BOZEMAN, Mont., April 3 /PRNewswire/ -- 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."
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 (VLPs), 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 (NYSE: GSK), and chitosan (ChiSys(R)), 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 (VED2007) 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 (IgG) immunoglobin levels; and the clinical
trial design for the Phase I human safety study.
About LigoCyte:
LigoCyte, established in 1998, is developing a new generation of
vaccines and monoclonal antibody therapeutics for the prevention and
treatment of infectious diseases and inflammation. LigoCyte is advancing
its proprietary products into human clinical testing, positioning the
company for continued growth and success in the biotechnology industry. For
additional information on LigoCyte, please visit http://www.ligocyte.com. Binding
Science. Better Medicine.
ChiSys(R) is a trade mark of Archimedes and is registered as a CTM, and
as a US Registered Trademark and in certain other jurisdictions.
This work is supported by the U.S. Army Medical Research and Material
Command under Contract Nos. DAMD17-01-C-0040 and W8IXWH-05-C-0135. The
views, opinions and/or findings contained in this report are those of the
author(s) and should not be construed as an official Department of the Army
position, policy or decision unless so designated by other documentation.
In conducting research using animals, the investigator(s) adhered to the
"Guide for the Care and Use of Laboratory Animals," prepared by the
Committee on Care and Use of Laboratory Animals of the Institute of
Laboratory Animal Resources, National Research Council (NIH Publication No.
86-23, Revised 1985).
SOURCE LigoCyte Pharmaceuticals, Inc.
 back to top
Related links:
http://www.ligocyte.com
CONTACT:
Karen Sipes, Ph.D., Director, Marketing &
Communications of LigoCyte Pharmaceuticals, Inc.,
+1-406-556-9228, karen.sipes@ligocyte.com
|
