Medicago gets Health Canada clearance to initiate Phase II clinical trial for H5N1 vaccine

Jun 11 2013

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.