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Medicago Reports Positive Phase I Results for its Avian Flu Pandemic Vaccine

Geschrieben am 21-12-2009

Quebec City (ots/PRNewswire) - Medicago Inc. 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
http://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.

For further information: Medicago, Inc., Andy Sheldon, President
and CEO, +1-418-658-9393 x135; Medicago Inc., Pierre Labbe, Chief
Financial Officer, +1-418-658-9393 x135

ots Originaltext: Medicago
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: For further information: Medicago, Inc., Andy Sheldon,
Presidentand CEO, +1-418-658-9393 x135; Medicago Inc., Pierre Labbe,
Chief FinancialOfficer, +1-418-658-9393 x135


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