Phase II TroVax® trial begins

March 19, 2013

Oxford BioMedica plc, a leading gene-based biopharmaceutical company, has announced that its partners at the Velindre Cancer Centre, one of the largest cancer centres in the UK, have initiated a Phase II trial to assess the safety and immunological activity of TroVax®, a therapeutic vaccine developed by Oxford BioMedica, in combination with first-line chemotherapy agents pemetrexed and cisplatin in patients with malignant pleural mesothelioma. The study will be funded by the June Hancock Mesothelioma Research Fund (JHMRF) and the Venlindre Cancer Centre Stepping Stones Appeal, and Oxford BioMedica will provide TroVax®.

The Phase II study, entitles ‘SKOPOS’, will be led by Dr Jason Lester at Velindre Cancer Centre in Cardiff, Wales, with Dr Zsuzsanna Tabi as co-investigator, and will enrol 26 patients with malignant pleural mesothelioma (MPM). The study will evaluate whether TroVax® is active in the treatment of MPM, assessed by measuring anti-5T4 immune responses following treatment in combination with pemetrexed and cisplatin. The study will also assess secondary measures of clinical benefit including progression-free survival, objective response rate and overall survival at six and 12 months.

TroVax® is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5TA tumour antigen which is present on most solid tumours. Dr Zsuzsanna Tabi at Cardiff University and a team of cancer immunologists previously undertook a feasibility project, also funded by JHMRF, where the 5TA tumour antigen was shown to be present on mesothelioma cells. Mesothelioma is a relatively rare form of cancer which affects the tissue lining of the lungs (the pleura) and, less commonly, the lining of the abdomen (the peritoneum). The disease can take 10 to 50 years or longer to develop and is usually associated with asbestos exposure. It is estimates that every five hours someone dies form mesothelioma in the UK and the annual number of deaths is expected to remain above 1,500 until 2025.

Commenting on the collaboration, John Dawson, Chief Executive Officer of Oxford BioMedica said, “This study is the first to evaluate TroVax® as a treatment for mesothelioma in the UK and we are privileged to be working with the immunology team at Velindre Cancer Centre. TroVax® has been shown to be effective at inducing immune responses in multiple types of cancer and, with few treatment options available for mesothelioma, could hold significant promise against this increasingly prevalent form of cancer.”

Dr Jason Lester, Chief Investigator at Velindre Cancer Centre, comments, “I am delighted that the SKOPOS study is now open. Mesothelioma is one of the hardest cancers to treat and can be very debilitating for patients. We are hopeful that TroVax® in combination with chemotherapy will show promise and lead to better outcomes for patients with mesothelioma.”

Dr Kate Hill, trustee of the June Hancock Mesothelioma Research Fund, said, “Given the limited options available for the treatment of mesothelioma, the Fund is thrilled to support the SKOPOS study. We are also delighted to continue our association with the Velindre Cancer Centre and enable the valuable laboratory work previously funded by JHMRF to move to the next stage. There is no doubt that new approaches to treating mesothelioma are needed; this study is an important step forward.”

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