Bail on good newsAre they gone yet?
Medicago finds H5N1 vaccine candidate effective, safe
2009-12-21 07:14 ET - News Release
Mr. Andy Sheldon reports
MEDICAGO REPORTS POSITIVE PHASE I RESULTS FOR ITS AVIAN FLU PANDEMIC VACCINE
Medicago Inc. today released positive interim results from a phase I human clinical trial with its H5N1 avian influenza vaccine candidate (H5N1 vaccine). The vaccine was found to be safe, well tolerated and also induced a solid immune response.
"We are very pleased with the results from this study. This trial was the first ever clinical evaluation of a plant-based Influenza VLP vaccine and shows that Medicago's vaccine is safe in humans," said Andy Sheldon, president and chief executive officer of Medicago. "We believe our novel vaccine candidate, coupled with our rapid response and low-cost manufacturing system, offers a preferred option to increase the speed of a public health response in the event of a pandemic outbreak. Looking ahead, the successful completion of this trial should enable us to formalize various partner agreements. It may also allow us to access new sources of non-dilutive financing available through United States grant programs and by organizations interested in funding the development of better technologies for pandemic vaccine production."
The phase I study was designed to investigate the safety of the company's H5N1 alum-adjuvanted pandemic vaccine candidate and to provide an initial indication of the immune response. A total of 48 healthy volunteers between the ages 18 to 60 received two doses of either Medicago's vaccine at doses of five, 10 or 20 micrograms or a placebo. No serious adverse events were reported during the trial and the vaccine was found to be well tolerated at all three dose levels. Local site reactions were mild and the incidence of systemic side effects was comparable between the H5N1 vaccine groups and the placebo. As planned in the initial design, adverse event monitoring will continue for six months after administration of the second vaccine dose. The trial was conducted at the vaccine evaluation centre of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward.
Preliminary results showed that 81 per cent of immunized subjects developed an immune response against the H5N1 virus after the second immunization. A four-fold increase in HI titers from baseline in 58 per cent of subjects was observed in the 20-milligram group. HI titers greater than 1:40 were developed in 50 per cent of the subjects in the 20-milligram group. The H5N1 vaccine also induced the production of antibodies cross-reacting with two other strains of H5N1 avian influenza suggesting Medicago's vaccine potential for cross-protection.
"Results at these lower dosage levels have not been reported for an H5N1 vaccine manufactured with a novel vaccine manufacturing technology," said Nathalie Landry, vice-president of product development of Medicago. "H5N1 vaccines are poorly immunogenic in humans and are known to require repeated administrations with an adjuvant to elicit an immune response at low doses."
Full results of this trial will be submitted for publication in a scientific journal and will be available in the coming months. Based on these results, Medicago will proceed with a phase II clinical trial, expected to commence during the first half of 2010.
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. 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 per cent 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 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.
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