QUEBEC CITY , Nov. 1 /CNW/ - Medicago Inc. (TSX: MDG) a biotechnology
company focused on developing highly effective and affordable vaccines
based on proprietary manufacturing technologies and Virus-Like
Particles (VLPs), today announced that it has received clearance from
Health Canada to commence a Phase II human clinical trial with its H5N1
Avian Influenza vaccine ("H5N1 vaccine"). Enrolment of volunteers is
now underway.
The Phase II randomized, placebo controlled clinical trial will evaluate
the safety and immunogenicity of different doses of its H5N1 vaccine.
Specifically, the vaccine will be studied in approximately 255 healthy
adults between the ages of 18 to 60 years. In the first part of the
study healthy adults will receive an injection of either a placebo or
the H5N1 vaccine at varying doses to determine the optimal dose. In the
second part of the study, healthy adults will receive an injection of
either a placebo or the H5N1 vaccine at the optimal dose.
Interim-results of this study are expected in less than three months.
"The initiation of our Phase II clinical trial is an important step in
the development of our plant-based VLP vaccines, which we believe are
highly effective, cross-protective, less expensive and faster to
produce than current influenza vaccines. It also demonstrates our
ability to advance candidates through clinical development," said Andy
Sheldon, President and CEO of Medicago. "Our platform is very versatile
and to date, we have been able to produce a broad array of other
proteins with potential use in the life science industry. This clinical
trial therefore provides additional validation for our rapid and
cost-effective technology platform offering."
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
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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