QUEBEC CITY, Feb. 1 /CNW/ - Medicago Inc. (TSX: 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.
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