Medicago Announces Publication of its Phase I Study with its Pandemic H5N1 Influenza Virus-Like Particle (VLP) Vaccine Candidate
QUEBEC CITY, Jan. 5 /PRNewswire-FirstCall/ - Medicago Inc. (TSX: MDG) a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that a scientific report entitled "Preclinical and Clinical Development of Plant-Made Virus-Like Particle Vaccine against Avian H5N1 Influenza," was recently published in the peer-reviewed journal PLoS ONE. Scientists from Medicago, Research Institute of the McGill University Health Center, Montreal General Hospital, Québec, Canada, and University of Siena, Department Physiopatology Experimental Medicine and Public Health, Molecular Epidemiology Research Division, Siena, Italy, co-authored the scientific report. The paper is available online at http:// www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015559.
"This is the first time a scientific report on a clinical trial for a plant-based influenza VLP vaccine in humans is published in a peer-reviewed journal. It is a great accomplishment and demonstrates our leadership in the development of new, affordable and rapid approaches to the production of vaccines." said Louis Vezina, Chief Scientific Officer of Medicago. "Looking ahead, we are in a good position to present Phase II clinical trial data for our H5N1 VLP vaccine candidate later this month which we believe will further validate our rapid and cost-effective VLP vaccine technology offering."
The publication reports final results from the Company's H5N1 vaccine Phase I clinical trial, designed to investigate the safety of its 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. The publication concluded that Medicago's H5N1 vaccine was well tolerated, safe and also induced a solid immune response suggesting that plant-based VLP vaccines should be further evaluated for use in pre-pandemic or pandemic situations. The immunogenicity of the H5N1 VLP vaccine was evaluated by Hemagglutination-Inhibition (HI), Single Radial Hemolysis (SRH) and MicroNeutralisation (MN). Results from these three assays were highly correlated and showed similar trends across doses. The report also concluded that VLPs containing the hemagglutinin (HA) protein of H5N1 influenza (A/Indonesia/5/05) can induce cross-reactive antibodies in ferrets and humans. In addition, Medicago demonstrated that a candidate VLP vaccine can be generated within 3 weeks of receiving the genetic sequence information.
Medicago is committed to provide highly effective and affordable vaccines based on proprietary Virus-Like Particle (VLP) and manufacturing technologies. Medicago is developing VLP vaccines to protect against H5N1 pandemic 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 genetic sequences from a pandemic strain. 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.
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Posted: January 2011