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Medicago Receives Regulatory Approval and Commences Phase II Clinical Testing of its Avian Influenza VaccineQUEBEC CITY, Nov 01, 2010 /PRNewswire via COMTEX News Network/ --
MedicagoInc. (TSX: MDG) a biotechnology company focused on developing highlyeffective and affordable vaccines based on proprietary manufacturingtechnologies and Virus-Like Particles (VLPs), today announced that ithas received clearance from Health Canada to commence a Phase II humanclinical trial with its H5N1 Avian Influenza vaccine ("H5N1 vaccine").Enrolment of volunteers is now underway.
The Phase IIrandomized, placebo controlled clinical trial will evaluate the safetyand immunogenicity of different doses of its H5N1 vaccine.Specifically, the vaccine will be studied in approximately 255 healthyadults between the ages of 18 to 60 years. In the first part of thestudy healthy adults will receive an injection of either a placebo orthe H5N1 vaccine at varying doses to determine the optimal dose. In thesecond part of the study, healthy adults will receive an injection ofeither a placebo or the H5N1 vaccine at the optimal dose.Interim-results of this study are expected in less than three months.
"Theinitiation of our Phase II clinical trial is an important step in thedevelopment of our plant-based VLP vaccines, which we believe arehighly effective, cross-protective, less expensive and faster toproduce than current influenza vaccines. It also demonstrates ourability to advance candidates through clinical development," said AndySheldon, President and CEO of Medicago. "Our platform is very versatileand to date, we have been able to produce a broad array of otherproteins with potential use in the life science industry. This clinicaltrial therefore provides additional validation for our rapid andcost-effective technology platform offering."
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