Medicago receives FDA regulatory clearance to initiate U.S. clinical trial for a new influenza vaccine candidate
-The Company launches the clinical development of its seasonal flu vaccine-
QUEBEC CITY, Feb. 8 /CNW/ - 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 announced it has received Food and Drug Administration ("FDA") clearance for its phase I H1N1 influenza VLP vaccine candidate ("H1N1 vaccine") clinical trial in the United States. The Company plans to initiate this trial within the coming weeks. This phase I trial will lead into Medicago's U.S. phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains which the Company plans to conduct later in 2011.
"Securing FDA approval to conduct this U.S. trial is a significant milestone in the advancement of our seasonal influenza vaccine," said Andy Sheldon, President and CEO of Medicago. "Our recent positive phase II interim results for our avian influenza vaccine have demonstrated to date the safety and immunogenicity of our vaccine manufacturing platform and provide us solid support for the development of our seasonal vaccine candidate. In addition, our ability to rapidly and cost-effectively produce quality vaccines is a key advantage over traditional methods and will allow us to participate in the $2.8 billion seasonal market which is expected to grow to $6.3 billion by 2019."
The Phase 1, randomized, double-blind, multicenter, active- and placebo-controlled dose-ranging study will evaluate the safety, tolerability and immunogenicity of a single non-adjuvanted dose of the H1N1 vaccine in 100 healthy adults 18-49 years of age. The subjects will be randomized to receive one of the following; an injection of the placebo, Medicago's H1N1 vaccine or an H1N1 vaccine from a licensed trivalent vaccine. The primary safety and immunogenicity results are expected within 3 months of the start of this study. These data will support the development of the Company's seasonal influenza VLP vaccine in the United States.
"Looking ahead, 2011 should prove to be an eventful year. We plan to have completed a phase II trial for our H5N1 vaccine, completed a U.S. phase I trial for our H1N1 vaccine, begun a U.S. phase IIa trial for seasonal vaccine and have a fully operational U.S. commercial grade vaccine production facility which will have the capacity to produce more than 40 million seasonal vaccine doses per year," added Mr. Sheldon.
About Seasonal Influenza
Influenza is a contagious respiratory illness that can cause mild to severe illness, and at times can lead to death. The Centers for Disease Control and Prevention ("CDC") states that the best way to prevent seasonal flu is by getting a seasonal flu vaccination each year. According to CDC, each year in the United States on average, 5% to 20% of the population gets the flu; on average, more than 200,000 people are hospitalized from flu-related complications, and; about 36,000 people die from flu-related causes. Some people, such as elderly people, young children, and people with certain health conditions, are at high risk for serious flu complications. According to Datamonitor, global market projections of seasonal influenza are expected to increase from $2.8 billion in 2008/2009 to $6.3 billion in 2018/2019.
Medicago is a clinical-stage biotechnology company, developing effective and competitive vaccines based on proprietary Virus-Like Particles (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against pandemic and seasonal 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 the genetic sequence. 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.For further information:
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