LigoCyte Pharmaceuticals Initiates U.S. Clinical Trial Of Norovirus Vaccine

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LigoCyte Pharmaceuticals Inc. announced today that it has initiated the Phase I clinical trial of its investigational Norovirus vaccine at the University of Maryland Medical Center.

The study will assess safety and immunogenicity of LigoCyte's intranasally-delivered, dry powder vaccine in healthy adults.

"Norovirus infections are now being recognized as a disease with extensive consequences," said Donald P. Beeman, CEO and chairman of the board at LigoCyte. "The impact of this highly contagious virus is just now being appreciated as substantial numbers of outbreaks are being recorded this year."

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Norovirus infection, well known as the "stomach flu," is the most common cause of acute gastroenteritis, afflicting 23 million Americans annually. Norovirus infection is characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea, and occasionally fever. Dehydration is the most common complication, particularly in the elderly, young and hospitalized populations. Severe clinical outcomes are associated with these at-risk populations, where infection can disrupt primary treatment regimens and, in severe cases, can lead to death.

Noroviruses are highly infective, easily transmitted, and difficult to kill. Extensive outbreaks occur in community environments, particularly hospitals, hotels, schools, and nursing homes, resulting in mounting socioeconomic cost to businesses dealing with epidemic outbreaks. The military is also affected, as outbreaks represent a significant readiness issue for naval vessels and land-based military installations.

LigoCyte's Norovirus vaccine is a needle-free, dry powder formulation based upon virus like particles which are highly purified protein products. By preserving the authentic conformation of the viral capsid, VLPs mimic the functional interactions of the live virus, while lacking the ability to reproduce or cause illness. LigoCyte's vaccine formulation also includes the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline and chitosan under license from Archimedes Pharma, to enhance nasal delivery.

On April 27, 2007, Dr. Charles Richardson, executive VP, research & development at LigoCyte, will present data on the Norovirus vaccine at the 4th International Conference on Vaccines for Enteric Diseases in Lisbon, Portugal. Dr. Richardson's oral presentation will include preclinical data showing humoral, cellular, and mucosally-derived immunogenicity; safety results from the recently completed toxicology study, including data on serum immunoglobin levels; and the clinical trial design for the Phase I human safety study.

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