Medicago reports positive Phase II H5N1 vaccine tests

Phase II human clinical trials with Medicago’s H5N1 avian influenza virus-like particles vaccine candidate have been positive, showing the vaccine candidate to be safe, well-tolerated and capable of inducing a solid immune response.

"We believe our phase II interim study results continue to show impressive findings,"  Andy Sheldon, president and CEO of Medicago said. "These data demonstrate that our H5N1 vaccine is both safe and introduces cross-reactive antibody responses against multiple strains of H5N1.

"We also believe that our effective VLP vaccine, produced in less than one month, is capable of providing a rapid response to an influenza pandemic, a much needed solution. With these encouraging results in hand, we will proceed with part B of our Phase II study and look forward to reporting final data in Q2 2011."

The study used 135 healthy volunteers who were immunized at three dosage levels in order to determine an optimal dose. No adverse reactions were noted and the vaccine was determined to be safe at all levels. The data further showed that the H5N1 vaccine produced a robust hemagglutination inhibition antibody response against the H5N1 virus strain.

"These results demonstrate that we have a safe product, as our H5N1 vaccine was well tolerated at all levels," Nathalie Landry, vice president of product development at Medicago, said. "We are the first novel vaccine manufacturing technology to report an immune response of this kind at such low dosage levels. This is especially important as H5N1 vaccines are known to be poorly immunogenic in humans. The results indicate that we have a solid vaccine manufacturing platform and we look forward to continuing the clinical advancement of our vaccine candidates."