- Company's results continue to be amongst the
best for influenza vaccine manufacturing technologies -
-Company's VLP induced the production of antibodies that cross
react with multiple strains of influenza-
QUEBEC CITY, Feb. 1
/PRNewswire-FirstCall/ - Medicago Inc. (TSX-V: MDG) a biotechnology
company focused on developing highly effective and competitive
vaccines based on proprietary manufacturing technologies and
Virus-Like Particles (VLPs), today reported positive interim
results from a Phase II human clinical trial with its H5N1 Avian
Influenza VLP vaccine candidate ("H5N1 vaccine"). The vaccine was
found to be safe, well tolerated and also induced a solid immune
response.
"We believe our phase II interim study results continue to show
impressive findings. These data demonstrate that our H5N1 vaccine
is both safe and introduces cross-reactive antibody responses
against multiple strains of H5N1," said Andy Sheldon, President and CEO of Medicago. "We
also believe that our effective VLP vaccine, produced in less than
one month, is capable of providing a rapid response to an influenza
pandemic, a much needed solution. With these encouraging results in
hand, we will proceed with part B of our Phase II study and look
forward to reporting final data in Q2 2011."
"These results demonstrate that we have a safe
product, as our H5N1 vaccine was well tolerated at all levels,"
said Nathalie Landry, VP Product
Development of Medicago. "We are the first novel vaccine
manufacturing technology to report an immune response of this kind
at such low dosage levels. This is especially important as H5N1
vaccines are known to be poorly immunogenic in humans. The results
indicate that we have a solid vaccine manufacturing platform and we
look forward to continuing the clinical advancement of our vaccine
candidates."
"These very promising results clearly indicate
the potential of Medicago's innovative proprietary plant-based VLP
vaccine technology," said Doug Dean,
Senior Vice President R&D of Philip Morris International (PMI).
PMI currently holds 33% of Medicago's outstanding shares.
Interim results of the study
The study enrolled 135 healthy volunteers who were immunized with
Medicago's vaccine at 3 dosage levels to determine the optimal
dose. No serious adverse events were reported during the trial and
the vaccine was found to be safe and well tolerated at all levels.
Local site reactions were mild and comparable between the H5N1
vaccine groups. In those vaccinated in the 18 to 49 age group at
the 20 microgram dosage level, 82% of immunized subjects developed
an immune response against the H5N1 virus after the second
immunization, 65% of subjects had a four-fold increase in HI titers
from baseline and 65% of subjects had seroprotective antibody
titers. All subjects tested negative for antibodies to the H5N1
A/Indonesia strain before
vaccination and no response was observed among individuals who
received a placebo. These data show that Medicago's H5N1 vaccine
induces a robust hemagglutination inhibition (HAI) antibody
response against the H5N1 vaccine strain. The H5N1 vaccine also
induced the production of antibodies that react with multiple
strains of H5N1 Avian Influenza indicating the potential for
cross-protection of Medicago's vaccines. As planned in the initial
design, adverse event monitoring will continue for six months after
administration of the second dose of vaccine.
Based on these results, a committee will be selecting the
optimal dose to proceed with Part B of the Phase II H5N1 vaccine
clinical trial. In the second part of the study, 120 healthy adults
will receive an injection of either the H5N1 vaccine at the optimal
dose or a placebo. Final results are currently expected in the
second quarter of 2011.
About Medicago's pandemic flu vaccine
candidate
Medicago's H5N1 vaccine candidate was formulated to protect against
the Indonesian influenza virus. It is manufactured in Nicotiana
benthamiana, a relative of the tobacco plant, using the
Company's proprietary VLP technology. VLPs may have several
advantages over traditional flu vaccines. They are made to look
like a virus, allowing them to be recognized readily by the body's
immune system, however, they lack the core genetic material making
them non-infectious and unable to replicate. Medicago's technology
only requires the genetic sequence of a viral strain and not the
live influenza virus. This key difference allows vaccines to be
manufactured within four weeks of obtaining the genetic sequence of
a pandemic strain. This is in contrast with current manufacturing
technologies which rely on strain adaptation and can only deliver a
vaccine six to nine months after a pandemic is declared.
About Medicago
Medicago is committed to provide highly effective and competitive
vaccines based on proprietary Virus-Like Particle (VLP) and
manufacturing technologies. Medicago is developing VLP vaccines to
protect against H5N1 pandemic influenza, using a transient
expression system which produces recombinant vaccine antigens in
non-transgenic plants. This technology has potential to offer
advantages of speed and cost over competitive technologies. It
could deliver a vaccine for testing in about a 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
strikes and to supply large volumes of vaccine antigens to the
world market. Additional information about Medicago is available at
www.medicago.com.
Forward Looking Statements
This news release includes certain forward-looking statements
that 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. 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 "Risks
Factors and Uncertainties" in Medicago's Annual Information Form
filed on March 24, 2010 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.
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