DelSite to Test Needle-Free Bird Flu Vaccine

DelSite Biotechnologies, a wholly owned subsidiary of Carrington Laboratories, received a shipment of clinical-grade bird flu antigen and will commence production of a nasal powder bird flu vaccine. The vaccine is scheduled to enter a Phase I human clinical trial later this year.

Avian Flu is one of many maladies that achieved celebrity status over the past few years. Ebola was a media phenomenon back in the nineties; SARS and MRSA have both had their 15 minutes in the spotlight.

Public concern peaked over Avian Flu sometime in the first quarter of 2005 and many medical experts still believe there is a possibility of avian flu becoming a human contagion.

Because influenza viruses are RNA viruses, they have less fidelity during replication; errors in their genetic material tend to accumulate, resulting in mutations that may allow the virus to infect new species.

Says Udaya B.S. Prakash, a pulmonologist with Mayo Clinic of Minnesota, “There is a fair chance that the avian flu virus might mutate and become a human virus.”

DelSite’s vaccine will use the company’s GelVac nasal powder delivery platform, for easy, needle-free, self-administration. The vaccine is stable at room temperature and has a shelf life of three years – which, the company reports, might enable the potential stockpiling in the event of a pandemic.

Unfortunately, because influenza viruses mutate frequently, the antigens and proteins in viruses change making old vaccines ineffective against a new form of influenza. Even if you make a vaccine, it has to be repeatedly prepared for human protection. It is difficult to produce vaccine in mass quantities on a frequent basis.

As a prelude to DelSite’s Phase I trials, in January 2008 toxicology studies were successfully completed on a GelVac nasal powder influenza vaccine. The GelVac nasal powder platform has also successfully completed a Phase I safety study in which the device provided consistent delivery (>90%) of the powder to the desired site in the nose.

Carlton E. Turner, PhD, Carrington’s president and CEO, commented,

“We are focusing our full attention on advancing DelSite’s GelVac nasal powder delivery platform for vaccines and therapeutics, and the H5N1 bird flu antigen was selected specifically for this effort. We completed all toxicology studies last year and reported results in January 2008. Receiving the current shipment of the non-egg-based, clinical-grade bird flu antigen for human studies was the next step in our efforts. Our regulatory pathway has been determined with the FDA, and we intend to proceed with clarity of purpose to the Phase I safety and effectiveness human trial with the nasal powder bird flu vaccine later this year.”

Carrington has invested more than $54 million in DelSite in the past few years. The company offers the only FDA approved nasal flu vaccine, FluMist.

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