Oxford BioMedica Announces Initiation of Phase II Collaborative Study for TroVax® in Colorectal Cancer

OXFORD, England, July 10, 2012 /PRNewswire/ --

-- First patient treated at Cardiff University, Wales (UK) --

Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE: OXB), the leading gene-based biopharmaceutical company, today announces that its partners at Cardiff University, Wales (UK) have initiated a Phase II trial to assess the safety and immunological activity of TroVax^®, a therapeutic vaccine developed by Oxford BioMedica, in patients with inoperable metastatic colorectal cancer (CRC).  The study will be funded by Cardiff University, with some funding awarded by Cancer Research Wales, and Oxford BioMedica will provide TroVax^®.  The trial is supported by the Experimental Cancer Medicine Centre (ECMC), Cardiff.

The randomised, open-label Phase II study, entitled "TaCTiCC" (TroVax^® and Cyclophosphamide Treatment in Colorectal Cancer), builds on four previous Phase I/II trials conducted by Oxford BioMedica where TroVax^® was given to patients with CRC, in addition to research into CRC undertaken by Dr Andrew Godkin and Dr Awen Gallimore at Cardiff University, Wales.  Led by Dr Andrew Godkin, the study will enrol up to 54 patients with inoperable metastatic CRC.  The study will evaluate whether TroVax^®, administered alone or in combination with cyclophosphamide, is effective in the treatment of CRC.  The study will assess anti-5T4 immune responses following treatment, in addition to secondary measures of clinical benefit including progression-free survival, objective response rate and overall survival.

Colorectal cancer is the second most common cause of cancer mortality in the UK with an estimated 16,000 deaths per year (source: Cancer Research UK, 2010).  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.  It is well documented that low doses of cyclophosphamide can augment immune responses by decreasing the numbers of a class of blood cell called a "regulatory T cell".  By combining TroVax^® with cyclophosphamide, this study will determine whether the combination approach results in stronger immune responses against 5T4 compared to patients treated with TroVax^® alone.

Commenting on the collaboration, Stuart Naylor, Chief Scientific Officer at Oxford BioMedica, said: "We believe TroVax^® holds great promise in the treatment of colorectal cancer and very much look forward to working with our colleagues at CardiffUniversity.  This important study builds on pioneering work undertaken by Dr Godkin and his team and we are pleased to be able to support the transition into Phase II clinical development."

Dr Andrew Godkin, Principal Investigator at CardiffUniversity, commented: "We are very excited in Cardiff to be starting this study.  It is a truly translational study in as much as preliminary data have been generated from a series of experiments which started over 10 years ago.  There has been a tremendous amount of support from various parties to drive this forward, the logistic hurdles are crossed and we are now ready to go."

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 http://www.oxfordbiomedica.co.uk.

2. TroVax^®

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.  TroVax^® is currently in Phase II development for hormone refractory prostate cancer.

3. The School of Medicine, Cardiff University

Cardiff University's School of Medicine is recognised as a significant contributor to healthcare in Wales, a major provider of professional staff for the National Health Service and an international centre of excellence for research delivering substantial health benefits locally and internationally.  The School of Medicine is based at the Heath Park Campus, a site it shares the University Hospital of Wales, the third largest university hospital in the UK.  It has an all-Wales role, contributing greatly to promoting, enhancing and protecting the nation's health in partnership with the National Health Service (NHS) in Wales.  The medical curriculum followed at the School enables students to acquire and apply knowledge, skills, judgement and attitudes appropriate to delivering a high standard of professional care.  The School is an international leader in basic and clinically applied research activities and has been instrumental in establishing and running many important national research initiatives including the Wales Gene Park, Wales Cancer Bank, the Cardiff Institute for Tissue Engineering and Repair and the Healing Foundation UK Centre for Burns Research.

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