Oxford BioMedica Announces Update on TroVax® Development Strategy
Oxford, UK - 10 October 2012: Oxford BioMedica ("Oxford BioMedica" or "the Company") (LSE: OXB), 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:
· 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®:
- 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."
For further information, please contact:
Oxford BioMedica plc:
Lara Mott, Head of Corporate Communications
Tel: +44 (0)1865 783 000
Mary Clark/Sarah Macleod/Claire Dickinson
Tel: +44 (0)20 7920 2360
Notes to editors
1. Oxford BioMedica®
Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing innovative gene-based medicines and therapeutic vaccines that aim to improve the lives of patients with high unmet medical needs. The Company's technology platform includes a highly efficient LentiVector® gene delivery system, which has specific advantages for targeting diseases of the central nervous system and the eye; and a unique tumour antigen (5T4), which is an ideal target for anti-cancer therapy. Through in-house and collaborative research, Oxford BioMedica has a broad pipeline with current partners and licensees including Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, Emergent BioSolutions and ImaginAb. Further information is available at www.oxfordbiomedica.co.uk.
TroVax® is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen which is present on most solid tumours. The product comprises a modified vaccinia virus Ankara (MVA) vector, encoding the 5T4 antigen. Vaccinia viruses are commonly used as delivery systems for the development of antigen-specific vaccines. Results from 10 previous clinical trials in colorectal, renal and prostate cancer have shown that TroVax® is safe and well tolerated in over 500 patients; can be administered in combination with various other treatments and show clear indication of efficacy. Approximately 90% of patients treated with TroVax® mounted an anti-cancer immune response to the 5T4 antigen.
This information is provided by RNS