Medicago Inc., a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today 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, 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. 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.
