Nov 1 2010
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."