Demonstrating Mechanism of Action for Improvement in Airway Function by DAS181 (Fludase®*)
Date:11/11/2010

SAN DIEGO, Nov. 11, 2010 /PRNewswire/ -- NexBio, Inc. announced the presentation of new data at the 2010 annual American College of Allergy, Asthma, and Immunology in Phoenix, Arizona.  The presentation was entitled "DAS181 (Fludase®), a Sialidase, Decreases Airway Resistance by Modulating Muscarinic Receptor Signaling."

DAS181 (Fludase®) is an investigational broad spectrum host-targeting antiviral drug candidate undergoing clinical development for the treatment and prevention of Influenza-Like Illness caused by all strains of influenza and parainfluenza (PIV).  These new data show that, independent of its antiviral activity, and by a different mechanism of action, DAS181 may have benefit for airway diseases such as asthma and COPD.

NexBio presented nonclinical data at ACAAI 2009 from studies in three animal models of asthma, demonstrating that DAS181 inhibits airway hyperreactivity characteristic of asthma, as well as airway inflammatory cells and airway mucus, characteristic of chronic airway inflammatory conditions such as COPD.  The current presentation at 2010 ACAAI builds on this prior work by elucidating a key mechanism of action.  The data demonstrate that desialylation of airway muscarinic receptors in both in vivo and in vitro models unexpectedly reduces muscarinic pathway signaling. DAS181 given to mice once daily for three days, at doses lower than those used for antiviral treatment, leads to significantly reduced airway resistance in response to challenge by methacholine.

"The data suggest that DAS181 may have a dual benefit for patients with airway disease who become infected with the respiratory viruses influenza and parainfluenza, as DAS181 may fight infection while simultaneously controlling the underlying airway disease.  These patients are at high risk for exacerbations of their airway disease, as was seen during the 2009 Pandemic, and it is possible that DAS181 may limit or prevent complications," said Dr. Ron Moss, NexBio's Executive Vice President of Clinical Development and Medical Affairs, and presenter of the data.  "These new data also suggest that DAS181 might be useful as a novel, once-daily anti-muscarinic agent for the management of patients with diseases such as asthma and COPD, and an ongoing clinical trial is assessing this possibility," added Dr. Moss.  

DAS181 is an investigational drug currently in an ongoing Phase 2 clinical trial of subjects infected with influenza. NexBio has previously announced the publication of several articles in peer-reviewed journals describing non-clinical activity of DAS181 for Pandemic Influenza A(H1N1), neuraminidase inhibitor (NAI)-resistant influenza, avian H5N1, and, PIV strains, in ex vivo, in vivo and in vitro models. As well, a Phase 1/2 study of the safety and activity of DAS181 for (uninfected) patients with asthma and bronchiectasis is ongoing at the Clinical Center at the National Institutes of Health.  

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®) is an investigational drug in Phase 2 that consists of an inhaled recombinant fusion protein.  It 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. SepcidinTM, invented and developed by NexBio, is a parenteral protein at pre-clinical lead optimization stage, directed to the treatment of sepsis/SIRS, viral hemorrhagic fevers, bacterial biothreat agents.  TOSAP®, a technology invented and developed by NexBio, is used to formulate DAS181 for inhalation, as well as to make microparticles from virtually any type of large and small molecule, and combinations of molecules. TOSAP is offered for the formulation of compounds of partners, under license.

For more information about NexBio, Inc., please visit http://www.nexbio.comContact:David Wurtman, M.D., M.B.A.VP, Corporate Development5 Sorrento Valley RoadSan Diego, CA  92121Phone: (858) 452-2631dwurtman@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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SOURCE NexBio, Inc.
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