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2007/OB/01
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Oxford BioMedica's Phase III trial of TroVax® in renal cancer adopted by UK clinical trial network
Oxford, UK - 10 January 2007: Oxford BioMedica (LSE: OXB), a leading gene therapy company, today announced that the Phase III TRIST trial of its novel cancer immunotherapy, TroVax, in patients with renal cancer, has been adopted by the UK National Cancer Research Network (NCRN).
The NCRN provides the UK National Health Service (NHS) with the infrastructure to support cancer clinical trials. The NCRN's adoption of Oxford BioMedica's TRIST trial means that various NHS centres are able to participate in the study, which should facilitate rapid recruitment of patients in the UK. The UK Department of Health established the NCRN in April 2001 and it has already succeeded in doubling patient recruitment into cancer clinical trials. In reaching its decision to adopt the TRIST trial, the Renal Cancer Clinical Study Group of the NCRN evaluated TroVax and the trial design, and concluded that the product offers potential improvement in patient care for the NHS. There are no financial obligations or loss of commercial rights through NCRN's involvement.
TRIST (TroVax Renal Immunotherapy Survival Trial) is a multi-centre Phase III trial of TroVax in patients with advanced or metastatic renal cell carcinoma. The first patient was treated in the TRIST study in November 2006. Sites are currently open in the European Union and Eastern Europe. Oxford BioMedica anticipates US sites to start recruiting patients shortly. The target is to recruit 700 patients in total and the trial is expected to reach a conclusion in 2008-09, which would support the Company's objective of reaching product registration in 2009.
Professor Barry Hancock, Chairman of the National Cancer Research Institute Clinical Studies Group, said: "We are very pleased to support this study. TroVax appears particularly well tolerated and is effective at inducing a significant immune response against a protein which marks out tumour cells. There is a real need for novel, safe and effective treatments for this aggressive form of cancer. We aim to facilitate rapid patient recruitment through the participation of our network of centres in the UK."
Dr Mike McDonald, Oxford BioMedica's Chief Medical Officer, commented on the NCRN news: "The involvement of NCRN in the first Phase III trial of TroVax is a strong endorsement of the product and the trial design. Patient recruitment is now underway in several countries but we are particularly pleased that, through the NCRN, we will have the participation of additional UK centres."
Professor Alan Kingsman, Oxford BioMedica's Chief Executive Officer commented: "We are delighted that NCRN has adopted TRIST in the UK. The ongoing recruitment continues to enhance the value of the TroVax portfolio as we make progress towards a deal for this exciting product. "
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| Notes
| 1. |
Oxford
BioMedica plc |
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Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development of novel gene-based therapeutics with a focus on oncology and neurotherapy. The Company was established in 1995 as a spin out from Oxford University, and is listed on the London Stock Exchange.
Oxford
Oxford BioMedica has core expertise in gene delivery, as well as in-house clinical, regulatory and manufacturing know-how. In oncology, the pipeline includes two clinical candidates and a preclinical targeted antibody therapy, which is being developed in collaboration with Wyeth. The Company has started Phase III development of its lead cancer immunotherapy product, TroVax, in renal cancer and multiple Phase II trials in various cancer settings are ongoing or planned. In neurotherapy, the Company's lead product, ProSavin, is expected to enter clinical trials in Parkinson's disease in 2007. The preclinical pipeline includes gene-based products for vision loss, motor neuron disease and nerve repair.
The
The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 70 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Sigma-Aldrich, Viragen, MolMed, Virxsys and Kiadis; and has licensed technology to a number of companies including Merck & Co, Biogen Idec, GSK and Pfizer.
Further information is available at www.oxfordbiomedica.co.uk |
| 2. |
TroVax® |
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TroVax is Oxford BioMedica's leading cancer immunotherapy product. It is designed specifically to stimulate an anti-cancer immune response and has potential application in most solid tumour types. TroVax targets the tumour antigen 5T4, which is broadly distributed throughout a wide range of solid tumours. The presence of 5T4 is correlated with poor prognosis. The product consists of a poxvirus (MVA) gene transfer system, which delivers the gene for 5T4 and stimulates a patient's body to produce an anti-5T4 immune response. This immune response destroys tumour cells carrying the 5T4. The Company is targeting colorectal cancer and renal cell carcinoma as lead indications for the development of TroVax. Oxford BioMedica has started a Phase III trial (TRIST) in advanced renal cell carcinoma. A Phase II trial in prostate cancer is ongoing and a trial in breast cancer is due to start under the auspices of the US Southwest Oncology Group.
To date, over 160 patients with colorectal, renal or prostate cancer (collectively over 550 doses) have been treated with TroVax. The product has attracted support from Cancer Research UK, the US National Cancer Institute, and the UK clinical trials network, QUASAR. These organisations are already conducting or plan to conduct clinical trials with TroVax. |
| 3. |
Phase III TRIST Trial |
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TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial that is designed to evaluate whether TroVax immunotherapy, added to first-line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomised, placebo-controlled, two-arm study that will compare TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies will be interleukin-2, interferon-alpha or Sutent® (sunitinib). The protocol stratifies treatment between the standard of care options to ensure that the allocation of TroVax and placebo is rigorously balanced.
Patient enrolment commenced in November 2006. Approximately 700 patients will be recruited from about 120 centres in the USA, European Union and Eastern Europe. The primary endpoint for the trial is survival improvement and secondary endpoints include progression-free survival, tumour response rates and quality of life scores. A Safety and Efficacy Monitoring Board (SEMB) will assess the safety and potential efficacy of the drug combinations at various time points during the trial. In May 2006, Oxford BioMedica received a Special Protocol Assessment agreement for the TRIST study from the US Food and Drug Administration.
Median survival for patients with advanced or metastatic renal cell carcinoma is approximately 11 months. The duration of the trial will be determined by the number of survival events (deaths) in the study group and it is expected to reach a conclusion in 2008-09.
www.trovax.co.uk
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The National Cancer Research Network |
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The National Cancer Research Network (NCRN) was created in response to the need to improve the infrastructure within the UK National Health Service (NHS) for clinical research in cancer and to ensure that research is better integrated with cancer care as outlined in the 2000 Report of the Science and Technology Committee on Cancer Research. The NCRN provides the NHS with the infrastructure to support cancer clinical trials in England. Its aim is to improve the speed, quality and integration of research with the ultimate aim of improving patient care. NCRN was established by the Department of Health in April 2001 and has already succeeded in doubling patient accrual into cancer clinical trials.
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