By Zhihong Xu (auth.), Zhihong Xu, Jiayang Li, Yongbiao Xue, Weicai Yang (eds.)
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Additional resources for Biotechnology and Sustainable Agriculture 2006 and Beyond: Proceedings of the 11th IAPTC&B Congress, August 31-18, 2006 Beijing, China
Of 33 participants given either two or three 1-mg doses of the antigen, about half showed increased serum IgG titers against the virus. Facing the Future with Pharmaceuticals from Plants 21 Finally, Yusibov et al. (2002) have carried out a trial involving 14 volunteers given spinach infected with alfalfa mosaic virus vectors expressing the rabies virus glycoprotein and nucleoprotein. Five of these individuals had previously received a conventional rabies vaccine. Three of those five and all nine of the initially naïve subjects produced antibodies against rabies virus while no such response was seen in those given normal spinach.
What is exciting about this application is that because insulin is a simple protein with extensive clinical safety and efficacy data, the company expects that regulatory approval of plant-derived insulin will be based on abbreviated clinical trial protocols once its purity and bioequivalence of commercial insulin (produced in bacteria) has been established. This could mean the product reaches the market as early as 2009 and may therefore be among the first PDPs to see commercial release. SemBioSys estimates that the whole world’s demand for insulin could be 22 R.
A veterinary vaccine was the first PDP to be approved, in February 2006, and there is a large body of both immunogenicity and challenge data to support the efficacy of such vaccines. In a number of reports, plant-derived recombinant subunit vaccines have protected animals against (in some cases lethal) challenges with the pathogen. , a former biopharmaceutical company based in College Station, TX, have shown that an oral vaccine expressed in plants gives protection against a virulent viral pathogen in livestock.