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Market: TSXV
Sector: Pharmaceuticals
EPIC: MDG
Medicago
www.medicago.com/en

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.

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Medicago reports positive, phase 2 final study results for Avian flu vaccine

30th Jun 2011, 11:11 am by Olivia D'Orazio
Medicago reports positive, phase 2 final study results for Avian flu vaccine

Medicago (TSE:MDG) announced Thursday that the second part of its phase two clinical study  for its H5N1 Avian flu vaccine found strong final results.

The company said the part B study confirmed the robust immune response that was originally observed in the part A study, as induced by the H5N1 vaccine, which is manufactured in Nicotiana benthamiana, a relative of the tobacco plant. The study also confirmed safety and tolerability, as well as the efficacy of the optimal 20 ug dosage.

The trial immunized 120 patients with Medicago's H5N1 vaccine. Subjects were administered two doses, 21 days apart, then evaluated 21 days after the final dose.

In the 18 to 49 age group, 77% of subjects developed an immune response against the H5N1 virus after the second dose.
Medicago's H5N1 vaccine is based on the biotech company's proprietary virus-like particles (VLP) technology. The VLPs are designed to resemble a virus, initiating the body's immune response.

However, they are unable to duplicate and only require a genetic sequence, not the live virus itself. This allows vaccine production time to be condensed to a few weeks after a pandemic is declared, from up to nine months.

"These positive Phase II clinical trial results continue to demonstrate that our rapid plant-based vaccine technology produces VLP vaccines that are safe and among the most effective of the industry," said president and CEO, Andy Sheldon.

"Our results demonstrated similar efficacy in the older and younger volunteer age groups which is a potential differential advantage over other technologies."

Medicago, whose U.S. vaccine facility in North Carolina will be operational this fall, said the phase II study results support the effectiveness of its plant-based and VLP vaccine platforms.

Based in Quebec, Medicago said it expects its seasonal flu vaccine to enter clinical trials in the second half of the year.

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