According to the U.K.'s Daily Telegraph, Bavarian Nordic's therapeutic prostate cancer vaccine, PROSTVAC, has started a Phase III trial in the U.K. This is part of its ongoing PROSPECT trial in men with asymptomatic or minimally symptomatic castration-resistant prostate cancer.
The poxvirus-based vaccine includes the DNA sequence for a section of the prostate-specific antigen (PSA), which is increased in prostate cancer, but Bavarian Nordic's version has a slight change to improve the immune reaction. It is given monthly just under the skin. According to the Telegraph, this is the first cancer vaccine to have made it to Phase III in Europe.
Treatment of castration-resistant prostate cancer (previously known as "hormone refractory") often extends life by only a few months and can include side effects. In Phase II trials, PROSTVAC increased survival by around 8.5 months. Bavarian Nordic president Dr. Reiner Laus told the Telegraph that the vaccine would have far milder side effects than existing treatments like chemotherapy and would hopefully be licensed by 2015.
This trial needed approval from the U.K's Department for Environment, Food and Rural Affairs (Defra) Advisory Committee on Releases to the Environment (ACRE) because it involves use of a genetically modified organism, and this was given in January.
- check out the article in the U.K. Daily Telegraph
- see the minutes from the ACRE meeting