Medicago's H5N1 pandemic flu vaccine effective in key ferret animal model with single dose



    QUEBEC CITY, June 3 /CNW/ - Medicago Inc. (TSX-V: MDG) today announced
positive results from a preclinical immunogenicity study of the Company's H5N1
Avian Influenza VLP vaccine that was performed in ferrets, the most predictive
animal model for the effectiveness of influenza vaccines in humans. Results
demonstrated that a single 5-microgram dose of the Company's H5N1 VLP vaccine
induced high levels of antibodies in 100% of ferrets and met all required
immunogenicity criteria of the European Union Committee for Medicinal Products
for Human Use (CHMP). These criteria set by the CHMP for the approval of
seasonal flu vaccines in the European Union are widely used to assess immune
responses of new pandemic influenza vaccines in humans. In the case of
ferrets, these criteria are useful to predict effective doses that should be
tested in humans.
    "We believe these results are highly convincing as we prepare to commence
human clinical trials for our vaccine," said Andy Sheldon, President and CEO
of Medicago. "Our VLP vaccine is one of the first pandemic influenza vaccines
to demonstrate it may provide significant immune protection after a single
dose."
    "Ferrets are the gold standard for determining the immunogenicity and
efficacy of a vaccine candidate prior to human clinical trials," said
Nathalie Landry, Medicago's VP Product Development. "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. If these ferrets' results
replicate in human clinical trials, we believe that our vaccine will have the
potential to generate protection levels after just one dose of vaccine."
    The objective of Medicago's study was to determine the optimal dosage of
its VLP vaccine in ferrets. At the start of the study, ferrets were vaccinated
with a range of doses of the Company's VLP vaccine made from an Indonesian
strain of H5N1 Avian Influenza. A booster immunization was administered after
three weeks. The results demonstrated that ferrets vaccinated with doses
ranging from 5 to 15 micrograms met all CHMP criteria after the first dose
with 100% of the ferrets having an hemagglutination inhibition (HAI) titer
greater than 1:40. In addition, all ferrets vaccinated with lower doses of
1 (micro)g met the three CHMP criteria after two doses.

    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 press release contains forward-looking statements which reflect
Medicago's current expectations regarding future events. The forward-looking
statements involve risks and uncertainties. Actual results could differ
materially from those projected herein. Medicago disclaims any obligation to
update these forward-looking statements.

    The TSX Venture Exchange assumes no responsibility for the content or
    accuracy of this press release

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For further information:

For further information: Medicago, Inc., Andy Sheldon, President and
CEO, (418) 658-9393; Investor relations: The Equicom Group Inc., Arianna
Vanin, (514) 844-4680, avanin@equicomgroup.com

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