- All tested doses were found safe and well-tolerated -
- A single dose of 5 µg met the 3 CHMP immunogenicity criteria -
QUEBEC CITY, June 8, 2011 /PRNewswire/ - Medicago Inc. (TSX: MDG), a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive results from a U.S. Phase I human clinical trial with its seasonal influenza vaccine candidate ("H1N1 vaccine"). All vaccine doses were found to be safe, well tolerated and also induced a solid immune response. Based on these results and subject to regulatory approval, Medicago intends to proceed with a U.S. Phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains.
"These positive U.S. clinical trial results are an important milestone as they continue to demonstrate that our rapid plant-based vaccine technology is both safe and effective," said Andy Sheldon, President and CEO of Medicago. "Our VLP vaccine was well-tolerated at all dosage levels. In addition, all dosage levels, including our lowest 5ug dose, generated a robust immune response exceeding the CHMP (Committee for Medicinal Products for Human use) immunogenicity criteria. These remarkable results are a testament to the quality of our VLP vaccine technology. We continue to believe our effective vaccine candidate, coupled with our rapid response and low cost manufacturing system offers unique advantages in the development of seasonal and pandemic influenza vaccine candidates."
Study Design
The U.S. Phase I study was designed to investigate the safety of the Company's H1N1 vaccine candidate and to provide an initial indication of the immune response. A total of 100 healthy volunteers between the ages 18 to 49 received one of the following; a single non-adjuvanted dose of Medicago's H1N1 vaccine at varying doses (5ug, 13ug, 28ug), an injection of the placebo or an H1N1 vaccine from a licensed trivalent vaccine.
Safety Results
No serious adverse events were reported during the trial and the vaccine was found to be well tolerated at all three dosage levels. Local site reactions were mild and the incidence of systemic side effects was comparable between the H1N1 vaccine groups and the placebo. As planned in the initial design, adverse event monitoring will continue for six months.
Immunogenicity Results
A single non-adjuvanted injection of the H1N1 Influenza VLP vaccine at doses of 5μg, 13μg, and 28μg induced immune responses against the H1N1 viral strain that exceeded immunogenicity criteria for licensure of seasonal inactivated influenza vaccines which are 40% seroconversion and 70% seroprotection thresholds (CHMP criteria). Preliminary results showed that 98% of subjects immunized with the plant-made vaccine developed an immune response against the H1N1 virus. In the 5 µg group, a four-fold increase in HI titers (seroconversion) was observed in 61% of subjects and HI titers greater than 1:40 (seroprotection) were developed in 83% of the subjects.
Approximately 20% of all subjects had a baseline HAI titer ≥1:40 to H1N1 at day 0, either due to exposure to the ongoing pandemic virus, or past exposure. Therefore, a sub-analysis was performed in subjects who were H1N1 seronegative at baseline. In this population, the seroconversion and seroprotection rates for the 5μg were 78%.
About Seasonal Influenza
Influenza is a contagious respiratory illness that can cause mild to severe illness, and at times can lead to death. The Centers for Disease Control and Prevention ("CDC") states that the best way to prevent seasonal flu is by getting a seasonal flu vaccination each year. According to CDC, each year in the United States on average, 5% to 20% of the population gets the flu; on average, more than 200,000 people are hospitalized from flu-related complications, and; about 36,000 people die from flu-related causes. Some people, such as elderly people, young children, and people with certain health conditions, are at high risk for serious flu complications. According to Datamonitor, global market projections of seasonal influenza are expected to increase from $2.8 billion in 2008/2009 to $6.3 billion in 2018/2019.
About Medicago
Medicago is a clinical-stage biotechnology company, developing effective and competitive vaccines based on proprietary Virus-Like Particles (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against pandemic and seasonal influenza, using a transient expression system which produces recombinant vaccine antigens in non-transgenic plants. This technology has potential to offer advantages of speed and cost over competitive technologies. It could deliver a vaccine for testing in about a month after the identification and reception of the genetic sequence. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market. Additional information about Medicago is available at www.medicago.com.
Forward Looking Statements
This news release includes certain forward-looking statements that are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risks Factors and Uncertainties" in Medicago's Annual Information Form filed on March 31, 2011 with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.
SOURCE Medicago Inc.