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TroVax a step nearer to orphan status

Published on 08/12/06 at 03:11pm

Oxford BioMedica's leading cancer immunotherapy vaccine has received a positive opinion as an orphan drug for renal cancer from the Committee for Orphan Medicinal Products.

Final approval for TroVax is expected from the EU in early 2007.

The recommendation comes as Oxford BioMedica begins a pivotal multi-centre phase III trial of TroVax in renal cancer, designed to find out whether its immunotherapy, added to first-line treatment, prolongs the survival of patients with locally advanced or metastatic clear cell renal cancer.

The TroVax Renal Immunotherapy Survival Trial (TRIST) will recruit approximately 700 patients from the EU, Eastern Europe and the US. The trial is expected to reach a conclusion in 2008-09  which would support the company's objective of filing the product in the US in 2009 and in Europe in 2010.

Orphan drug status was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that only affect around five in every 10,000 people in the EU.

Renal cancer represents any malignant tumour with its origin in the tissues of the kidneys. More than 150,000 people are newly diagnosed with renal cancer worldwide each year, and in Europe and the US it accounts for more than 33,000 deaths every year.

Dr Mike McDonald, Oxford BioMedica's chief medical officer, said: "This positive recommendation for orphan drug designation adds further momentum to the development of TroVax. It underscores the need for effective treatments for renal cancer where treatment options are limited and the prognosis is poor."

Three further small phase II studies are due to start in renal cell cancer, to evaluate TroVax in combination with interferon-a and Pfizer's Sutent (sunitnib).

Trovax has also received US funding for a phase II trial into patients with late-stage breast cancer. Patients will receive monthly injections of the vaccine for three months, followed by booster immunisations at six, nine and 12 months. Key endpoints will include immunological response rates to the 5TA tumour antigen, which is present in over 80% of breast cancer cases.

The development of cancer vaccines is becoming a fast-growing and competitive market. A recent report from analysts Arrowhead estimated the market would probably be worth around $6 billion before the end of the decade.

Two US companies, San Francisco's Cell Genesys and Seattle-based Dendreon, currently have prostate cancer products in phase III, whilst UK-based Onyvax has a prostate cancer product in phase II.

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