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IDRI and Medicago announce authorization to initiate a Phase 1 clinical trial for an H5N1 vaccine
Date:8/16/2012

SEATTLE, WA, and QUEBEC CITY, QC, Aug. 16, 2012 The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announce that they have been cleared by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for an H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine"). This is an important step toward development of an influenza vaccine that could be rapidly and widely administered in case of a pandemic flu outbreak. The trial is focused on evaluating the safety and immunogenicity of the H5N1 vaccine, combined with IDRI's Glucopyranosyl Lipid A ("GLA") adjuvant, which will be administered intramuscularly or intradermally. Each study participant in the trial will receive two doses of a given formulation in order to collect and compare data.

The trial is believed to be the first human test of an intradermal adjuvant a technology platform that could potentially benefit a number of worldwide vaccination programs and could result in a vaccine that could be self-administered in case of a pandemic. "A massive flu outbreak would cause a strain on health care centers as people rush to get a vaccination," said Darrick Carter, Ph.D., Vice President of IDRI's Adjuvant Technology program and co-principal investigator for the project. "Our idea is to ultimately produce a one-dose vaccine that you could give yourself imagine a flu vaccine that you can easily administer using a simple, painless microneedle device arriving in your mailbox."

"This research collaboration may provide for expedited vaccination and greater ease of use in the event of an influenza pandemic," said Andy Sheldon, Pr
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Contact: Lee Schoentrup
lee.schoentrup@idri.com
206-518-6290
Infectious Disease Research Institute
Source:Eurekalert

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