QUEBEC CITY, Aug. 25 /CNW/ - Medicago Inc. (TSX-V: 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 I human clinical trial with its H5N1 Avian Influenza vaccine ("H5N1
vaccine"). Enrollment of volunteers is now underway.
The Phase I placebo-controlled, double-blind, dose-escalating study will
evaluate safety, tolerability and the immune response of the Company's H5N1
vaccine candidate in up to 48 healthy volunteers between the ages 18 to 60.
Volunteers will receive two doses, injected 21 days apart of either a placebo
or the influenza vaccine at doses of 5, 10 or 20 micrograms. The trial will
take place at the Vaccine Evaluation Center of McGill University in Montreal,
Canada, under the supervision of Dr. Brian Ward. Results of this study are
expected during the fourth quarter of 2009.
"The acceptance of our Clinical Trial Application by Health Canada
represents a major milestone in the company's development of novel influenza
vaccines. It is a testament to the quality of our technology and demonstrates
our ability to advance candidates towards human trials," said Andy Sheldon,
President and CEO of Medicago. "This trial will be the first in which a
plant-based vaccine will be injected into humans in Canada. We believe we have
a compelling vaccine against influenza - a candidate, which at low dosage may
protect against different strains of influenza that have the potential of
becoming a pandemic. Combined with our rapid response and low cost
manufacturing capabilities, we believe our vaccine can address an unmet gap in
pandemic influenza preparedness efforts."
"All of our studies to date confirm that we have a safe and effective
vaccine candidate entering human trials," said Nathalie Landry, VP Product
Development of Medicago. "The data collected will support further clinical
trials expected in 2010. As our influenza vaccines candidates are produced
using the same manufacturing platform, favourable safety information from this
trial may support our other programs and reduce overall development timelines.
Furthermore, by conducting this first trial in Canada we will also have the
opportunity to build a robust application that will satisfy regulatory
requirements of U.S. and European regulatory agencies at a later stage of
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 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 VLP-based vaccine has shown
in preclinical studies it can provide protection against different strains of
avian flu, such as the Vietnam and Turkey strains, and it may provide
significant immune protection after a single dose. 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. Because Medicago's technology requires the genetic
sequence of a viral strain and not the live influenza virus, vaccines can be
manufactured within 4 weeks of obtaining the genetic sequence of a pandemic
strain. This is in contrast with all current manufacturing technologies which
rely on strain adaptation, a process that requires an additional 4-6 months
before vaccine production can be initiated.
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in the policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release
For further information:
For further information: Medicago, Inc., Andy Sheldon, President and
CEO, (418) 658-9393; Medicago Inc., Arianna Vanin, Director, Investor
Relations, (514) 796-3993