Navigation Links
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 this highly contagious virus."

LigoCyte plans to enroll 98 subjects in the study across three cohorts. Initial study sites are the University of Rochester and Saint Louis University.  

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. 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. Severe clinical outcomes are associated with particular at-risk populations, where complications caused by infection can disrupt primary treatment regimens and even lead to death.

LigoCyte's norovirus vaccine franchise is based on VLP antigens, which are highly purified protein products.  By preserving the authentic conformation of the viral capsid, VLPs mimic the antigens as they exist on the live virus while lacking the ability to reproduce or cause illness.  LigoCyte's vaccine formulations also include the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline (NYSE: GSK).  Additional information about the study can be found at www.clinicaltrials.gov.

About LigoCyte

LigoCyte is a private, clinical-stage biopharmaceutical company focused on developing novel vaccines for gastrointestinal and respiratory indications. LigoCyte's expertise in virus-like particle technology supports a pipeline of enhanced product candidates, including vaccines against norovirus, influenza and respiratory syncytial virus. LigoCyte has funded its product development efforts through a mix of private investment as well as grants and contracts administered through the National Institutes of Health and the U.S. Department of Defense, including a recent $3.6 million commitment from the agency. LigoCyte's investors include Forward Ventures, JAFCO, Novartis Venture Fund, Fidelity Biosciences, MedImmune Ventures, Athenian Venture Partners and MC Life Sciences Ventures (Mitsubishi International Corporation). The company closed its most recent financing in April 2010 from its existing venture investors. GlaxoSmithKline is also a shareholder of the company. For additional information on LigoCyte, please visit www.ligocyte.com.


'/>"/>
SOURCE LigoCyte Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. LigoCyte Pharmaceuticals Announces Collaboration With Biogen Idec to Develop Anti-CD103 Therapies
2. LigoCyte Pharmaceuticals Initiates a Randomized, Double Blind, Placebo Controlled Norovirus Vaccine Study Including Live Virus Challenge
3. Data From LigoCytes Clinical Studies of Norovirus VLP Vaccine Presented at 13th Annual Conference on Vaccine Research
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
6. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
7. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
8. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
9. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
10. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
11. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, ... 8th Day Software and Consulting, LLC , and named ... 8th Day Software, based in Tennessee , ... 8th Day expands EnvoyHealth,s service offerings for health care ... "In an interoperable ...
(Date:9/28/2017)... 28, 2017 Hill-Rom Holdings, Inc. (NYSE: HRC), ... call and webcast on Friday, November 3, 2017, beginning ... ending at approximately 8:30 a.m. (CDT) / 9:30 a.m. ... 2017 financial performance and guidance for 2018, Hill-Rom executives ... enhance operational performance, and long-range financial outlook through 2020. ...
(Date:9/25/2017)... 25, 2017  EpiVax, Inc., a leader in ... immune-engineering today announced the launch of EpiVax Oncology ... personalized therapeutic cancer vaccines. EpiVax has provided $500,000 ... to enabling technologies to the new precision immunotherapy ... EpiVax Oncology as Chief Executive Officer. Gad brings ...
Breaking Medicine Technology:
(Date:10/13/2017)... , ... October 13, 2017 , ... The Visiting Nurse ... Market. Featuring a collection of specialty vendors and unique items from across the nation, ... quality-focused health and wellness services offered by the VNA. The boutique will be ...
(Date:10/13/2017)... Abilene, Texas (PRWEB) , ... October 13, 2017 , ... ... publication this week that explains one of the most popular and least understood books ... seems like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a ... “The Journey: From the Mountains to the Mission Field” is the creation of published ... all ages and currently teaches a class of ladies at her church, which she ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 ... characterized by frequent cessation in breathing. Oral appliances can offer significant relief to ...
(Date:10/12/2017)... , ... October 12, 2017 , ... IsoComforter, Inc. ( ... announced today the introduction of an innovative new design of the shoulder pad. ... you get maximum comfort while controlling your pain while using cold therapy. By utilizing ...
Breaking Medicine News(10 mins):