NexBio Publishes Two Articles Showing DAS181 (Fludase) 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
Source: NexBio, Inc.
CONTACT: David Wurtman, M.D., M.B.A, VP, Corporate Development
of
NexBio, Inc., +1-858-452-2631, dwurtman@nexbio.com
Web Site: http://www.nexbio.com/
Posted: November 2009
