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Oxford, UK – 10 October 2012: Oxford BioMedica (“Oxford BioMedica” or “the Company”) (LSE: Oxford Biomedica), the leading gene-based biopharmaceutical company, today announces that it plans to close the Phase II study in the United States (US) 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 programme in other indications led by academic collaborators in the UK.
As previously announced, Oxford BioMedica initiated a randomised, open-label Phase II study in patients with metastatic HRPC in September 2010. Since then, the prostate cancer treatment landscape in the US 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:
- Importantly, these data validate the observation that Oxford BioMedica’s pre-treatment biomarker1 can identify patients most likely to benefit from treatment with TroVax®:
- A trend towards increased time to disease progression in patients who received TroVax® plus chemotherapy drug docetaxel versus those who received docetaxel alone;
- As with prior studies, HRPC patients with a favourable biomarker profile mounted stronger 5T4 immune responses; and
- Furthermore, the biomarker score was associated with the time to disease progression in patients treated with TroVax® plus docetaxel.
1. Oxford BioMedica’s algorithm biomarker is a combination of three pre-treatment blood parameters: 5T4 antibody levels; haemoglobin; and haematocrit (the proportion of blood volume occupied by red blood cells) which can all be measured using a simple blood test.
Verified data from this study will be presented at the first Immunotherapies & Cancer Vaccines conference from 5-6 December, 2012 in Brussels, Belgium.
Future Phase II development
In July 2012, Oxford BioMedica’s partners at Cardiff University, Wales (UK) 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. Securing a development or financial partner for TroVax®’s future late-stage development remains a key strategic priority for the Company and discussions with interested parties are ongoing.
John Dawson, Chief Executive Officer of Oxford BioMedica, 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.”
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