Medicago Receives Regulatory Approval and Commences Phase II Clinical Testing of its Avian Influenza Vaccine
QUEBEC CITY , Nov. 1 /CNW/ - Medicago Inc. (TSX: 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 II human clinical trial with its H5N1 Avian Influenza vaccine ("H5N1 vaccine"). Enrolment of volunteers is now underway.
The Phase II randomized, placebo controlled clinical trial will evaluate the safety and immunogenicity of different doses of its H5N1 vaccine. Specifically, the vaccine will be studied in approximately 255 healthy adults between the ages of 18 to 60 years. In the first part of the study healthy adults will receive an injection of either a placebo or the H5N1 vaccine at varying doses to determine the optimal dose. In the second part of the study, healthy adults will receive an injection of either a placebo or the H5N1 vaccine at the optimal dose. Interim-results of this study are expected in less than three months.
"The initiation of our Phase II clinical trial is an important step in the development of our plant-based VLP vaccines, which we believe are highly effective, cross-protective, less expensive and faster to produce than current influenza vaccines. It also demonstrates our ability to advance candidates through clinical development," said Andy Sheldon, President and CEO of Medicago. "Our platform is very versatile and to date, we have been able to produce a broad array of other proteins with potential use in the life science industry. This clinical trial therefore provides additional validation for our rapid and cost-effective technology platform offering."
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 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 24, 2010 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.
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