Medicago

Medicago Reports Positive Phase I Results for its Avian Flu Pandemic Vaccine

    Quebec City (ots/PRNewswire) - Medicago Inc.  a biotechnology company focused on developing  highly effective and affordable vaccines based on proprietary manufacturing  technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase I human clinical trial with its H5N1 Avian Influenza  vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well  tolerated and also induced a solid immune response.

    "We are very pleased with the results from this study. This trial was the  first ever clinical evaluation of a plant-based Influenza VLP vaccine and  shows that Medicago's vaccine is safe in humans," said Andy Sheldon,  President and CEO of Medicago. "We believe our novel vaccine candidate,  coupled with our rapid response and low cost manufacturing system offers a  preferred option to increase the speed of a public health response in the  event of a pandemic outbreak. Looking ahead, the successful completion of  this trial should enable us to formalize various partner agreements. It may also allow us to access new sources of non-dilutive funding available through  U.S. grant programs and by organizations interested in funding the  development of better technologies for pandemic vaccine production."

    The Phase I study was designed to investigate the safety of the Company's  H5N1 alum-adjuvanted pandemic vaccine candidate and to provide an initial  indication of the immune response. A total of 48 healthy volunteers between  the ages 18 to 60 received two doses of either Medicago's vaccine at doses of  5, 10 or 20 micrograms (mcg) or a placebo. No serious adverse events were  reported during the trial and the vaccine was found to be well tolerated at  all three dose levels. Local site reactions were mild and the incidence of systemic side effects was comparable between the H5N1 vaccine groups and the  placebo. As planned in the initial design, adverse event monitoring will  continue for six months after administration of the second vaccine dose. The  trial was conducted at the Vaccine Evaluation Center of McGill University in  Montreal, Canada, under the supervision of Dr. Brian Ward.

    Preliminary results showed that 81% of immunized subjects developed an  immune response against the H5N1 virus after the second immunization. A four- fold increase in HI titers from baseline in 58% of subjects was observed in  the 20 mcg group. HI titers greater than 1:40 were developed in 50% of the  subjects in the 20 mcg group. The H5N1 vaccine also induced the production of  antibodies cross-reacting with two other strains of H5N1 Avian Influenza suggesting Medicago's vaccine potential for cross-protection.

    "Results at these lower dosage levels have not been reported for an H5N1  vaccine manufactured with a novel vaccine manufacturing technology," said  Nathalie Landry, VP Product Development of Medicago. "H5N1 vaccines are  poorly immunogenic in humans and are known to require repeated  administrations with an adjuvant to elicit an immune response at low doses."

    Full results of this trial will be submitted for publication in a scientific journal and will be available in the coming months. Based on these  results, Medicago will proceed with a Phase II clinical trial, expected to  commence during the first half of 2010.

    About Medicago's pandemic flu vaccine candidate  

    Medicago's H5N1 vaccine candidate was formulated to protect against the  Indonesian influenza virus. It is manufactured in Nicotiana benthamiana, a  relative of the tobacco plant, using the Company's proprietary VLP  technology. VLPs may have several advantages over traditional flu vaccines.  They are made to look like a virus, allowing them to be recognized readily by  the body's immune system, however, they lack the core genetic material making  them non-infectious and unable to replicate. FDA-approved H5N1 influenza vaccines in the United States require two 90-microgram doses, administered at  least four weeks apart to achieve appropriate level of antibodies in 44% of  vaccinated individuals. Because Medicago's technology requires the genetic  sequence of a viral strain and not the live influenza virus, vaccines can be  manufactured within four weeks of obtaining the genetic sequence of a  pandemic strain. This is in contrast with current manufacturing technologies  which rely on strain adaptation and can only deliver a vaccine six to nine  months after a pandemic is declared.

    About Medicago  

    Medicago is committed to provide highly effective and affordable vaccines  based on proprietary Virus-Like Particle (VLP) and manufacturing  technologies. 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. This technology has  potential to offer advantages of speed and cost over competitive  technologies. It could deliver a vaccine for testing in about a 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 strikes and to supply large  volumes of vaccine antigens to the world market. Additional information about  Medicago is available at http://www.medicago.com.

    Forward Looking Statements  

    This news release includes certain forward-looking statements that are  based upon current expectations, which involve risks and uncertainties  associated with Medicago's business and the environment in which the Company  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  "Risks Factors and Uncertainties" in Medicago's Annual Information Form filed  on March 25, 2009 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.

    Neither TSX Venture Exchange nor its Regulation Services Provider (as  that term is defined in the policies of the TSX Venture Exchange) accepts  responsibility for the adequacy or accuracy of this release.

    For further information: Medicago, Inc., Andy Sheldon, President and CEO,  +1-418-658-9393 x135; Medicago Inc., Pierre Labbe, Chief Financial Officer,  +1-418-658-9393 x135

ots Originaltext: Medicago
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
CONTACT:  For further information: Medicago, Inc., Andy Sheldon,
Presidentand CEO, +1-418-658-9393 x135; Medicago Inc., Pierre Labbe,
Chief FinancialOfficer, +1-418-658-9393 x135



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