LigoCyte Pharmaceuticals Initiates U.S. Clinical Trial of Norovirus Vaccine that Incorporates Virus-like Particle Technology Licensed from Baylor College of Medicine
Bozeman, Montana and Houston, Texas - April 3, 2007 - LigoCyte Pharmaceuticals, Inc. announced on April 3, 2007, 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.
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 entered into an exclusive license agreement with Baylor College of Medicine in 2004 for rights to intellectual property and technology related to the use of norovirus VLPs as a vaccine. The licensed IP and technology was developed in the Baylor laboratory of Dr. Mary Estes , a well-known expert in the field of viral gastroenteritis. “I am delighted to hear that LigoCyte has initiated their Phase I clinical trial," said Dr. Estes, a Professor in the Department of Molecular Virology and Microbiology. "This is a significant milestone for them, and represents an important advance in the development of a VLP-based vaccine that has the potential to prevent norovirus-associated disease. We are very pleased to be working with LigoCyte because industry collaborations of this nature can provide an important mechanism to accelerate the clinical development of discoveries made here at Baylor."
LigoCyte's vaccine formulation also includes the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline, and chitosan (ChiSys® ), under license from Archimedes Pharma, to enhance nasal delivery.
"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.
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 www.ligocyte.com . Binding Science. Better Medicine.
About Baylor College of Medicine :
Baylor College of Medicine in Houston , Texas , the only private medical school in the Greater Southwest, was founded in 1900 and is today an internationally respected medical and research institution known for excellence in education, research and patient care. Today, the College consistently ranks among the country's top 125 medical schools. For 2006, U.S. News & World Report has again ranked the College No. 13 on its list of top medical schools. BCM also is listed 11th among all U.S. medical schools for National Institutes of Health funding, and No. 1 for research expenditures in biological science by the National Science Foundation. Located in the Texas Medical Center , a 700-acre complex housing 42 member institutions, BCM has affiliations with seven teaching hospitals, each with a national and international reputation for medical excellence. The College has total research support exceeding $401.5 million, with $340 million from federal sources, and more than 90 research and patient-care centers and units. Currently, BCM trains more than 3,000 medical, graduate, nurse anesthesia, and physician assistant students, as well as residents and post-doctoral fellows. For more information, please visit: www.bcm.edu.