Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced that the first dose of vaccine has been administered thereby initiating the company's phase I H1N1 influenza VLP vaccine candidate (H1N1 vaccine) clinical trial in the United States. The primary safety and immunogenicity results for this trial are expected within three months.

“We continue to make great strides in the clinical advancement of our vaccine candidates,” said Andy Sheldon, president and CEO of Medicago. “With the initiation of this clinical trial, we are in a good position to report multiple sets of data next quarter including data from this trial and final phase II data for our pandemic influenza candidate. I am confident that the quality of data to be obtained from these clinical trials and our other solid results to date will further position Medicago as a leader in the development of rapid and cost-effective vaccines.”

The phase 1, randomized, double-blind, multi-centre, 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. This phase I trial will lead into Medicago's US 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.

Influenza is a contagious respiratory illness that can cause mild to severe illness, and at times can lead to death. The Centres 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.