- Phase II part B confirms results obtained in Phase II part A -
- Company's results continue to be amongst the best for influenza vaccine manufacturing technologies -
QUEBEC CITY, June 30, 2011 /PRNewswire/ - Medicago Inc. (TSX: MDG) a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive final results from a Phase II human clinical trial with its H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine"). The vaccine induced a solid immune response and was found to be safe and well tolerated.
"These positive Phase II clinical trial results continue to demonstrate that our rapid plant-based vaccine technology produces VLP vaccines that are safe and among the most effective of the industry," said Andy Sheldon, President and CEO of Medicago. "Our Phase II part B data confirms the solid results obtained in Phase II part A for optimal dosing. In addition, our results demonstrated similar efficacy in the older and younger volunteer age groups which is a potential differential advantage over other technologies."
"We soon expect to have the capacity to commercially produce these vaccines as our U.S. vaccine facility in North Carolina will be operational this fall. In addition, we believe these results further support the effectiveness of our rapid plant-based vaccine platform and the development of our seasonal flu vaccine candidate which we intend to proceed with a U.S. clinical trial in the second half of the year," continued Mr. Sheldon.
The Phase II study was designed to assess the immunogenicity, safety and tolerability of the Company's H5N1 vaccine candidate. The study was conducted in two parts. Part A of the study enrolled 135 healthy volunteers who received Medicago's vaccine at varying dosage levels or the placebo to determine the optimal dose. The volunteers received two doses 21 days apart and data was analyzed 21 days after the last dose. Part B of the study enrolled 120 additional healthy volunteers who were immunized with Medicago's vaccine at the optimal dose of 20 ug (104) or the placebo (16). These volunteers similarly received two doses 21 days apart with the data analyzed 21 days after the last dose.
The H5N1 vaccine has been tested in over 200 healthy volunteers to date, none of which have experienced any serious adverse reactions. Local site reactions were mild and the incidence of systemic side effects was comparable to those caused by the placebo. As planned in the clinical design, monitoring of adverse event will continue for six months.
The Phase II part B confirms the immunogenicity and safety results obtained in the Phase II part A for the 20 ug dose group and there were no statistical differences between the GMTs, seroconversion and seroprotection results of these two groups. In those vaccinated in the 18 to 49 age group with the 20 microgram dose, 77% of immunized subjects developed an immune response against the H5N1 virus after the second immunization, 50% of subjects had a four-fold increase in HI titers from baseline and 50% of subjects had seroprotective antibody titers. In those vaccinated in the 50 to 60 age group with the 20 microgram dose, 76% of immunized subjects developed an immune response against the H5N1 virus after the second immunization, 50% of subjects had a four-fold increase in HI titers from baseline and 50% of subjects had seroprotective antibody titers. These data show that Medicago's H5N1 vaccine induces a robust hemagglutination inhibition (HAI) antibody response against the H5N1 vaccine strain.
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. Medicago's technology only requires the genetic sequence of a viral strain and not the live influenza virus. This key difference allows vaccines to 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.
Medicago is committed to provide highly effective and competitive 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 www.medicago.com.