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Last updated on April 19, 2014 at 1:20 EDT

Medicago reports positive U.S. clinical trial results for its H1N1 / seasonal influenza vaccine

June 8, 2011

- All tested doses were found safe and well-tolerated -

- A single dose of 5 µg met the 3 CHMP immunogenicity criteria -

QUEBEC CITY, June 8, 2011 /PRNewswire/ – 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 reported positive results from a
U.S. Phase I human clinical trial with its seasonal influenza vaccine
candidate (“H1N1 vaccine”). All vaccine doses were found to be safe,
well tolerated and also induced a solid immune response. Based on these
results and subject to regulatory approval, Medicago intends to proceed
with a U.S. Phase IIa trial for its seasonal trivalent vaccine with the
recommended H1N1, H3N2 and B influenza strains.

“These positive U.S. clinical trial results are an important milestone
as they continue to demonstrate that our rapid plant-based vaccine
technology is both safe and effective,” said Andy Sheldon, President
and CEO of Medicago. “Our VLP vaccine was well-tolerated at all dosage
levels. In addition, all dosage levels, including our lowest 5ug dose,
generated a robust immune response exceeding the CHMP (Committee for
Medicinal Products for Human use) immunogenicity criteria. These
remarkable results are a testament to the quality of our VLP vaccine
technology. We continue to believe our effective vaccine candidate,
coupled with our rapid response and low cost manufacturing system
offers unique advantages in the development of seasonal and pandemic
influenza vaccine candidates.”

Study Design

The U.S. Phase I study was designed to investigate the safety of the
Company’s H1N1 vaccine candidate and to provide an initial indication
of the immune response. A total of 100 healthy volunteers between the
ages 18 to 49 received one of the following; a single non-adjuvanted
dose of Medicago’s H1N1 vaccine at varying doses (5ug, 13ug, 28ug), an
injection of the placebo or an H1N1 vaccine from a licensed trivalent
vaccine.

Safety Results

No serious adverse events were reported during the trial and the vaccine
was found to be well tolerated at all three dosage levels. Local site
reactions were mild and the incidence of systemic side effects was
comparable between the H1N1 vaccine groups and the placebo. As planned
in the initial design, adverse event monitoring will continue for six
months.

Immunogenicity Results

A single non-adjuvanted injection of the H1N1 Influenza VLP vaccine at
doses of 5mg, 13mg, and 28mg induced immune responses against the H1N1
viral strain that exceeded immunogenicity criteria for licensure of
seasonal inactivated influenza vaccines which are 40% seroconversion
and 70% seroprotection thresholds (CHMP criteria). Preliminary results
showed that 98% of subjects immunized with the plant-made vaccine
developed an immune response against the H1N1 virus. In the 5 µg group,
a four-fold increase in HI titers (seroconversion) was observed in 61%
of subjects and HI titers greater than 1:40 (seroprotection) were
developed in 83% of the subjects.

Approximately 20% of all subjects had a baseline HAI titer >=1:40 to H1N1
at day 0, either due to exposure to the ongoing pandemic virus, or past
exposure. Therefore, a sub-analysis was performed in subjects who were
H1N1 seronegative at baseline. In this population, the seroconversion
and seroprotection rates for the 5mg were 78%.

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 31, 2011 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