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Medicago Inc MDCGF



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Post by sharewealthon Jul 16, 2009 9:14am
176 Views
Post# 16141881

woo hoo..clinical trials here we go

woo hoo..clinical trials here we go

CNW Group Portfolio E-Mail

MEDICAGO INC.
Transmitted by CNW Group on : July 16, 2009 09:00

Medicago's Avian flu pandemic vaccine achieves 100% protection in a lethal challenge study in ferrets

 - Company successfully completes final preclinical studies with pandemic flu vaccine - QUEBEC CITY, July 16 /CNW/ - Medicago Inc. (TSX-V: MDG) a biotechnologycompany focused on developing highly effective and affordable vaccines basedon proprietary manufacturing technologies and Virus-Like Particles (VLPs),today announced that it has reached an important milestone in the developmentof its pandemic influenza vaccines with the successful completion ofpreclinical studies for its H5N1 Avian Influenza VLP vaccine. In the finalpreclinical study performed in ferrets, the Company demonstrated that at verylow doses, its pandemic vaccine formulated for the H5N1 Indonesia strain ofAvian flu provided 100% protection against a lethal challenge with the highlyvirulent Vietnam Influenza virus. Current approved pandemic flu vaccines onlyprovide protection against the viral strain they were formulated for. TheCompany also completed a safety study in rats which showed the vaccine waswell-tolerated and did not produce significant side effects. These findingswill enable Medicago to complete its planned Clinical Trial Application("CTA") to support initiation of a Phase I clinical trial targeted to beginthis quarter. The objective of Medicago's ferret study was to determine the protectiveefficacy and optimal dosage of its H5N1 VLP vaccine. The ferret is the mostrelevant and recognized animal model for evaluating the effectiveness ofinfluenza vaccines in humans because ferrets exhibit similar clinical symptomsas humans. At the start of the study, ferrets were vaccinated with a range ofdoses of the Company's clinical grade VLP vaccine made for the Indonesianstrain of H5N1 Avian Influenza. Animals were then challenged with a lethaldose of the Vietnam influenza virus (A/Vietnam/1194/04). The resultsdemonstrated that ferrets vaccinated with doses of 1.8 and 3.7 micrograms werefully protected when exposed to this lethal virus, while non-vaccinatedanimals did not survive. "We are extremely proud of these results as it is a solid demonstrationof the capacity of our vaccine to protect against different strains of avianflu and potentially against new emerging strains of H5N1," said Andy Sheldon,President and CEO of Medicago. "A low dose cross-protective vaccine is highlydesirable in face of pandemic as strains may mutate rendering currentstockpiled vaccines ineffective. With these robust ferret challenge resultsand the recently completed safety work in rats, we are now able to advance ourproduct into clinical trials this quarter."  
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