Medicago set for Phase I influenza vaccine trial

Medicago, Inc., recently announced that it has received approval from the U.S. Food and Drug Administration for Phase I clinical trials of its virus-like particle influenza vaccine candidate for the H1N1 strain.

Medicago, which is known for focusing on the development of vaccines based on proprietary manufacturing technologies and VLPs, plans to begin its trial in the coming weeks. The Phase I trial is expected to lead into Medicago’s Phase IIa trial for its seasonal trivalent vaccine with H1N1, H3N2 and B influenza strains that the company plans to conduct in 2011.

"Securing FDA approval to conduct this U.S. trial is a significant milestone in the advancement of our seasonal influenza vaccine," Andy Sheldon, president and CEO of Medicago, said. "Our recent positive phase II interim results for our avian influenza vaccine have demonstrated to date the safety and immunogenicity of our vaccine manufacturing platform and provide us solid support for the development of our seasonal vaccine candidate.

“In addition, our ability to rapidly and cost-effectively produce quality vaccines is a key advantage over traditional methods and will allow us to participate in the $2.8 billion seasonal market which is expected to grow to $6.3 billion by 2019."

The preliminary safety and immunogenicity data is expected within three months of the start of the study.