- all three standard antibody tests confirm the strong immunogenicity of Medicago's H5N1 and H1N1 VLP vaccine candidates -
QUEBEC CITY, Sept. 12, 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 announced that Dr. Brian Ward will be presenting clinical data at the Fourth ESWI Influenza Conference, Malta 2011. The presentation, entitled "Plant-Made Influenza Virus-Like Particles: An Effective way of Producing Next Generation Vaccines", will discuss the Company's positive clinical results from its phase II pandemic H5N1 influenza vaccine clinical trial and its U.S. phase I seasonal influenza trial. Medicago's H5N1 and H1N1 VLP-based vaccines were well-tolerated, produced no vaccine-related serious adverse events and induced a strong antibody response. In addition, the VLP vaccine candidates promoted cell mediated immune responses in many subjects.
Medicago's phase II clinical trial for its H5N1 VLP influenza vaccine candidate was conducted in two parts. Part A of the study enrolled 135 healthy volunteers who received Medicago's vaccine at varying dosage levels or the placebo to determine the optimal dose. The volunteers received two doses 21 days apart and data was analyzed 21 days after the last dose. Part B of the study enrolled 120 additional healthy volunteers who were immunized with Medicago's vaccine at the optimal dose of 20ug (104) or the placebo (16). These volunteers similarly received two doses 21 days apart with the data analyzed 21 days after the last dose. The Hemagglutination-Inhibition (HI), Single Radial Hemolysis (SRH) and Microneutralisation (MN) antibody tests confirmed the strong immunogenicity of the H5 VLP vaccine at all tested doses. Part B of the phase 2 trial showed that the H5 VLP vaccine is equally immunogenic in young and older adults.
Medicago's U.S. phase I clinical trial for its H1N1 VLP influenza vaccine enrolled 100 healthy volunteers between the ages 18 to 49. The volunteers 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. The Hemagglutination-Inhibition (HI), Single Radial Hemolysis (SRH) and Microneutralisation (MN) antibody tests confirmed the strong immunogenicity of a single non-adjuvanted dose of H1 VLP vaccine at all tested doses.
Dr. Brian Ward stated: "This work conclusively demonstrates that plant-made VLP vaccines bearing influenza HA molecules can elicit strong immune responses in humans. The fact that such a vaccine could be made against a new viral strain within just a few weeks using this platform would be a huge advantage in the event of a future pandemic."
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 24, 2010 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.