For Immediate Release July 7, 1999
Deborah Pettibone
(716) 845-8593
[email protected]
HUMAN TRIALS FOR ORAL HEPATITIS B PLANT VACCINE BEGIN AT ROSWELL PARK CANCER INSTITUTE
BUFFALO, NY, and ITHACA, NY, USA - Roswell Park Cancer Institute (RPCI), Buffalo, NY, and the Boyce Thompson Institute (BTI) at Cornell University, Ithaca, NY, announced that clinical trials will begin today, Wednesday, July 7, 1999, at RPCI, to test the safety and immunogenicity of the world's first potential oral vaccine against the hepatitis B virus. The vaccine will be delivered by simply eating potatoes genetically designed to contain the vaccine.
More than two billion people worldwide are affected by the hepatitis B virus, a leading cause of liver cancer and the cause of more than one million deaths annually.
This trial is the culmination of several years of collaborative preclinical work by Yasmin Thanavala, PhD, Department of Immunology at RPCI, and Charles Arntzen, PhD, and Hugh Mason, PhD, at BTI. This program was funded primarily by the National Institutes of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH) in the United States.
In this placebo-controlled, double-blind, Phase I study, healthcare workers who previously responded to a licensed, injectable vaccine will receive an oral booster dose.
This dose will be delivered by a sample of transgenic potato that expresses the hepatitis B surface antigen.
Conducted at RPCI, the clinical trial will be jointly coordinated by immunologist Dr. Thanavala and Martin Mahoney, MD, PhD, director of the Employee Health Clinic and a 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 this study.
"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 Dr. Thanavala. "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," said Dr. Mahoney.
BTI generated the potatoes for the clinical trial with financial support provided by Axis Genetics, plc, of Cambridge, UK. Axis Genetics successfully had its Investigational New Drug (IND) application for this clinical trial approved by the U.S.Food and Drug Administration in May, 1999. "A current vaccine is available to prevent hepatitis B," said Dr. Charles Arntzen, president and CEO of BTI. "It is very effective. However, cost and the 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."
Boyce Thompson Institute for Plant Research, Inc., was founded in 1924 in Yonkers, NY, 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.
Roswell Park Cancer Institute was founded in 1898, is the nation's first and one of its largest cancer research, treatment and education centers and is the only National Cancer Institute-designated comprehensive cancer center in Western New York.
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For further information on Roswell Park Cancer Institute, or for an interview with Dr. Yasmin Thanavala or Dr. Martin Mahoney, please call Deb Pettibone at (716) 845-8593, fax (716) 845-8362 or e-mail [email protected]. You can also visit the RPCI website at www.roswellpark.org.
For further information on Boyce Thompson Institute for Plant Research, or for an interview with Dr. Charles Arntzen, please call (607)-254-1301 or Joyce Frank, vice president for Licensing and Development at (607) 254-1220. You can also visit the BTI website at http://bti.cornell.edu
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