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Last updated on April 23, 2014 at 20:01 EDT

Medicago receives FDA regulatory clearance to initiate U.S. clinical trial for a new influenza vaccine candidate

February 8, 2011

-The Company launches the clinical development of its seasonal flu
vaccine-

QUEBEC CITY, Feb. 8 /PRNewswire-FirstCall/ – 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 announced it has received Food and Drug
Administration (“FDA”) clearance for its phase I H1N1 influenza VLP
vaccine candidate (“H1N1 vaccine”) clinical trial in the United States.
The Company plans to initiate this trial within the coming weeks. This
phase I trial will lead into Medicago’s U.S. phase IIa trial for its
seasonal trivalent vaccine with the recommended H1N1, H3N2 and B
influenza strains which the Company plans to conduct later in 2011.

“Securing FDA approval to conduct this U.S. trial is a significant
milestone in the advancement of our seasonal influenza vaccine,” said

Andy Sheldon, President and CEO of Medicago. “Our recent positive phase
II interim results for our avian influenza vaccine have demonstrated to
date the safety and immunogenicity of our vaccine manufacturing
platform and provide us solid support for the development of our
seasonal vaccine candidate. In addition, our ability to rapidly and
cost-effectively produce quality vaccines is a key advantage over
traditional methods and will allow us to participate in the $2.8
billion
seasonal market which is expected to grow to $6.3 billion by
2019.”

The Phase 1, randomized, double-blind, multicenter, active- and
placebo-controlled dose-ranging study will evaluate the safety,
tolerability and immunogenicity of a single non-adjuvanted dose of the
H1N1 vaccine in 100 healthy adults 18-49 years of age. The subjects
will be randomized to receive one of the following; an injection of the
placebo, Medicago’s H1N1 vaccine or an H1N1 vaccine from a licensed
trivalent vaccine. The primary safety and immunogenicity results are
expected within 3 months of the start of this study. These data will
support the development of the Company’s seasonal influenza VLP vaccine
in the United States.

“Looking ahead, 2011 should prove to be an eventful year. We plan to
have completed a phase II trial for our H5N1 vaccine, completed a U.S.
phase I trial for our H1N1 vaccine, begun a U.S. phase IIa trial for
seasonal vaccine and have a fully operational U.S. commercial grade
vaccine production facility which will have the capacity to produce
more than 40 million seasonal vaccine doses per year,” added Mr.
Sheldon.

About Seasonal Influenza

Influenza is a contagious respiratory illness that can cause mild to
severe illness, and at times can lead to death. The Centers for Disease
Control and Prevention (“CDC”) states that the best way to prevent
seasonal flu is by getting a seasonal flu vaccination each year.
According to CDC, each year in the United States on average, 5% to 20%
of the population gets the flu; on average, more than 200,000 people
are hospitalized from flu-related complications, and; about 36,000
people die from flu-related causes. Some people, such as elderly
people, young children, and people with certain health conditions, are
at high risk for serious flu complications. According to Datamonitor,
global market projections of seasonal influenza are expected to
increase from $2.8 billion in 2008/2009 to $6.3 billion in 2018/2019.

About Medicago

Medicago is a clinical-stage biotechnology company, developing effective
and competitive vaccines based on proprietary Virus-Like Particles
(VLP) and manufacturing technologies. Medicago is developing VLP
vaccines to protect against pandemic and seasonal 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 the genetic sequence. 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.

SOURCE Medicago Inc.


Source: newswire