Medicago announces a single low dose of its H5 VLP Vaccine achieves 100%
cross-protection in lethal challenge study in ferrets
QUEBEC CITY, Sept. 8 /CNW/ - Medicago Inc. (TSX: MDG), a clinical-stage biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that a single low dose of its pandemic vaccine formulated for the H5N1 Indonesia strain of Avian flu provided 100% cross-protection in ferrets against a lethal challenge with the highly virulent Vietnam Influenza virus. H5N1 vaccines are known to require repeated administrations to elicit an antibody response. Medicago is believed to be the first company to demonstrate full cross-protection in a heterogeneous challenge with only a single dose of its H5N1 vaccine in the ferret model.
Medicago successfully completed a Phase I clinical trial for its H5 VLP vaccine in December 2009 and will be initiating its Phase II clinical trial next quarter. During this time, the Company continued to further explore the immune response of its VLPs through additional animal studies to better understand the strength of its product.
In this study, ferrets were vaccinated with a single 1.9 (micro)g dose of the Company's clinical grade VLP vaccine made for the Indonesia H5N1 Avian Influenza virus (A/Indonesia/5/05). Animals were then challenged with a lethal dose of the Vietnam influenza virus (A/Vietnam/1203/04). All the vaccinated ferrets survived the lethal challenge while all non-vaccinated ferrets died within 7 days. As the influenza virus replicates in a similar way in ferrets and humans and causes similar symptoms and disease, these protection data are highly significant.
"This is a solid demonstration that we have a very good antigen and technology. We believe our VLPs elicit a broader and more efficient immune response than the traditional egg based production method," said Andy Sheldon, President and CEO of Medicago. "We believe our low dose cross-protective vaccine is highly desirable in face of pandemic as strains may mutate rendering current stockpiled vaccines ineffective. We continue to advance the clinical development of our H5 VLP vaccine with the initiation of our phase II clinical trial next quarter."
About Medicago
Medicago is committed to providing highly effective and affordable vaccines based on proprietary Virus-Like Particle (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. Their lead vaccine candidate, H5N1, has successfully completed a PI clinical trial and will be entering a PII clinical trial in 2010. Medicago's technology has the 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.
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For further information: Medicago, Inc., Andy Sheldon, President and CEO, (418) 658-9393; Medicago Inc., Christina Cameron, Investor Relations Manager, (418) 658-9393 x156
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