-Presentation of Positive Interim Phase I Clinical Trial results for an H5N1 Vaccine with GLA Adjuvant-
QUEBEC CITY, and SEATTLE, WA, April 9, 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) and, IDRI (Infectious Disease Research Institute), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, today announced that they will be presenting positive interim Phase I clinical results for their H5N1 Avian Influenza VLP vaccine candidate "H5N1 vaccine" at the World Vaccine Congress. The meeting is being held at the Gaylord National Hotel and Convention Center in Washington, DC, April 16-18, 2013.
Dr. Steven Reed, Founder, President, & Chief Scientific Officer, IDRI, and Dr. Brian Ward, Professor of Medicine & Microbiology, McGill University, member of Medicago's scientific advisory committee, will be presenting at the World Vaccine Congress on April 17, 2013, at 2:35 p.m. EST. The presentation, titled "H5N1 Phase 1 clinical trial combining Medicago's VLP vaccine with IDRI's GLA adjuvant formulation," will discuss preliminary safety and immunology data from the ongoing H5N1 vaccine clinical trial.
The Phase I clinical trial, which commenced in September 2012, enrolled 100 healthy adult volunteers, aged 18-49 years, at three locations in the U.S., testing for safety and immune response. The vaccine was also tested in comparison to Medicago's H5N1 vaccine with alum. The trial is funded by a multi-million dollar grant IDRI received from the Defense Advanced Research Projects Agency (DARPA), a division of the United States Department of Defense, to investigate the safety and immunogenicity of a novel adjuvant with a Nicotiana benthamiana produced vaccine candidate. Each study participant in the trial received two doses of a given formulation in order to collect and compare data.
The trial focused on evaluating the safety and immunogenicity of the H5N1 vaccine, combined with IDRI's Glucopyranosyl Lipid A ("GLA") adjuvant, which was administered intramuscularly or intradermally. The intradermal route of administration was also tested in comparison with intramuscular delivery, using an FDA licensed device (MicronJet600®, NanoPass Technologies) as the micro-needle device was previously shown in seasonal and pandemic flu tests to allow significant dose sparing. This study is among the first to test intradermal adjuvants.
"This trial is an important step toward development of an influenza vaccine that could be rapidly and widely administered in case of a pandemic outbreak," said Reed.
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.
The H5N1 vaccine candidate includes IDRI's GLA adjuvant, which has been exclusively licensed to Immune Design Corp. for certain fields, including influenza, and is produced in Medicago's plant-based expression system, which is speedier than the traditional route of producing flu vaccines in eggs. The adjuvant system has been combined with Medicago's vaccine candidate and other recombinant protein antigens to elicit both humoral and cell-mediated immune responses associated with protection in pathogenic animal challenge models. In animal studies, GLA has also been shown to expand the cross reactivity of antibodies induced by the H5N1 vaccine to other potential pandemic influenza strains such as H2N2.
As a nonprofit global health organization, IDRI (Infectious Disease Research Institute) takes a comprehensive approach to combat infectious diseases, combining the high-quality science of a research organization with the product development capabilities of a biotech company to create new diagnostics, drugs and vaccines. IDRI combines passion for improving human health with the understanding that it is not just what our scientists know about disease, but what we do to change its course that will have the greatest impact. Founded in 1993, IDRI has 125 employees headquartered in Seattle with more than 50 partners/collaborators around the world. For more information, visit www.idri.org.
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.
About NanoPass Technologies Ltd.
NanoPass is the developer of MicronJet600™, an FDA-registered intradermal microneedles device. NanoPass has concluded the world's first intradermal pandemic (H1N1) flu vaccine clinical study and additional seasonal flu studies, demonstrating equivalent or superior immunogenicity to standard intramuscular delivery using only 20% of the dose.
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. Such statements include but are not limited to statements about the collaboration with IDRI and the Phase I clinical trial. 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.