Oxford BioMedica's Trovax receives positive recommendation for orphan drug designation in renal cancer from EMEA
Oxford BioMedica, a gene therapy company, has received positive opinion from the Committee for Orphan Medicinal Products (Comp) recommending orphan drug designation for TroVax for the treatment of patients with renal cancer in the European Union (EU).
The Comp is part of the European Medicines Agency (EMEA).
Final adoption of the opinion is expected from the European Commission in early 2007.
European orphan drug designation ensures a ten-year marketing exclusivity for TroVax within the EU.
In addition, Oxford BioMedica and its prospective partner will benefit from a simplified, accelerated and cost-effective approval procedure under the consultative guidance of the EMEA.
The company plans to request the equivalent orphan drug status in the USA.
EU orphan drug designation 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 are rare and affect not more than five in 10,000 persons 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.
Prognosis is very poor.
If renal cancer 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, renal cancer accounts for more than 33,000 deaths each year.
Data from IMS suggest that over 5000 patients in the UK received treatment for metastatic renal cancer in 2005.
Mike McDonald, Oxford BioMedica's chief medical officer, commented on the news: "This positive recommendation from the EMEA 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".
Oxford BioMedica commenced a pivotal multi-centre phase III trial of TroVax in renal cancer in November 2006.
The phase III trial, denoted Trist (Trovax renal immunotherapy survival trial), 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.
Approximately 700 patients will be recruited from about 120 centres in the USA, EU and Eastern Europe.
The primary endpoint for the trial is survival improvement.
Oxford BioMedica received a special protocol assessment agreement for the Trist study from the US Food and Drug Administration (FDA).
The trial is expected to reach a conclusion in 2008-09, which would support the company's objective of reaching product registration in 2009 in the USA and 2010 in the EU.
Oxford BioMedica has a key strategic objective of securing a major corporate partner for the ongoing development and commercialisation of TroVax.
The company has progressed to negotiations of terms with its lead prospective partners and remains committed to finalising a deal expeditiously.
