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LigoCyte Pharmaceuticals Initiates First Clinical Trial for Bivalent Intramuscular Norovirus Vaccine
Date:9/16/2010

BOZEMAN, Mont., Sept. 16 /PRNewswire/ -- LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company focused on the development of innovative vaccine products, announced today that it has initiated the first clinical trial for its bivalent intramuscular (IM) norovirus vaccine candidate, marking the fourth human clinical trial in the Company's norovirus virus-like particle (VLP) vaccine program.  The Phase I dose-escalation study will assess safety and immunogenicity associated with an IM formulation of LigoCyte's investigational vaccine in healthy adults. Clinical studies to date have shown a nasal formulation of a monovalent norovirus VLP vaccine to be immunogenic (i.e., having the ability to create an immune response) and generally well tolerated.

The bivalent vaccine formulation involved in the trial includes antigens from both norovirus genogroups that commonly infect humans. LigoCyte's bivalent vaccine is designed to provide protection against group I noroviruses with its GI.1 VLP antigen and against group II noroviruses with its GII.4 VLP antigen. Genogroup II.4 noroviruses are responsible for the majority of norovirus disease worldwide.  

"Norovirus infections are recognized as a widespread problem that can have very serious consequences," said Donald P. Beeman, CEO of LigoCyte.  "This bivalent norovirus vaccine is the first to be tested clinically, and the first GII.4 subtype antigen to be included in a human vaccine. Study of an intramuscular norovirus vaccine will continue to advance our norovirus program, which has been built on a nasally administered dry powder formulation. We have shown excellent results with the nasal vaccine to date, and investigation of multiple routes of administration will help us to select the best possible form of the product to prevent the burden of disease associated with
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SOURCE LigoCyte Pharmaceuticals, Inc.
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