July 20, 2011
Pharming: Clinical Trials of Drugs from Genetically Engineered Plants
The use of genetically engineered plants or animals as factories for the production of desired proteins is a strategy with a relatilvely long shelf life in modern biotechnology. It's fair to say that the prospect of taking genes that encode therapeutically desirable proteins and putting them into bacteria, animals or plants for low-cost, high-output production was one of the first commercial applications of biotechnology that attracted investment. Clinical testing of these products continues to expand. "Pharming" is the term that has been applied to the use of plants or animals to generate new proteins from introdouced DNA. In 2009, the FDA issued the first approval for a drug produced from genetically engineered animals – the anticoagulaten Atryn produced in the milk of goats. The FDA has also approved the study of a tumor vaccine derived from genetically-manipulated (not engineered) tobacco plants, and clinical trials began in 2010. Now the UK has approved a clinical trial testing the use of an anti-HIV microbicide (a monoclonal antibody) for women that is produced from tobacco plants. This will be the first clinical trial in Europe for a therapeutic derived from genetically engineered plants.