The vaccine Medicago plans to produce from tobacco leaves at its new Research Triangle Park factory was safe and well tolerated in human volunteers involved in a Phase I clinical trial, the company has reported to the U.S. Food and Drug Administration.
That opens the door to a Phase IIa trial to see if its three-strain, or trivalent, vaccine is effective against the H1N1, H3N2 and B seasonal flu strains.
Medicago, headquartered in Quebec City, Canada, is developing its vaccine based on virus-like particles that can be grown quickly in large quantities within the cells of tobacco leaves, then extracted and made into vaccine.
The $42 million factory and greenhouse campus here is the first of its kind in the world, and contributes to North Carolina’s global reputation as “vaccine central.”
The company expects to occupy the facility by the end of 2011.