BioMedica Stops TroVax Trials in US
Oxford BioMedica has announced that they have halted their mid-stage trials of TroVax in America.
The organisation confirmed that they would be stopping the US portion of trials to evaluate the activity of TroVax (MVA-5T4) in patients with progressive hormone refractory prostate cancer (HRPC). The market didn’t respond well, with BioMedica’s share price falling by 9% yesterday.
The medication, which operates as an immunotherapy against cancer, will continue Phase II development programme in other indications around the world, and will now be exclusively led by UK academic collaborators.
The business started the open-label, Phase II study in patients with metastatic HRPC in September 2010. Since then, the prostate cancer treatment setting in America has changed, with new products available and other clinical trials targeting the same indication, Oxford BioMedica commented.
These products include rival Denderon’s prostate cancer vaccine Provenge, and Johnson & Johnson’s pill Zytiga, which have both received US FDA approval in the past two years. This means that competition for BioMedics’s drug, which is still a while off any potential regulatory approval, has increased substantially.
The company have also acknowledged that competition for suitable patients with HRPC ‘has been high’ and recruitment into the clinical study has been much slower than originally expected, with only 26 patients recruited to date.
This has not been the first time the drug has encountered problems. In 2009, TroVax failed to meet its primary endpoint in Phase III trials, with the Data Safety Monitoring Board stating that overall survival improvement would not be increased.
As a result of the failure, the business decided to go back to mid-stage trials, and focus on the prostate cancer licence, but this week’s news will be another setback for the company.