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Snip: "Under this contract, Vaxin is managing the project and clinical trials and retains worldwide rights to this product, in all other territories."
|Vaxin announces preliminary phase 1 data for pandemic influenza vaccine candidate|
| - Vaxin Inc. an emerging vaccine company, recently announced promising initial study data for its lead, intranasal influenza vaccine candidate being developed to protect humans against highly-virulent strains of influenza, including those that could result in a global pandemic. The preliminary data indicate that the vaccine against the H5N1 influenza virus, commonly referred to as “bird flu”, induced strong antibody responses and good tolerability in healthy adults.|
The findings were presented by Scott Parker, M.D., co-director of the Alabama Vaccine Research Clinic and assistant professor of medicine at the University of Alabama at Birmingham during the 28th Annual American Society for Virology Conference in Vancouver, British Columbia. The randomized, placebo-controlled, dose-escalation Phase I trial of the
intranasal influenza vaccine was designed to evaluate safety and immunogenicity of the candidate vaccine in 48 healthy subjects between the ages of 19 and 49 years of age.
The Phase I study data indicate that Vaxin’s pandemic vaccine candidate, was effective in inducing an immune response in up to 82 percent of the high dose cohort as measured by greater than twofold increase over pre-immunization background in serum micro-neutralization titers with up to 25 percent of the high dose group having a greater than fourfold increase. Additionally, anti-HA IgA antibodies were also detected post-immunization in up to 33 percent of the high dose cohort.
Work on this vaccine is being sponsored, in part, by Kolmar Korea, Co., Ltd., Vaxin’s strategic partner for the Korean marketplace. Under this contract, Vaxin is managing the project and clinical trials and retains worldwide rights to this product, in all other territories.
“I am very encouraged
by the preliminary results of this Phase I clinical trial which suggest that this vaccine may provide protection against pandemic influenza with minimal side effects,” said Bill Enright, President and CEO of Vaxin Inc. “Combined with the recent encouraging results from our other programs, these data provide further evidence suggesting the Vaxin platform can reliably deliver safe and effective influenza vaccines in pandemic situations. This early indication of an acceptable safety profile and immunity against this strain is critically important as we plan further trials to provide a solid measure of the vaccine’s potential to protect a large number of people during an influenza season.”
In preclinical studies, a single dose of this vaccine provided 100 percent protection against multiple subtypes of flu, leading researchers to believe that it may be effective against highly-virulent, life threatening strains of avian and human influenza.
Additionally, because this vaccine is produced in cell culture, not chicken eggs, as is the industry norm, Vaxin expects to greatly reduce manufacturing costs and time while eliminating concerns of allergic reactions and contamination common to currently marketed vaccines.
About Vaxin: Vaxin Inc. is an emerging clinical stage vaccine company developing needle-free, highly effective vaccines. These molecular vaccines are safely administered either in the nose or on the skin, taking the battle against diseases to the immune system’s front lines where the diseases are attacking, rather than injecting the vaccine inside the body where the body’s immune response is actually weaker. This also allows Vaxin’s vaccines to be mass administered by personnel without sophisticated medical training. As a vaccine delayed may be a vaccine denied, it is crucial to produce vaccines in a timely manner, especially in the event of a pandemic or bioterrorist
attack. The company’s technology platform also provides a critical tool for the rapid production of vaccines against influenza, avian influenza, anthrax, and Alzheimer’s disease utilizing molecular techniques and state of the art cell culture based manufacturing. Vaxin’s vaccines are not dependent on chicken eggs and can therefore be more reliably produced even in the event of avian epidemics.
Vaxin’s unique technology was developed by Dr. De-chu C. Tang, Vaxin’s scientific founder and Vice President of Research. Unlike current vaccines, which typically use a weakened form of the targeted disease, such as the influenza virus, Vaxin’s molecular vaccines are created by inserting only a piece of the influenza virus, the antigen, into a benign delivery vehicle. This “Trojan Horse” method increases the safety of the vaccine and virtually eliminates the risk of a vaccine reverting to a disease causing agent. Needle-free, non-replicating,
molecular vaccines also have many other advantages. Patients clearly prefer vaccines which are not injected because there is no fear of needles or the pain they can cause. Vaxin’s technology also has applications for animal health uses. Automated in ovo (in the egg) vaccination is the method of choice for the mass immunization of poultry because of the ease of administration and lower costs. Unlike most technologies that have been tried, Vaxin’s technology provides the ability to administer a protective avian influenza vaccine in ovo without harming the embryo.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking
Contact: Bill Enright
Randi J. Airola, (c) 517-819-5926