Oxford BioMedica to close US trial of TroVax due to "changing landscape"

UK gene-based biopharma company Oxford BioMedica (LSE: OXB) says that it plans to close the Phase II study in the USA to assess the activity of TroVax (MVA-5T4) in patients with progressive hormone refractory prostate cancer (HRPC). TroVax continues to have an active Phase II development program in other indications led by academic collaborators in the UK.

As previously announced, Oxford BioMedica initiated a randomized, open-label Phase II study in patients with metastatic HRPC in September 2010. Since then, the prostate cancer treatment landscape in the USA has changed with new products available and other clinical trials targeting the same indication. As such, competition for suitable patients with HRPC has been high and recruitment into the study has been much slower than originally anticipated with 26 patients recruited to date. Whilst early data from this study are encouraging, the board has made a strategic decision to close the US trial in order to focus on investigator-led Phase II studies, currently in the UK.

Encouraging preliminary data

Although the study will close prior to completion of patient recruitment, and therefore any unverified preliminary data should be interpreted with caution, initial data indicate:
• a trend towards increased time to disease progression in patients who received TroVax plus chemotherapy drug docetaxel versus those who received docetaxel alone;
• importantly, these data validate the observation that Oxford BioMedica’s pre-treatment biomarker1 can identify patients most likely to benefit from treatment with TroVax: