NexBio and Weill Cornell Medical College Publish Preclinical Study Showing DAS181 (Fludase) Anti-Influenza Drug Inhibits Parainfluenza Virus
SAN DIEGO, June 18 /PRNewswire/ -- NexBio, Inc. announced today
the publication of a "Major Article" in the Journal of Infectious
Diseases of a preclinical study showing that treatment with DAS181
(Fludase®) inhibits infection with multiple human parainfluenza
virus (HPIV) strains. DAS181 is a broad spectrum host-targeted
investigational drug candidate for treatment and prevention of
Influenza-Like Illness (ILI). Earlier publications have shown
DAS181's preclinical activity against numerous strains of influenza
(IFV) including Pandemic Influenza A(H1N1) and highly pathogenic
avian H5N1.
Parainfluenza viruses are a common and underappreciated cause of
respiratory viral infection in people of all ages and a potentially
lethal infection in individuals with weakened immune systems and
other underlying illnesses. There is currently no approved drug or
vaccine for any HPIV strain. Both HPIV and IFV gain entry to human
respiratory epithelial cells by attaching to sialic acid receptors.
DAS181 works by inactivating these receptors, thereby preventing or
containing infection. As it is difficult to distinguish clinically
between infection with IFV and HPIV, a broad-spectrum respiratory
antiviral agent that treats all IFVs and HPIVs equally well would
be highly desirable in the clinical setting.
In the paper entitled "A Recombinant Sialidase Fusion Protein
Effectively Inhibits Human Parainfluenza Viral Infection In Vitro
and In Vivo" studies were conducted using DAS181 with HPIV1, HPIV2
and HPIV3 strains, both in cell-based systems and in cotton rats.
DAS181 was shown to significantly curtail HPIV infection and to do
so as efficiently as for inhibiting IFV.
"Therapies for parainfluenza are urgently needed. Development of
effective antiviral drugs and vaccines for HPIV has lagged far
behind IFV, despite the recognized impact of these diseases in
children and the more recently recognized importance of these
pathogens in the adult population, particularly the elderly,
immunocompromised, and patients with underlying airway disease,"
commented Dr. Anne Moscona, Professor of Pediatrics and of
Microbiology and Immunology, Vice Chair for Research of Pediatrics,
and Chief of Pediatric Infectious Diseases at Weill Cornell Medical
College, and co-corresponding author of the paper with Dr. Fang
Fang, NexBio's President of R&D. "DAS181, if shown effective in
clinical studies, could be a promising treatment for HPIV," Dr.
Moscona added.
Earlier publications have described DAS181's activity for
Pandemic Influenza A(H1N1) and highly pathogenic avian H5N1, as
well as for IFV resistant to neuraminidase inhibitors (NAIs) such
as Tamiflu® (oseltamivir). Unlike NAIs or vaccines, which both
target the virus ("pathogen target"), DAS181 works by inactivating
the human receptors ("host target") to which viruses bind; thus,
drug resistance may be less likely to emerge compared with
currently-available antiviral drugs. In addition, NexBio has
recently presented data from three independent studies in animal
models of asthma, done with academic collaborators, demonstrating
DAS181's potential benefit for airway diseases.
DAS181 is currently being studied for influenza in a human phase
II clinical trial funded by the National Institute of Allergy and
Infectious Diseases (NIAID, part of the National Institutes of
Health, NIH) and monitored by an independent Data Safety Monitoring
Board. This investigational drug is also being studied in patients
with the respiratory conditions asthma and bronchiectasis in a
trial conducted by NIAID at the NIH Clinical Center. This latter
trial examines the effects of DAS181 in subjects with
well-controlled or stable pulmonary disease. More information is
available at www.clinicaltrials.gov.
The work at Weill Cornell was supported by a Public Health
Service grant from the National Institutes of Health (NIAID) to
Anne Moscona, a March of Dimes Research Grant to Anne Moscona, and
an American Lung Association Research grant to Matteo
Porotto.
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 undergoing phase II
clinical development, directed to the treatment and prophylaxis of
influenza-like illness caused by any and all strains of influenza,
including pandemic strains, and parainfluenza. DAS181 is a
host-targeted inhaled recombinant fusion protein that inactivates
viral receptors on the cells of the human respiratory tract,
thereby treating and preventing viral infection. 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. Sepcidin(TM), invented and developed by NexBio, is a
parenteral protein at lead optimization stage, directed to the
treatment of viral hemorrhagic fevers, bacterial biothreat agents
and sepsis. 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 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/.
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 * 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.
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: June 2010
