GeneOne Life Science Inc. (KSE:011000) today announced that
enrollment has been completed of the first-in-human clinical trial
of the GLS-5300 vaccine for MERS (Middle East Respiratory Syndrome)
with a total of 75 subjects. GeneOne Life Science and U.S.-based
Inovio Pharmaceuticals (NASDAQ:INO) are co-developing the
vaccine. This phase I clinical trial is funded by the Walter
Reed Army Institute of Research (WRAIR) and is being conducted at
its Clinical Trials Center in Silver Spring, Md.
The MERS vaccine (GLS-5300) was designed as a SynCon® vaccine by
Inovio and was manufactured by VGXI, Inc., which is GeneOne’s
wholly owned subsidiary and located in the Woodlands, Texas.
Middle East Respiratory Syndrome is caused by a coronavirus that
is related to the severe acute respiratory syndrome (SARS) virus
that over 10 years ago infected more than 8,000 people, with a 10%
death rate. There is no vaccine or effective treatment against
MERS, which spreads from human to human. Since 2012, MERS has
infected almost 1,500 people and killed about 600 (40%). In the
summer of 2015, South Korea was the site for the largest outbreak
outside of Saudi Arabia of this emergent global health concern with
186 people infected with 36 (20%) fatalities.
Mr. Young K. Park, CEO, GeneOne Life Science, said, “MERS cases
are continuing in the Middle East and we are moving rapidly with
our partners to test a MERS vaccine in the clinic because there is
no vaccine or treatment for this virulent virus. The completion of
enrollment is a major step forward in combatting a highly lethal
infection that has triggered widespread outbreaks in the Middle
East and Korea.
About Inovio Pharmaceuticals, Inc.
Inovio is taking immunotherapy to the next level in the fight
against cancer and infectious diseases. We are the only
immunotherapy company that has reported generating T cells in vivo
in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and Laval University. For more
information, visit www.inovio.com.
About the Walter Reed Army Institute of
Research
Headquartered in Silver Spring, Maryland, the Walter Reed Army
Institute of Research (WRAIR) is the oldest and most diverse
biomedical research laboratory in the Department of Defense. WRAIR
provides unique research capabilities and innovative solutions to a
range of force health and readiness challenges currently facing
U.S. Service Members, along with threats anticipated during future
operations. Emerging infectious diseases such as MERS pose an
ongoing threat to military operations and readiness. WRAIR develops
vaccines, drugs and diagnostics for these diseases of importance to
military and public health. For more information on WRAIR,
visit http://wrair-www.army.mil/
About VGXI, Inc.
With over 15 years of experience, VGXI, Inc. is a leading
provider of plasmid DNA manufacturing and development services for
DNA vaccine and gene therapy research. The company has an
outstanding track record of success in manufacturing plasmid
products under cGMP conditions for clinical trials in the US, EU,
Asia and Australia, and its cGMP and non-GMP products have passed
rigorous reviews by several international regulatory agencies.
VGXI’s ability to work with unique requirements and create custom
manufacturing solutions is based on its patented manufacturing
process, flexible cGMP production facility, and experienced
development team. VGXI, Inc. is a wholly-owned subsidiary CMO of
GeneOne Life Science, Inc. To learn more about VGXI's services,
visit http://www.vgxii.com/about.
About GeneOne Life Science
GeneOne Life Science Inc. is an international DNA vaccine
developer and leading contract manufacturer of DNA plasmid-based
agents for pre-clinical and clinical trials for global companies
and institutions. It researches and develops DNA vaccines to
prevent and treat incurable diseases in South Korea and
internationally. The company is headquartered in Seoul, South
Korea. VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary
located in Texas, is the largest pure-play cGMP DNA plasmid
manufacturing facility in the world. For more information, visit
www.genels.com.
Cautionary Factors That May Affect Future
Results
Materials in this press release contain information that
includes or is based upon forward-looking statements within the
meaning of the Securities Litigation Reform Act of 1995.
Forward-looking statements relate to expectations or forecasts of
future events. These statements can be identified by the fact that
they do not relate strictly to historical or current facts. They
include words such as “anticipate,” “estimate,” “expect,”
“project,” “intend,” “plan,” “believe,” and other words and terms
of similar meaning in connection with a discussion of potential
future events, circumstances or future operating or financial
performance. In particular, these include statements relating to
future actions, prospective products or product approvals, future
performance or results of current and anticipated products, sales
efforts, expenses, the outcome of contingencies such as legal
proceedings, and financial results. Any or all of our
forward-looking statements here or in other publications may turn
out to be incorrect. They can be affected by inaccurate assumptions
or by known or unknown risks and uncertainties. Many such factors
will be important in determining our actual future results.
Consequently, no forward-looking statement can be guaranteed, and
forward-looking statements may be adversely affected by factors,
including general market conditions, competitive product
development, product availability, current and future branded and
generic competition, federal and state regulations and legislation,
manufacturing issues, timing of the elimination of trade buying,
patent positions, litigations and investigations. Our actual
results may vary materially, and there are no guarantees about the
performance or valuation of GeneOne stock. It is also important to
read the disclosure notice contained in many of the individual
GeneOne documents available on the GeneOne Web site as many contain
important information on such cautionary factors as of the date of
the individual document. We undertake no obligation to correct or
update any forward-looking statements, whether as a result of new
information, future events or otherwise. You are advised, however,
to consult any further disclosures we make on related subjects in
our reports.
Media inquiries:
J.C. Richardson
267-440-4211
jeff@richardsonglobalpr.com
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