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Norovirus Vaccine In Human Trials

Bozeman, MT is about as far from the cruise ship routes and those closed hospital wards in England to make it about the last place you might think of when talking about a norovirus vaccine.

Yet, it is a Bozeman company, the privately held LigoCyte Pharmaceuticals Inc., which has its third human clinical trial underway for a norovirus vaccine.  The human trials of the nasally delivered, dry-powder vaccine in healthy adults will test the safety and immunogenicity of the new product.

Human trials also test how the new vaccine does against a placebo in live virus tests.

“Norovirus infections are now being recognized as a widespread problem that can have very serious consequences,” says Donald P. Beeman, chief executive officer of LigoCyte.   “The worldwide impact of this highly contagious virus has been increasingly appreciated with continued closures of hospital wards, long-term care facilities, and schools.”

Norovirus infection, commonly known as “the stomach flu,” is the most common cause of acute gastroenteritis, affecting nearly 23 million Americans annually.  Also known as “the cruise ship disease” and “the winter vomiting bug,” norovirus infection is characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea, and occasionally fever.

It is also the most common foodborne illness.

In addition to having its way on cruise ships and holiday hotels, norovirus outbreaks have disrupted schools, colleges, nursing homes, and hospitals.  Indeed, the quick spread of norovirus, has put the readiness of military units at risk.

LigoCyte’s norovirus vaccine is a needle-free, dry powder formulation based on virus like particle antigens, which are highly purified products.  It mimics the live virus, but cannot reproduce or cause illness.

LigoCyte’s vaccine formulation also includes the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline (NYSE:GSK), and chitosan (ChiSys®), under license from Archimedes Development Ltd, to enhance nasal delivery.

The live virus being used in the study is a Norwalk virus inoculum developed at the Baylor College of Medicine with funding from the National Institutes of Health.

LigoCyte was named Montana Small Business of the Year in 2007.  The immunology company is developing a new generation of vaccines for the prevention of infectious diseases.

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