Navigation Links
The New England Journal of Medicine Publishes Study Showing LigoCyte's Norovirus Vaccine Demonstrates Protection Against Illness

BOZEMAN, Mont., Dec. 8, 2011 /PRNewswire/ -- LigoCyte Pharmaceuticals, Inc. announced today that its experimental vaccine provided significant protection against norovirus infection and related gastrointestinal illness collectively known as acute gastroenteritis (AGE). Norovirus infection, sometimes referred to as "the stomach flu" is one of the most common causes of severe nausea, vomiting, abdominal cramps and diarrhea afflicting 21 million Americans annually and is an important contributor to gastrointestinal disease worldwide. This was the first time a vaccine has demonstrated protection against norovirus. No commercially available vaccines or specific therapies currently exist to prevent or treat norovirus infection. The results of the Phase I/II study, conducted with a virus-like particle (VLP) vaccine, were published today in The New England Journal of Medicine. This study was a multi-center trial performed in collaboration with a consortium including Baylor College of Medicine, Cincinnati Children's Hospital, Johns Hopkins University, SNBL CPC, Inc., University of Maryland and The EMMES Corporation.


"This is the first demonstration of protection in humans against what is a widespread and often serious illness and is a big development for the field," said Robert Atmar, M.D., of Baylor College of Medicine and the study's principal investigator. "The number of hospitalizations and the healthcare costs associated with norovirus are staggering; a successful vaccine against norovirus would offer significant protection to patients as well as potential cost reductions for the healthcare system." Click here for a video interview with Dr. Atmar from Baylor College of Medicine.

"The positive results from this rigorous challenge study demonstrate that norovirus gastroenteritis, which can result in severe illness in many people, can be prevented by vaccination," said Donald P. Beeman, LigoCyte's Chief Executive Officer. "We look forward to the results of upcoming clinical studies of the product."

Specifically, data from the study show:

  • In the 77 adults who completed the trial per its original protocol, vaccination decreased the incidence of gastroenteritis due to norovirus from 69.2 percent to 36.8 percent, a 47 percent reduction in illness compared to subjects receiving placebo (95% CI 15.2%-66.6%; p=.006).
  • Subjects receiving vaccine scored lower on a severity of illness scale (p=.011).
  • Immunization with the VLP vaccine increased antibody titers that blocked VLP binding to histo blood group antigens in vitro.
  • Higher functional antibody responses in all subjects correlated with increased protection against illness. A serum BT50 titer of 200 or greater was associated with a 72.2 percent reduction in virus-associated illness (odds ratio of 8.1 (95% CI 2.1-31.2)).
  • Adverse events occurred with similar frequency among vaccine and placebo subjects. The most common symptoms after vaccination included nasal congestion, stuffiness and sneezing.

About Norovirus Illness

Norovirus gastroenteritis is a widespread and potentially severe illness characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea and occasionally fever. Noroviruses are highly infective and easily transmitted from person to person or via contaminated environments. Epidemic outbreaks occur in community environments, particularly hospitals, hotels, schools, day care facilities and nursing homes, with mounting socioeconomic cost to families, the health care system and businesses. Military units are significantly affected when the virus strikes, as outbreaks impact combat readiness. Severe clinical outcomes are reported in older adults, children and immunocompromised individuals in whom infection can lead to substantial complications and can even lead to death.

About the Phase I/II Norovirus Vaccine and Challenge Study

The Phase I/II randomized, double blind, multi-center, placebo-controlled safety and efficacy study was designed to evaluate the norovirus monovalent GI.1 VLP vaccine versus placebo in healthy adult volunteers between the ages of 18 and 50 years. The study consisted of two stages: the vaccination stage with post-vaccination follow-up, followed by the challenge stage, in which subjects were exposed to the live virus, with post-challenge follow-up. Subjects received a two-dose intranasal regimen of either the vaccine or placebo on days 0 and 21 and were evaluated for vaccine safety and immune responses. On or after study day 42, subjects were admitted to an inpatient nursing unit, challenged with live norovirus, held in the unit for at least four days following challenge and then followed for post-challenge safety and efficacy with multiple clinical assessments and collection of stool specimens. The study was conducted at Baylor College of Medicine, the University of Cincinnati and Cincinnati Children's Hospital Medical Center, the Johns Hopkins School of Medicine and SNBL CPC, Inc., a clinical research organization in Baltimore, Md.

About LigoCyte's Norovirus Vaccine Candidate

LigoCyte's norovirus vaccine contains virus-like particle (VLP) antigens representing the live virus while lacking the ability to reproduce or cause illness. VLPs mimic the natural virus by preserving the authentic structure of the viral capsid, the shell of protein that protects the nucleic acid of a virus. LigoCyte's VLP technology enables the production of vaccines that are designed to cover multiple genetic varieties (or 'strains') of norovirus. LigoCyte's vaccine formulation also includes the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline PLC (NYSE: GSK), and the nasal vaccine incorporates chitosan. This application of chitosan (ChiSys®) has been licensed from Archimedes Development Ltd.(1)

A clinical study of a multi-strain (bivalent) formulation of LigoCyte's norovirus vaccine is ongoing. Preliminary results from that study were presented by one of the principal investigators in the study, Sharon Frey, M.D., from the Saint Louis University Center for Vaccine Development at the Saint Louis University School of Medicine, at the Infectious Diseases Society of America (IDSA) 2011 Annual Meeting on October 21 in Boston, Mass. Data presented at the meeting indicate that the bivalent vaccine induces immune responses that are even more potent than the single strain (monovalent) vaccine.

