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Message: Medicago reports positive Phase I results for it's avian flu pandemic vaccine

Medicago reports positive Phase I results for it's avian flu pandemic vaccine

posted on Dec 21, 2009 07:30AM

MEDICAGO INC.

Attention Business Editors

Medicago reports positive Phase I results for its avian flu pandemic vaccine

	    - Company's results amongst the best for influenza vaccine manufacturing
technologies -

	    QUEBEC CITY, Dec. 21 /CNW/ - Medicago Inc. (TSX-V: MDG) a biotechnology
company focused on developing highly effective and affordable vaccines based
on proprietary manufacturing technologies and Virus-Like Particles (VLPs),
today reported positive interim results from a Phase I human clinical trial
with its H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine
was found to be safe, well tolerated and also induced a solid immune response.
	    "We are very pleased with the results from this study. This trial was the
first ever clinical evaluation of a plant-based Influenza VLP vaccine and
shows that Medicago's vaccine is safe in humans," said Andy Sheldon, President
and CEO of Medicago. "We believe our novel vaccine candidate, coupled with our
rapid response and low cost manufacturing system offers a preferred option to
increase the speed of a public health response in the event of a pandemic
outbreak. Looking ahead, the successful completion of this trial should enable
us to formalize various partner agreements. It may also allow us to access new
sources of non-dilutive funding available through U.S. grant programs and by
organizations interested in funding the development of better technologies for
pandemic vaccine production."
	    The Phase I study was designed to investigate the safety of the Company's
H5N1 alum-adjuvanted pandemic vaccine candidate and to provide an initial
indication of the immune response. A total of 48 healthy volunteers between
the ages 18 to 60 received two doses of either Medicago's vaccine at doses of
5, 10 or 20 micrograms (mcg) or a placebo. No serious adverse events were
reported during the trial and the vaccine was found to be well tolerated at
all three dose levels. Local site reactions were mild and the incidence of
systemic side effects was comparable between the H5N1 vaccine groups and the
placebo. As planned in the initial design, adverse event monitoring will
continue for six months after administration of the second vaccine dose. The
trial was conducted at the Vaccine Evaluation Center of McGill University in
Montreal, Canada, under the supervision of Dr. Brian Ward.
	    Preliminary results showed that 81% of immunized subjects developed an
immune response against the H5N1 virus after the second immunization. A
four-fold increase in HI titers from baseline in 58% of subjects was observed
in the 20 mcg group. HI titers greater than 1:40 were developed in 50% of the
subjects in the 20 mcg group. The H5N1 vaccine also induced the production of
antibodies cross-reacting with two other strains of H5N1 Avian Influenza
suggesting Medicago's vaccine potential for cross-protection.
	    "Results at these lower dosage levels have not been reported for an H5N1
vaccine manufactured with a novel vaccine manufacturing technology," said
Nathalie Landry, VP Product Development of Medicago. "H5N1 vaccines are poorly
immunogenic in humans and are known to require repeated administrations with
an adjuvant to elicit an immune response at low doses."
	    Full results of this trial will be submitted for publication in a
scientific journal and will be available in the coming months. Based on these
results, Medicago will proceed with a Phase II clinical trial, expected to
commence during the first half of 2010.

	    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. FDA-approved H5N1 influenza vaccines
in the United States require two 90-microgram doses, administered at least
four weeks apart to achieve appropriate level of antibodies in 44% of
vaccinated individuals. Because Medicago's technology requires the genetic
sequence of a viral strain and not the live influenza virus, vaccines can 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 affordable 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 Company
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 25, 2009 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.

	    Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release.






-30-
	    /For further information: Medicago, Inc., Andy Sheldon, President and
CEO, (418) 658-9393 x135; Medicago Inc., Pierre Labbé, Chief Financial
Officer, (418) 658-9393 x135/
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