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Medicago receives regulatory approval to begin human clinical testing with its avian flu pandemic vaccine
Date:8/25/2009

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 clinical development."

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.

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SOURCE Medicago Inc.
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