-Presentation of Positive Interim Phase I Clinical Trial results for an
H5N1 Vaccine with GLA Adjuvant-
QUEBEC CITY, and SEATTLE, WA, April 9, 2013 /CNW Telbec/ - Medicago Inc. (TSX: MDG); (OTCQX: MDCGF), a biopharmaceutical company
focused on developing highly effective and competitive vaccines based
on proprietary manufacturing technologies and Virus-Like Particles
(VLPs) and, IDRI (Infectious Disease Research Institute), a
Seattle-based non-profit research organization that is a leading
developer of adjuvants used in vaccines combating infectious disease,
today announced that they will be presenting positive interim Phase I
clinical results for their H5N1 Avian Influenza VLP vaccine candidate
"H5N1 vaccine" at the World Vaccine Congress. The meeting is being held
at the Gaylord National Hotel and Convention Center in Washington, DC,
April 16-18, 2013.
Dr. Steven Reed, Founder, President, & Chief Scientific Officer, IDRI,
and Dr. Brian Ward, Professor of Medicine & Microbiology, McGill
University, member of Medicago's scientific advisory committee, will be
presenting at the World Vaccine Congress on April 17, 2013, at 2:35
p.m. EST. The presentation, titled "H5N1 Phase 1 clinical trial
combining Medicago's VLP vaccine with IDRI's GLA adjuvant formulation,"
will discuss preliminary safety and immunology data from the ongoing
H5N1 vaccine clinical trial.
The Phase I clinical trial, which commenced in September 2012, enrolled
100 healthy adult volunteers, aged 18-49 years, at three locations in
the U.S., testing for safety and immune response. The vaccine was also
tested in comparison to Medicago's H5N1 vaccine with alum. The trial is
funded by a multi-million dollar grant IDRI received from the Defense
Advanced Research Projects Agency (DARPA), a division of the United
States Department of Defense, to investigate the safety and
immunogenicity of a novel adjuvant with a Nicotiana benthamiana produced vaccine candidate. Each study participant in the trial received
two doses of a given formulation in order to collect and compare data.
The trial focused on evaluating the safety and immunogenicity of the
H5N1 vaccine, combined with IDRI's Glucopyranosyl Lipid A ("GLA")
adjuvant, which was administered intramuscularly or intradermally. The
intradermal route of administration was also tested in comparison with
intramuscular delivery, using an FDA licensed device (MicronJet600®,
NanoPass Technologies) as the micro-needle device was previously shown
in seasonal and pandemic flu tests to allow significant dose sparing.
This study is among the first to test intradermal adjuvants.
"This trial is an important step toward development of an influenza
vaccine that could be rapidly and widely administered in case of a
pandemic outbreak," said Reed.
According to the Centers for Disease Control and Prevention, the highly
pathogenic avian influenza A (H5N1) virus is a deadly virus that occurs
mainly in birds including domestic poultry. Though relatively rare,
sporadic human infections with this virus have occurred and caused
serious illness and death. Because of the unpredictability of pandemic
flu, efforts are being made to create and stockpile a vaccine to combat
H5N1 that reduces the amount of vaccine needed per person and can be
easily administered.
The H5N1 vaccine candidate includes IDRI's GLA adjuvant, which has been
exclusively licensed to Immune Design Corp. for certain fields,
including influenza, and is produced in Medicago's plant-based
expression system, which is speedier than the traditional route of
producing flu vaccines in eggs. The adjuvant system has been combined
with Medicago's vaccine candidate and other recombinant protein
antigens to elicit both humoral and cell-mediated immune responses
associated with protection in pathogenic animal challenge models. In
animal studies, GLA has also been shown to expand the cross reactivity
of antibodies induced by the H5N1 vaccine to other potential pandemic
influenza strains such as H2N2.
About IDRI
As a nonprofit global health organization, IDRI (Infectious Disease
Research Institute) takes a comprehensive approach to combat infectious
diseases, combining the high-quality science of a research organization
with the product development capabilities of a biotech company to
create new diagnostics, drugs and vaccines. IDRI combines passion for
improving human health with the understanding that it is not just what
our scientists know about disease, but what we do to change its course
that will have the greatest impact. Founded in 1993, IDRI has 125
employees headquartered in Seattle with more than 50
partners/collaborators around the world. For more information, visit www.idri.org.
About Medicago
Medicago is a clinical-stage biopharmaceutical company developing novel
vaccines and therapeutic proteins to address a broad range of
infectious diseases worldwide. The Company is committed to providing
highly effective and competitive vaccines and therapeutic proteins
based on its proprietary VLP and manufacturing technologies. Medicago
is a worldwide leader in the development of VLP vaccines using a
transient expression system which produces recombinant vaccine antigens
in plants. This technology has potential to offer more potent vaccines
with speed and cost advantages over competitive technologies, enabling
the development of a vaccine for testing in approximately one month
after the identification and reception of genetic sequences from a
pandemic strain. This production time frame has the potential to allow
vaccination of the population before the first wave of a pandemic, and
supply large volumes of vaccine antigens to the world market. Medicago
also intends to expand development into other areas such as biosimilars
and biodefense products where the benefits of our technologies can make
a significant difference. Additional information about Medicago is
available at www.medicago.com.
About NanoPass Technologies Ltd.
NanoPass is the developer of MicronJet600™, an FDA-registered
intradermal microneedles device. NanoPass has concluded the world's
first intradermal pandemic (H1N1) flu vaccine clinical study and
additional seasonal flu studies, demonstrating equivalent or superior
immunogenicity to standard intramuscular delivery using only 20% of the
dose.
Forward Looking Statements
This news release includes certain forward-looking statements or
forward-looking information for the purposes of applicable securities
laws and such statements and information are based upon current
expectations, which involve risks and uncertainties associated with
Medicago's business and the environment in which the business operates.
Any statements contained herein that are not statements of historical
facts may be deemed to be forward-looking, including those identified
by the expressions "anticipate", "believe", "plan", "estimate",
"expect", "intend", and similar expressions to the extent they relate
to Medicago or its management. The forward-looking statements are not
historical facts, but reflect Medicago's current expectations regarding
future results or events. Such statements include but are not limited
to statements about the collaboration with IDRI and the Phase I
clinical trial. These forward-looking statements are subject to a
number of risks and uncertainties that could cause actual results or
events to differ materially from current expectations, including the
matters discussed under "Risk Factors and Uncertainties" in Medicago's
Annual Information Form filed on March 28, 2013, with the regulatory
authorities. Medicago assumes no obligation to update the
forward-looking statements, or to update the reasons why actual results
could differ from those reflected in the forward-looking statements.
SOURCE: Medicago Inc.
