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Medicago, Inc. Receives Authorization From Health Canada and Commences Phase II Clinical Trial for an H5N1 Vaccine



6/11/2013 8:48:57 AM

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QUEBEC CITY, June 11, 2013 /PRNewswire/ - 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), today announced it has received clearance by Health Canada to initiate its Phase II dose-sparing clinical trial for an H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine"). All clinical lots have been produced and the trial will commence with interim results expected in the summer of 2013.

"Securing Health Canada approval to conduct this trial is an important milestone in the advancement of our pandemic influenza vaccine," said Andy Sheldon, President and CEO of Medicago. "This trial follows on from our recent positive phase I interim results which demonstrate that our vaccine candidate is in our opinion the best in class. Our ability to rapidly produce safe and efficacious vaccines is a key advantage over slower traditional methods of production. In the face of a pandemic, it will be essential for governments to deploy an effective vaccine within their borders as quickly as possible."

To date, 3 clinical trials have been performed including a total of 403 subjects. Medicago's  H5N1 vaccine candidate was found to be safe and well tolerated and induced a solid immune response. A U.S. phase I study was recently completed using a 20 µg dose of the H5 VLP vaccine with or without the Alhydrogel® (alum adjuvant) or the glucopyranosyl Lipid A (GLA-AF) adjuvant, given either intradermally (ID) or intramuscularly (IM). The results obtained revealed that all formulations were safe and well-tolerated and both alum and GLA induced antibody levels that met the 3 CHMP criteria for licensure of influenza vaccines.

The phase II dose-sparing study is designed as a multi center, observer blind, placebo-controlled study using the IM route of administration, with alum or GLA-based adjuvant in healthy adults 18 to 60 years of age. A total of 390 subjects will be randomized to receive two doses of the H5 VLP vaccine formulated with alum adjuvant or GLA-SE adjuvant or placebo. The primary endpoints are immunogenicity evaluated 21 days after each administration as well as safety and tolerability after each administration and 12 months after the last injection.  As a secondary endpoint, the immunogenicity and cross-reactive antibodies induced by the H5 VLP vaccine will be evaluated. The trial is anticipated to take 15 months to complete with initial safety and immunology data expected during the summer of 2013.

According to the Centers for Disease Control and Prevention, the highly pathogenic avian influenza A (H5N1) virus is a deadly virus that occurs mainly in birds including domestic poultry. Though relatively rare, sporadic human infections with this virus have occurred and caused serious illness and death. Because of the unpredictability of pandemic flu, efforts are being made to create and stockpile a vaccine to combat H5N1 that reduces the amount of vaccine needed per person and can be easily administered.

About Medicago
Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins to address a broad range of infectious diseases worldwide. The Company is committed to providing highly effective and competitive vaccines and therapeutic proteins based on its proprietary VLP and manufacturing technologies. Medicago is a worldwide leader in the development of VLP vaccines using a transient expression system which produces recombinant vaccine antigens in plants. This technology has potential to offer more potent vaccines with speed and cost advantages over competitive technologies, enabling the development of a vaccine for testing in approximately one 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, and supply large volumes of vaccine antigens to the world market. Medicago also intends to expand development into other areas such as biosimilars and biodefense products where the benefits of our technologies can make a significant difference. Additional information about Medicago is available at www.medicago.com.

Forward Looking Statements
This news release includes certain forward-looking statements or forward-looking information for the purposes of applicable securities laws and such statements and information are based upon current expectations, which involve risks and uncertainties associated with Medicago's business and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "anticipate", "believe", "plan", "estimate", "expect", "intend", and similar expressions to the extent they relate to Medicago or its management. The forward-looking statements are not historical facts, but reflect Medicago's current expectations regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under "Risk Factors and Uncertainties" in Medicago's Annual Information Form filed on March 28, 2013, with the regulatory authorities. Medicago assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

SOURCE Medicago Inc.



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