Medicago Inc a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), has received clearance from Health Canada to commence a Phase I human clinical trial with its H5N1 Avian Influenza vaccine (“H5N1 vaccine”). Enrollment of volunteers is now underway. The Phase I placebo-controlled, double-blind, dose-escalating study will evaluate safety, tolerability and the immune response of the Company’s H5N1 vaccine candidate in up to 48 healthy volunteers between the ages 18 to 60. Volunteers will receive two doses, injected 21 days apart of either a placebo or the influenza vaccine at doses of 5, 10 or 20 micrograms. The trial will take place at the Vaccine Evaluation Center of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward. Results of this study are expected during the fourth quarter of 2009. “The acceptance of our Clinical Trial Application by Health Canada represents a major milestone in the company’s development of novel influenza vaccines. It is a testament to the quality of our technology and demonstrates our ability to advance candidates towards human trials,” said Andy Sheldon, President and CEO of Medicago. “This trial will be the first in which a plant-based vaccine will be injected into humans in Canada. We believe we have a compelling vaccine against influenza – a candidate, which at low dosage may protect against different strains of influenza that have the potential of becoming a pandemic. Combined with our rapid response and low cost manufacturing capabilities, we believe our vaccine would address an unmet gap in pandemic influenza preparedness efforts.” “All of our studies to date confirm that we have a safe and effective vaccine candidate entering human trials,” said Nathalie Landry, VP Product Development of Medicago.” The data collected will support further clinical trials expected in 2010. As our influenza vaccines candidates are produced using the same manufacturing platform, favourable safety information from this trial may support our other programs and reduce overall development timelines. Furthermore, by conducting this first trial in Canada we will also have the opportunity to build a robust application that will satisfy regulatory requirements of U.S. and European regulatory agencies at a later stage of clinical development.”
