Medicago receives authorization for phase II clinical trial
There have been three medical trials performed on a total of 403 subjects for Medicago's H5N1 vaccine. Those trials showed the vaccine to be safe and well tolerated.
"Securing Health Canada approval to conduct this trial is an important milestone in the advancement of our pandemic influenza vaccine," Andy Sheldon, president and CEO of Medicago, said. "This trial follows on from our recent positive phase I interim results which demonstrate that our vaccine candidate is in our opinion the best in class. Our ability to rapidly produce safe and efficacious vaccines is a key advantage over slower traditional methods of production. In the face of a pandemic, it will be essential for governments to deploy an effective vaccine within their borders as quickly as possible."
The phase II dose-sparing study will be a multi-center observer blind, placebo-controlled study that will use the IM route of administration. A total of 390 subjects, from the ages of 18 to 60, are planned to be used in the phase II clinical studies, which will take around 15 months to complete.
Medicago is a clinical-stage biopharmaceutical company that develops novel vaccines and therapeutic proteins. Its vaccines and proteins are used to address varying infectious disease from around the world.