Oxford BioMedica plans to halt its Phase II study on its cancer vaccine TroVax in the US over recruitment issues and competition in the market.
The gene-based biopharmaceutical company said it plans to stop the trial to assess the activity of TroVax in patients with progressive hormone refractory prostate cancer.
An open-label Phase II study on the drug began in September 2010 but since then, the prostate cancer treatment landscape in the US has changed, with new products available and other trials targeting the same indication, BioMedica said in a statement.
These products include Johnson & Johnson’s Zytiga and Denderon’s prostate cancer vaccine Provenge.
Due to competition for suitable patients, recruitment into the study has been much slower than BioMedica anticipated, with 26 patients recruited to date.
The board of directors has therefore decided to close the trial in order to focus on investigator-led Phase II studies, currently in the UK.
In July 2012, BioMedica’s partners at Cardiff University, Wales initiated a Phase II trial to assess the safety and immunological activity of TroVax in patients with inoperable metastatic colorectal cancer.
The company expects two further investigator-led Phase II studies in mesothelioma and ovarian cancer to be initiated in the UK by academic collaborators in Q4 2012.
It now hopes to secure a financial partner for late-stage development of the drug.
Company CEO John Dawson said: "Whilst changes to the treatment landscape in the US have challenged recruitment into our prostate cancer trial, early data support the use of our biomarker which is an important step in the ongoing clinical development of TroVax.
"We are focused on our Phase II programme with academic collaborators in the UK which will further support the potential for TroVax in the treatment of multiple cancer indications."
Image: No cancer vaccines have been proven to cure cancer or extend life yet. Photo: courtesy of FreeDigitalPhotos.net.