LigoCyte Pharmaceuticals, Inc. Initiates a Randomized, Double Blind, Placebo Controlled Norovirus Vaccine Study Including Live Virus Challenge
Published: Sep 08, 2009
BOZEMAN, Mont., Sept 8 /PRNewswire/ -- LigoCyte Pharmaceuticals, Inc. announced today that it has initiated its third human clinical trial of its norovirus vaccine. The Phase I/II study will assess safety and immunogenicity associated with LigoCyte's investigational, nasally-delivered, dry powder vaccine in healthy adults. The study will also assess potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo. Clinical studies to date have shown the vaccine to be immunogenic and generally well tolerated in human subjects.
Norovirus infection, well known as the "stomach flu," is the most common cause of acute gastroenteritis, afflicting nearly 23 million Americans annually. Norovirus infection is characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea, and occasionally fever. Severe clinical outcomes are associated with at-risk populations, where complications caused by infection can disrupt primary treatment regimens and even lead to death. Noroviruses are highly infective and easily transmitted. Epidemic outbreaks occur in community environments, particularly hospitals, hotels, schools, and nursing homes, resulting in significant risk to immunocompromised individuals and mounting socioeconomic cost to families, the health care system and businesses. Military units are also affected, as outbreaks represent a significant readiness issue for naval vessels and land-based installations.
On September 9, 2009, Marcelo Sztein, M.D., Professor of Pediatrics and Medicine at the Center for Vaccine Development at the University of Maryland School of Medicine, will present safety and immunogenicity data on LigoCyte's norovirus vaccine at the 5th International Conference on Vaccines for Enteric Diseases (VED2009) in Malaga, Spain. Dr. Sztein's oral presentation will include clinical data on safety of the vaccine as well as serum immunoglobulin levels (IgG and IgA) resulting from vaccination.
LigoCyte is an immunology company developing a new generation of vaccines for the prevention of infectious diseases. LigoCyte's expertise in virus-like particle vaccines supports a pipeline of enhanced products, including vaccines against norovirus, influenza and respiratory syncytial virus. The company is also developing antibody therapeutics against important chronic inflammatory diseases. For additional information on LigoCyte, please visit www.ligocyte.com.
SOURCE LigoCyte Pharmaceuticals, Inc.
CONTACT: James Grenzebach of LigoCyte Pharmaceuticals, Inc.,
Web site: http://www.ligocyte.com/