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