Posted: Wed Aug 26, 2009 6:17 am Post subject: Medicago's VLP Approved for Phase 1 Trial H5N1
it has received clearance from Health Canada to commence a Phase I human clinical trial with its H5N1 Avian Influenza vaccine ("H5N1 vaccine"). Enrollment of volunteers is now underway.
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 up to 48 healthy volunteers between the ages 18 to 60. Volunteers will receive two doses, injected 21 days apart of either a placebo or the influenza vaccine at doses of 5, 10 or 20 micrograms. The trial will take place at the Vaccine Evaluation Center of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward. Results of this study are expected during the fourth quarter of 2009.
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 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 VLP-based vaccine has shown in preclinical studies it can provide protection against different strains of avian flu, such as the Vietnam and Turkey strains, and it may provide significant immune protection after a single dose.
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 4 weeks of obtaining the genetic sequence of a pandemic strain.
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