Recent results

Furthering the development of our H5N1 pandemic influenza VLP vaccine is our top priority. On December 21, 2009, we reported positive interim results from a Phase I human clinical trial with our H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

The Phase I study was designed to investigate the safety our H5N1 alum-adjuvanted pandemic vaccine candidate and to provide an initial indication of the immune response. A total of 48 healthy volunteers between the ages 18 to 60 received two doses of either Medicago's vaccine at doses of 5, 10 or 20 micrograms (mcg) or a placebo. No serious adverse events were reported during the trial and the vaccine was found to be well tolerated at all three dose levels. Local site reactions were mild and the incidence of systemic side effects was comparable between the H5N1 vaccine groups and the placebo. The trial was conducted at the Vaccine Evaluation Center of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward. Preliminary results showed that 81% of immunized subjects developed an immune response against the H5N1 virus after the second immunization. A four-fold increase in HI titers from baseline in 58% of subjects was observed in the 20 mcg group. HI titers greater than 1:40 were developed in 50% of the subjects in the 20 mcg group. The H5N1 vaccine also induced the production of antibodies cross-reacting with two other strains of H5N1Avian Influenza suggesting Medicago's vaccine potential for cross-protection.