Boyce Thompson-developed oral plant vaccine receiving first human trials for
hepatitis B at Roswell Park
FOR RELEASE: July 7, 1999
Contact: Joyce L. Frank
Office: (607) 254-1220
E-Mail: jf51@cornell.edu
ITHACA, N.Y. -- The Boyce Thompson Institute for Plant Research Inc. (BTI), an
affiliate of Cornell University, announced that clinical trials will begin today
(July 7) at Roswell Park Cancer Institute (RPCI) in Buffalo, N.Y., to test the
safety and immunogenicity of the world's first potential oral vaccine against
the hepatitis B virus. The vaccine will be delivered simply by eating potatoes
genetically designed to contain the vaccine.
More than 2 billion people worldwide
are affected by the hepatitis B virus, a leading cause of liver cancer and the
cause of more than 1 million deaths annually.
This trial is the culmination of several years of collaborative preclinical
work by Charles Arntzen, president and chief executive of BTI, and Hugh Mason, a
BTI researcher, and by Yasmin Thanavala, Department of Immunology at RPCI. The
program is funded by the National Institute of Allergy and Infectious Diseases,
part of the National Institutes of Health (NIH).
In the placebo-controlled, double-blind, phase I study, health-care workers
who previously responded to a licensed, injectable vaccine will receive an oral
booster dose. The dose will be delivered by the consumption of a sample of
transgenic potato that expresses the hepatitis B surface antigen.
The clinical trial will be jointly coordinated by Thanavala and Dr. Martin
Mahoney, director of the RPCI Employee Health Clinic and member of the
Department of Cancer Prevention, Epidemiology & Biostatistics. They will share
responsibility for the conduct of the laboratory testing and clinical
assessment, respectively, for the study.
BTI generated the potatoes for the clinical trial with financial support from
Axis Genetics of Cambridge, England. "A current vaccine is available to prevent
hepatitis B. It is very effective," said Arntzen. "However, cost and
inconvenience of needles have limited its acceptance in many countries.
"Alternatives to injectable vaccines are needed if we are to seriously
consider global eradication of this disease. An oral vaccine would also increase
its acceptance in this country."
Thanavala noted, "We are very pleased to be taking the next logical step with
this research. The continued support of my basic research by the NIH and the
World Health Organization, along with the recent collaboration with Axis
Genetics, offers us a novel way to impact public health and control hepatitis B
worldwide."
Said Mahoney, "This project is a wonderful example of moving research ideas
from the laboratory bench to the bedside. We are pleased to participate in this
trial to bring this vaccine into a clinical setting."
BTI was founded in 1924 in Yonkers, N.Y., and moved to Ithaca in 1978,
affiliating with Cornell University. BTI strives to improve human health and
well-being and conserve the natural environment through plant research. Its
comprehensive research areas include an emphasis on plants for human health.
RPCI, founded in 1898, is the nation's first and one of its largest cancer
research, treatment and education centers. It is the only National Cancer
Institute-designated comprehensive cancer center in western New York. For
further information on RPCI, or to request interviews with Thanavala or Dr.
Mahoney, call Deb Pettibone at (716) 845-8593 or fax, (716) 845-8362, or e-mail
pettibone@sc3101.med.buffalo.edu.
Related World Wide Web sites: The following sites provide additional
information on this news release. Some might not be part of the Cornell
University community, and Cornell has no control over their content or
availability.
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.
"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"
