Positive interim results from Medicago's H5N1 vaccine Phase I human clinical trial

Dec 21 2009

- Company's results amongst the best for influenza vaccine manufacturing technologies -

Medicago Inc. (TSX-V: MDG) a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

"We are very pleased with the results from this study. This trial was the first ever clinical evaluation of a plant-based Influenza VLP vaccine and shows that Medicago's vaccine is safe in humans," said Andy Sheldon, President and CEO of Medicago. "We believe our novel vaccine candidate, coupled with our rapid response and low cost manufacturing system offers a preferred option to increase the speed of a public health response in the event of a pandemic outbreak. Looking ahead, the successful completion of this trial should enable us to formalize various partner agreements. It may also allow us to access new sources of non-dilutive funding available through U.S. grant programs and by organizations interested in funding the development of better technologies for pandemic vaccine production."

The Phase I study was designed to investigate the safety of the Company's 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. As planned in the initial design, adverse event monitoring will continue for six months after administration of the second vaccine dose. 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 H5N1 Avian Influenza suggesting Medicago's vaccine potential for cross-protection.

"Results at these lower dosage levels have not been reported for an H5N1 vaccine manufactured with a novel vaccine manufacturing technology," said Nathalie Landry, VP Product Development of Medicago. "H5N1 vaccines are poorly immunogenic in humans and are known to require repeated administrations with an adjuvant to elicit an immune response at low doses."

Full results of this trial will be submitted for publication in a scientific journal and will be available in the coming months. Based on these results, Medicago will proceed with a Phase II clinical trial, expected to commence during the first half of 2010.