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Medicago starts human trial for H5N1 bird flu vaccine
2009-10-01 07:34 MT - News Release
Mr. Andy Sheldon reports
MEDICAGO BEGINS HUMAN CLINICAL TESTING WITH ITS AVIAN FLU PANDEMIC VACCINE
Medicago Inc. has initiated a phase I human clinical trial with its H5N1 avian influenza vaccine (H5N1 vaccine). Enrolment is continuing and vaccination has commenced. The phase I placebo-controlled, double-blind, dose-escalating study will evaluate safety, tolerability and the immune response of the company's H5N1 vaccine candidate in 48 healthy volunteers between the ages 18 to 60. Results of this study are expected during the fourth quarter of 2009.
"This first human study with our lead vaccine candidate confirms Medicago's development as a clinical-stage company," said Louis P. Vezina, chief scientific officer of Medicago. "This is an important step for our H5N1 vaccine candidate, which has the potential to be highly effective, cross-protective, less expensive and faster to produce than current influenza vaccines."
About Medicago's pandemic flu vaccine candidate
Medicago's H5N1 vaccine candidate was formulated to protect against the avian influenza virus. It is manufactured in Nicotiana benthamiana, a relative of the tobacco plant, using the company's proprietary virus-like particle technology. VLPs have several advantages over traditional influenza vaccines. They resemble the 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 VLP-based vaccine has shown in preclinical studies it can provide cross-protection against different strains of avian flu, such as the Vietnam and Turkey strains. As 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 the pandemic strain. This is in contrast with all current manufacturing technologies which rely on strain adaptation, leading to an additional four to six months before vaccine production can be initiated.
We seek Safe Harbor.
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