Oxford Biomedica Announces Data Safety Monitoring Board Recommendation to ContinueTroVax(R) Phase III Trial in Renal Cancer

The DSMB concluded that the trial should continue as planned without modification



OXFORD, UK | December 10, 2007 |
2007:Oxford BioMedica (LSE: OXB), a leading gene therapy company, announced today that the independent Data Safety Monitoring Board (DSMB) for the Phase III TRIST study of TroVax in renal cancer has completed its second planned interim analysis. The DSMB concluded that the trial should continue as planned without modification. TroVax is Oxford BioMedica’s novel cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis.

The role of the DSMB is to evaluate data from the ongoing trial to determine whether there are safety issues or efficacy issues that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Oxford BioMedica and sanofi-aventis and is comprised of leading clinicians and biostatisticians with relevant expertise in the treatment of renal cancer and the conduct of clinical trials.

TRIST (TroVax Renal Immunotherapy Survival Trial) is a Phase III trial of TroVax in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies are 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.

The trial started in November 2006. To date, more than 500 patients have been randomised of a target enrolment of approximately 700 patients. Over 100 sites in the USA, European Union and Eastern Europe are recruiting patients. The primary endpoint for the trial is overall survival in the TroVax-treated group versus the placebo group. Secondary endpoints include progression-free survival at 26 weeks, tumour response rates and quality of life scores. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). The SPA agreement ensures that the design, conduct, analysis and endpoints of the trial are all acceptable to the FDA.

Dr Mike McDonald, Oxford BioMedica’s Chief Medical Officer, commented on the DSMB recommendation: “This interim analysis by the DSMB is an important step in the progress of the TRIST study. It is the first analysis that compares the safety and efficacy of the TroVax and placebo arms of the study. We are delighted by the positive recommendation. We remain on track to complete patient enrolment during Q1 2008 and we anticipate final results in 2009.”

1. Oxford BioMedica plc

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the development and commercialisation of novel therapeutic vaccines and gene-based therapies 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.

The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. In oncology, the lead product candidate is TroVax®, an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis for global development and commercialisation. A Phase III trial of TroVax in renal cancer is ongoing and two Phase III trials in colorectal cancer are planned. Oxford BioMedica has two other anti-cancer product candidates in Phase II development for melanoma and pancreatic cancer respectively. In neurotherapy, the Company has submitted a Clinical Trial Application to start a Phase I/II trial of its gene-based treatment for Parkinson’s disease, ProSavin®. The neurotherapy pipeline also includes preclinical gene-based therapeutics for vision loss, motor neuron disease and nerve repair.

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 80 split between its main facilities in Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California. Corporate partners include sanofi-aventis for TroVax and Wyeth for an anti-cancer targeted antibody therapy. The Company also has collaborations with Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer.

Further information is available at www.oxfordbiomedica.co.uk

2. TroVax®

TroVax is Oxford BioMedica’s leading cancer immunotherapy product, which is being developed in collaboration with sanofi-aventis. 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. Oxford BioMedica and Sanofi-aventis entered a global development and commercialisation agreement for TroVax in March 2007. The companies are co-funding a Phase III trial of TroVax in renal cancer and sanofi-aventis is implementing a Phase III development plan for colorectal cancer. The product has also attracted support from Cancer Research UK, the US National Cancer Institute, and the UK clinical trials network, QUASAR.

3. Phase III TRIST study

The Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) study commenced in November 2006 in patients with locally advanced or metastatic clear cell renal carcinoma. The trial is a randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The standard of care therapies are Sutent®(sunitinib), interferon-alpha or interleukin-2. The trial is being conducted at centres in the USA, European Union and Eastern Europe. The primary endpoint for the trial is survival improvement. The trial, which commenced enrolment in November 2006, is being conducted under a Special Protocol Assessment (SPA) agreement from the US Food and Drug Administration (FDA). The trial is expected to complete in 2009. For more information on the ongoing Phase III TRIST study of TroVax visit: www.trovax.co.uk
4. Renal cancer

Renal cell carcinoma (RCC) is the most common form of kidney cancer in the USA, accounting for nine out of ten cases of the disease. More than 150,000 people are newly diagnosed with RCC worldwide each year. Prognosis is very poor. If RCC has metastasised to other organs at the time of first diagnosis, the five-year survival rate is less than 5%. In the USA and Europe, RCC accounts for more than 33,000 deaths each year. Treatment options for patients with kidney cancer are limited. Surgical removal of the tumour tends only to be successful in early-stage disease. As the disease progresses, there are several commonly used therapies including immunostimulatory cytokines and kinase inhibitors.

SOURCE: Oxford BioMedica

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