QUEBEC CITY, Oct. 1 /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 initiated a Phase I human clinical trial with its H5N1 Avian Influenza vaccine ("H5N1 vaccine"). Enrolment is ongoing and vaccination has commenced. 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 48 healthy volunteers between the ages 18 to 60. Results of this study are expected during the fourth quarter of 2009.
"This first human study with our lead vaccine candidate confirms Medicago's development as a clinical stage company," said Louis P. Vézina, Chief Scientific Officer of Medicago. "This is an important step for our H5N1 vaccine candidate, which has the potential to be highly effective, cross-protective, less expensive and faster to produce than current influenza vaccines."
About Medicago's pandemic flu vaccine candidate
Medicago's H5N1 vaccine candidate was formulated to protect against the avian 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 influenza vaccines. They resemble the 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 cross- protection against different strains of avian flu, such as the Vietnam and Turkey strains. As 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 ofthe pandemic strain. This is in contrast with all current manufacturing technologies which rely on strain adaptation, leading to 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.
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