NexBio(R) Publishes Two Articles Showing DAS181 (Fludase(R)*) Potently Inhibits Pandemic Influenza A(H1N1) and NAI-Resistant Influenza Viruses

SAN DIEGO, Nov. 6 /PRNewswire/ -- NexBio Inc., in collaboration with scientists at the Centers for Disease Control and Prevention (CDC), St. Louis University, and the University of Hong Kong, announced today the publication of two articles in the peer-reviewed journal PLoS ONE. These two published studies suggest that DAS181 (Fludase®) may play a potentially important role for the treatment and prevention of the Pandemic Influenza A(H1N1) and drug-resistant influenza.

DAS181 is a broad spectrum drug candidate being studied in human clinical trials for treatment and prevention of Influenza-Like Illness (ILI) caused by any strain of influenza and parainfluenza viruses. Unlike neuraminidase inhibitors (NAI), e.g. Tamiflu® (oseltamivir), as well as vaccines, which target the influenza virus ("pathogen target"), DAS181 works by inactivating the human receptors ("host target") for these viruses; thus, it may be less likely to cause drug resistance compared with currently-available antiviral drugs.

One published paper entitled "Novel Pandemic Influenza A(H1N1) Viruses are Potently Inhibited by DAS181, a Sialidase Fusion Protein" evaluated the antiviral activity of DAS181 against multiple Pandemic Influenza A(H1N1) viral clinical isolates in a number of preclinical models. DAS181 inhibited all of the pandemic viral strains in each study model. It demonstrates significant antiviral activity against the H1N1 viruses in primary human respiratory cells as well as in fresh human bronchial tissue. In studies performed at the CDC, DAS181 treatment given after infection by a Pandemic Influenza A(H1N1) virus completely prevented animal death. It also successfully prevented viral replication and weight loss in these animals.

In the second published paper entitled "Inhibition of Neuraminidase Inhibitor-Resistant Influenza Virus by DAS181, a Novel Sialidase Fusion Protein", the activity of DAS181 against clinical isolates of seasonal H1N1 influenza virus collected from influenza patients during 2004, 2007, and 2009 was studied. The isolates from 2007 and 2009 are all resistant to Tamiflu® as all contain the H274Y mutation known to cause such resistance. Notably, all isolates were strongly inhibited by DAS181. Additionally, NexBio has data to demonstrate that a laboratory strain of influenza which is resistant to all three NAIs (oseltamivir, zanamivir, peramivir) in vitro was inhibited by DAS181 in cell culture and in animals in the study.

"These results are particularly important because of the current H1N1 pandemic and the urgent need for new antiviral drugs with different approaches from currently available NAIs. Neuraminidase inhibitor drug resistance is already a significant problem for seasonal influenza. Tamiflu® drug resistance caused by the same mutation in Pandemic Influenza A(H1N1) is now being seen worldwide" commented Dr. Fang Fang, NexBio's President of Research & Development. "Unique among licensed influenza drugs and those in clinical development, DAS181 uses a Host-Oriented Therapeutic (HOT) strategy. Our goal for the continued advanced clinical development of DAS181 is to bring a potentially important new medicine to the treatment and prevention of this worldwide problem," Dr. Fang added

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 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. 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. TOSAP® 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. TOSAP® 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.

    Contact:

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