Data From LigoCyte's Clinical Studies Of Norovirus VLP Vaccine Presented At 13th Annual Conference On Vaccine Research

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Infectious Diseases / Bacteria / Viruses;  Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 29 Apr 2010 - 2:00 PDT

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LigoCyte Pharmaceuticals, Inc., a private biopharmaceutical company focused on the development of innovative vaccine products, announced that results from two Phase I studies of its norovirus virus-like particle (VLP) vaccine candidate were presented at the 13th Annual Conference on Vaccine Research. Sponsored by the National Foundation of Infectious Diseases, the conference is being held in Bethesda, Maryland, from April 26-28, 2010.

Donald P. Beeman, Chief Executive Officer of LigoCyte, commented, "Each year, nearly 23 million Americans are infected with norovirus, the leading worldwide cause of infectious gastroenteritis, or inflammation of the stomach and intestines marked by acute vomiting and diarrhea. Epidemic outbreaks in hospitals, nursing homes and schools highlight this virus's significant burden, including serious and sometimes life-threatening complications.

"Given the urgency for prevention strategies, we are excited that Phase I data for LigoCyte's novel norovirus vaccine could be shared at NFID's Annual Conference on Vaccine Research."

Data presented during the conference were from two Phase I trials evaluating different dosage levels of the norovirus VLP vaccine candidate. The objective of the double-blind studies was to evaluate the vaccine's safety and immunogenicity in healthy volunteers, ages 18-49. Subjects were randomized to receive two doses of intranasal norovirus VLP vaccine (containing a Norwalk strain) or controls 21 days apart. The clinical results showed the vaccine to be immunogenic and generally well tolerated in human subjects. Local nasal symptoms, including for example nasal stuffiness, were common and generally brief. No vaccine-related serious adverse events occurred.

"This is a unique example of a vaccine against an enteric virus that was well tolerated and highly immunogenic when given intranasally. The vaccine activated immune cells with the capacity to migrate to the gastrointestinal tract and produce antibodies that have the potential to prevent infection," said Marcela F. Pasetti, Ph.D., Associate Professor of Pediatrics at the University of Maryland School of Medicine, who presented the data at the Vaccine Research Conference. Dr. Pasetti also is chief of the Applied Immunology Section at the University of Maryland Center for Vaccine Development.

The investigational, nasally delivered, dry powder vaccine is currently being examined in a Phase I/II study designed to assess safety and immunogenicity plus potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo. The company expects to release interim results for this study next quarter. In addition, the company expects to begin a Phase I trial with an intramuscular version of norovirus VLP vaccine before the end of 2010.

About Norovirus Infection

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.

About LigoCyte's Norovirus Vaccine Candidate

LigoCyte's norovirus vaccine is a needle-free, dry powder formulation based on virus-like particle (VLP) antigens, which are highly purified protein products. By preserving the authentic conformation of the viral capsid, VLPs mimic the antigen presentation 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®) to enhance nasal delivery, under license from Archimedes Development Ltd. LigoCyte's challenge study will utilize a live Norwalk virus inoculum developed at Baylor College of Medicine with funding from the National Institutes of Health.

About the Vaccine Research Conference

The Annual Conference on Vaccine Research provides current, high-quality reports of scientific progress featured in both invited presentations and submitted abstracts. The wide range of topics, covered in both human and veterinary vaccinology, offers a thorough picture of the opportunities, challenges and discoveries associated with vaccine development, production and distribution. The conference is sponsored by the National Foundation for Infectious Diseases (NFID) and held in collaboration with the Center for Biologics Evaluation and Research/Food and Drug Administration, Centers for Disease Control and Prevention, Center for Vaccine Development of the University of Maryland, Fondation Merieux, International Association for Biologicals, International Society for Vaccines, International Vaccine Institute, National Institute for Allergy and Infectious Diseases, The Jenner Society, Sabin Vaccine Institute and United States Department of Agriculture. Founded in 1973, NFID is a non-profit organization dedicated to educating the public and healthcare professionals about the causes, treatment and prevention of infectious diseases.

About LigoCyte

LigoCyte is a private, clinical-stage biotechnology 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.

The Phase I clinical studies were conducted with support from the U.S. Army Medical Research and Material Command under Contract No. W8IXWH-05-C-0135, from the University of Maryland General Clinical Research Center M00 RR 16500, GCRC Program, NCRR, NIH and from LigoCyte Pharmaceuticals, Inc. 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. The investigator(s) adhered to the policies regarding the protection of human subjects as prescribed by 45 CFR 36 and 32 CFR 219 (Protection of Human Subjects). Investigator(s) adhered to Guidelines for Research Involving Recombinant DNA Molecules; Notice, Federal Register, July 5, 1994, Volume 59, Number 127.

ChiSys® is a trade mark of Archimedes Development Ltd., and is registered as an EU Community Trademark, as a US Registered Trademark and in certain other jurisdictions.

Source: LigoCyte Pharmaceuticals, Inc

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