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Last updated on April 25, 2014 at 5:25 EDT

Medicago reports positive Phase II final results for its avian flu pandemic vaccine

June 30, 2011

- Phase II part B confirms results obtained in Phase II part A -

- Company’s results continue to be amongst the best for influenza vaccine
manufacturing technologies –

QUEBEC CITY, June 30, 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 final results
from a Phase II human clinical trial with its H5N1 Avian Influenza VLP
vaccine candidate (“H5N1 vaccine”). The vaccine induced a solid immune
response and was found to be safe and well tolerated.

“These positive Phase II clinical trial results continue to demonstrate
that our rapid plant-based vaccine technology produces VLP vaccines
that are safe and among the most effective of the industry,” said Andy
Sheldon, President and CEO of Medicago. “Our Phase II part B data
confirms the solid results obtained in Phase II part A for optimal
dosing. In addition, our results demonstrated similar efficacy in the
older and younger volunteer age groups which is a potential
differential advantage over other technologies.”

“We soon expect to have the capacity to commercially produce these
vaccines as our U.S. vaccine facility in North Carolina will be
operational this fall. In addition, we believe these results further
support the effectiveness of our rapid plant-based vaccine platform and
the development of our seasonal flu vaccine candidate which we intend
to proceed with a U.S. clinical trial in the second half of the year,”
continued Mr. Sheldon.

Study Design

The Phase II study was designed to assess the immunogenicity, safety and
tolerability of the Company’s H5N1 vaccine candidate. The study was
conducted in two parts. Part A of the study enrolled 135 healthy
volunteers who received Medicago’s vaccine at varying dosage levels or
the placebo to determine the optimal dose. The volunteers received two
doses 21 days apart and data was analyzed 21 days after the last dose.
Part B of the study enrolled 120 additional healthy volunteers who were
immunized with Medicago’s vaccine at the optimal dose of 20 ug (104) or
the placebo (16). These volunteers similarly received two doses 21 days
apart with the data analyzed 21 days after the last dose.

Safety Results

The H5N1 vaccine has been tested in over 200 healthy volunteers to date,
none of which have experienced any serious adverse reactions. Local
site reactions were mild and the incidence of systemic side effects was
comparable to those caused by the placebo. As planned in the clinical
design, monitoring of adverse event will continue for six months.

Immunogenicity Results

The Phase II part B confirms the immunogenicity and safety results
obtained in the Phase II part A for the 20 ug dose group and there were
no statistical differences between the GMTs, seroconversion and
seroprotection results of these two groups. In those vaccinated in the
18 to 49 age group with the 20 microgram dose, 77% of immunized
subjects developed an immune response against the H5N1 virus after the
second immunization, 50% of subjects had a four-fold increase in HI
titers from baseline and 50% of subjects had seroprotective antibody
titers. In those vaccinated in the 50 to 60 age group with the 20
microgram dose, 76% of immunized subjects developed an immune response
against the H5N1 virus after the second immunization, 50% of subjects
had a four-fold increase in HI titers from baseline and 50% of subjects
had seroprotective antibody titers. These data show that Medicago’s
H5N1 vaccine induces a robust hemagglutination inhibition (HAI)
antibody response against the H5N1 vaccine strain.

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. Medicago’s technology only requires the genetic sequence of
a viral strain and not the live influenza virus. This key difference
allows vaccines to 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 competitive
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 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