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Juvaris BioTherapeutics Announces Effectiveness
of the JuvImmune Immunostimulant
for AntiViral Applications
Juvaris Immunostimulant Demonstrates Complete
Efficacy for PuntaToro Virus Infection in a Prophylactic and Therapeutic
Rodent Model
Pleasanton, CA - April 12, 2005
Juvaris BioTherapeutics, Inc. announced today the completion of
the initial preclinical evaluation for the efficacy of the JuvImmuneTM
immunostimulant platform in a mouse model of PuntaToro virus infection.
This research was conducted at the Institute for Antiviral Research
of Utah State University and funded by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National Institutes
of Health.
PuntaToro virus (PTV), which produces a fatal hepatic disease in
animals, is closely related to the African and Middle Eastern Rift
Valley Fever and Sandfly Fever viruses. These viral infections have
had devastating effects in many parts of the world and are now considered
significant biodefense concerns to the United States. Results of
these studies were presented last week at the Federation of American
Societies for Experimental Biology (FASEB) meeting in San Diego,
California.
Juvaris' JuvImmuneTM technology was found to be highly active against
PTV infection and exhibited rapid activation of the innate immune
response for the production of anti-viral interferons as well as
interleukins. JuvImmuneTM treatment was well-tolerated and demonstrated
complete protection in both prophylactic and therapeutic applications.
Other observations included increased survival time, reduction of
virus-induced liver damage, and decreased virus titers.
Innate immune activation is the first-line of defense against viral
agents and is critical for induction of subsequent specific immune
responses. Preclinical studies, using JuvImmuneTM in other viral
and bacterial infection models, have also demonstrated substantial
amplification of immune responses and protection. JuvImmuneTM testing
is now being extended for evaluation in additional viral studies
including Respiratory Syncytial Virus (RSV) and Hepatitis B virus
(HBV).
"We are pleased with these dramatic efficacy results and the external
validation they provide for the JuvImmuneTM technology. We believe
our platform has significant broad-based product applicability in
both chronic and acute viral infections, including biodefense pathogens"
said Martin D. Cleary, Co-founder, Chairman and CEO of Juvaris.
About Juvaris
Juvaris BioTherapeutics was created in 2002 to develop an immunotherapeutic
product platform for the treatment of infectious diseases and cancer
using lipid-DNA complexes. Cationic lipids are formulated with non-coding
DNA (plasmid) to create JuvImmuneTM, a single lipid-DNA complex,
which as an immunostimulation product will have utility in a number
of non-antigen immunotherapeutic applications. The DNA in these
complexes does not code for protein, but rather, through a combined
synergistic effect with lipids, strongly stimulates immune responses.
The JuvImmuneTM product has been shown to be at least 50-times more
potent at triggering innate immune activation and interferon release
than current immune stimulants. Juvaris was recently issued Patent
No. 6,693,086 titled "Systemic Immune Activation Method Using Nucleic
Acid-Lipid Complexes" providing broad intellectual property coverage
for the JuvImmuneTM technology.
When combined with disease-specific antigens, the technology creates
JuvaVaxTM vaccines capable of activating substantial antibody- and
cell-mediated immune responses, particularly induction of cytotoxic
T lymphocytes. Immunological responses elicited by the lipid-DNA
complexes have been successfully demonstrated in both prophylactic
and therapeutic settings in a variety of mammals including rodents,
rabbits, cats, dogs and non-human primates. Moreover, substantial
immune responses have been induced following oral administration.
This system provides the opportunity to develop many disease-specific
vaccine products, for which there are significant unmet medical
needs.
Over the past nine months, the Company has announced collaborations
or investigational studies with Cell Genesys, SomaGenics, the University
of California-San Francisco, Penn State University, the Defense
Advanced Research Projects Agency (DARPA), the National Institutes
of Health (NIH), the Institute for Antiviral Research at Utah State
University, and the International AIDS Vaccine Initiative (IAVI).
The Company encourages investment and partnering inquiries and
can be reached at its website @ www.juvaris.com. Company Contact:
Grant E. Pickering
Juvaris BioTherapeutics, Inc.
863A Mitten Road
Burlingame, California
650-259-1800 ext. 227
gpickering@juvaris.com
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