- Company successfully completes final preclinical studies with pandemic
flu vaccine -
QUEBEC CITY, July 16 /CNW/ - 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 announced that it has reached an important milestone in the development of its pandemic influenza vaccines with the successful completion of preclinical studies for its H5N1 Avian Influenza VLP vaccine. In the final preclinical study performed in ferrets, the Company demonstrated that at very low doses, its pandemic vaccine formulated for the H5N1 Indonesia strain of Avian flu provided 100% protection against a lethal challenge with the highly virulent Vietnam Influenza virus. Current approved pandemic flu vaccines only provide protection against the viral strain they were formulated for. The Company also completed a safety study in rats which showed the vaccine was well-tolerated and did not produce significant side effects. These findings will enable Medicago to complete its planned Clinical Trial Application ("CTA") to support initiation of a Phase I clinical trial targeted to begin this quarter.
The objective of Medicago's ferret study was to determine the protective efficacy and optimal dosage of its H5N1 VLP vaccine. The ferret is the most relevant and recognized animal model for evaluating the effectiveness of influenza vaccines in humans because ferrets exhibit similar clinical symptoms as humans. At the start of the study, ferrets were vaccinated with a range of doses of the Company's clinical grade VLP vaccine made for the Indonesian strain of H5N1 Avian Influenza. Animals were then challenged with a lethal dose of the Vietnam influenza virus (A/Vietnam/1194/04). The results demonstrated that ferrets vaccinated with doses of 1.8 and 3.7 micrograms were fully protected when exposed to this lethal virus, while non-vaccinated animals did not survive.
"We are extremely proud of these results as it is a solid demonstration of the capacity of our vaccine to protect against different strains of avian flu and potentially against new emerging strains of H5N1," said Andy Sheldon, President and CEO of Medicago. "A low dose cross-protective vaccine is highly desirable in face of pandemic as strains may mutate rendering current stockpiled vaccines ineffective. With these robust ferret challenge results and the recently completed safety work in rats, we are now able to advance our product into clinical trials this quarter."
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 press release contains forward-looking statements which reflect Medicago's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. Medicago disclaims any obligation to update these forward-looking statements.
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