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, respiratory syncytial virus and rotavirus. 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. 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). GlaxoSmithKline is also a shareholder of the company. For additional information on LigoCyte, please visit

(1) ChiSys is a trademark of Archimedes Development Ltd., and is registered as a CTM, as a U.S. Registered Trademark and in certain other jurisdictions.


SOURCE LigoCyte Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Bellicum Announces Publication in The New England Journal of Medicine Demonstrating Complete Reversal of Serious Immune Condition in Hematopoietic Stem Cell Transplant Patients
2. NxStage: NIH Study Published in New England Journal of Medicine Adds to Growing Body of Evidence in Support of More Frequent Hemodialysis
3. New Study Published in New England Journal of Medicine Shows Investigational BIBF 1120 Demonstrated Positive Trend in Reducing Lung Function Loss in Idiopathic Pulmonary Fibrosis
4. Fuse Science Partners With the New England Consulting Group to Advance Technology Licensing Efforts in Pharmaceutical and OTC Categories
5. New Phase 2 Data Published in New England Journal of Medicine Show Bardoxolone Methyl Sustained Improvement in Measure of Kidney Function (eGFR) Over 52 Weeks in Patients With Moderate to Severe Chronic Kidney Disease and Type 2 Diabetes
6. NxStage Founder and CEO Jeffrey Burbank Named Ernst & Young Entrepreneur of the Year® 2011 New England Award Winner
7. Pivotal Phase 3 Study Published in The New England Journal of Medicine (NEJM) Finds Overall Survival of Patients with Metastatic Castration-Resistant Prostate Cancer is Significantly Improved with ZYTIGA™ (abiraterone acetate)
8. New England Biolabs Expands its Distribution Network through Collaborations in India and the Netherlands
9. River Valley Community College and Medical Messenger Team Up to Prepare the Future Nurses of New England
10. Technology Collaboration Between New England Biolabs and Sequenom Delivers First Product for Epigenetics
11. Hospitalists at New England Baptist Hospital Choose MedAptus
Post Your Comments:
(Date:11/24/2015)... BOULDER, Colo. , Nov. 24, 2015 /PRNewswire/ ... announced that its Chief Executive Officer, Ron ... Annual Healthcare Conference in New York.  The public ... a webcast on the Array BioPharma website.Event:Piper Jaffray ... OfficerDate:  , Wednesday, December 2, 2015Time:1:30 p.m. Eastern ...
(Date:11/24/2015)... New York , 24. November 2015 ... des Avery Breathing Pacemaker Systems, ist erfreut, ... als Clinical Consultant bekannt geben zu können. ...   --> Foto ... Stockholm (Schweden). Von 1984-1986 war ...
(Date:11/24/2015)... 24, 2015 Avery Biomedical Devices (ABD), manufacturer ... announce the appointment of Anders Jonzon , MD; ... Dr. Jonzon is a Physiologist ... Hospital, Uppsala University, Uppsala and Children,s Hospital, Karolinska, ... a fellow at the Cardiovascular Institute (UCSF). His research ...
Breaking Medicine Technology:
(Date:11/25/2015)... Nairobi (PRWEB) , ... November 26, 2015 , ... ... African Union Commission (AUC), European Union (EU), ANDI Pan African Centres of Excellence, ... Nations Office in Nairobi (UNON) for the opening of the 5th African Network ...
(Date:11/25/2015)... ... November 25, 2015 , ... Lakeview Health, a Jacksonville-based ... celebrate their sobriety and show through pictures what a positive difference it makes. ... Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, Twitter, and Instagram accounts. ...
(Date:11/25/2015)... Crystal Lake, IL (PRWEB) , ... November 25, 2015 , ... ... pleased to announce a recent successful appellate decision obtained by Attorneys Francisco J. Botto ... the case Adcock v. Illinois Workers’ Compensation Comm’n, 2015 IL App (2d) 130884WC. , ...
(Date:11/25/2015)... ... , ... Beddit® has launched a new Android app for use ... a more intuitive SleepScore™ that rates sleep quality on a 100-point scale and makes ... by a proprietary algorithm. Beddit analyzes the data to provide an easy to understand ...
(Date:11/25/2015)... ... November 25, 2015 , ... Today, Mothers Against Drunk Driving ... dropped below 10,000 for the first time since 2011. In 2014, there were 9,967 ... data released by the National Highway Traffic Safety Administration (NHTSA), 32,675 people were killed ...
Breaking Medicine News(10 mins):