LONDON Axis Genetics plc has commissioned U.S. company Ag-Tec International Ltd., of Delevan, Wis., to grow potatoes containing hepatitis B vaccine for clinical trials due to start in 1999 at the Roswell Park Cancer Institute, in New York. In the trials, volunteers will be fed raw potato, but Axis intends to produce stable, orally available vaccines in pills, using existing food processing technologies.
The potatoes will be genetically engineered to express the hepatitis B surface antigen, plus an adjuvant. In animal studies, mice fed the potatoes produced hepatitis antibodies in the serum and in mucosal secretions.
Axis, based in Cambridge, wants to ensure that it can satisfy regulatory requirements. ¿By investing now, we will ensure compliance with production protocols demanded by the FDA and other regulatory authorities,¿ said Iain Cubitt, CEO of Axis. ¿We want to ensure that no procedure in the development chain holds back development of these novel vaccines.¿
Axis Genetics licensed the edible plant vaccine technology from the Boyce Thompson Institute, of Ithaca, New York, in May 1998. The two are also collaborating on vaccines for traveler¿s diarrhea and Norwalk virus infections. Nuala Moran